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Evaluation of Fondaparinux in Patients With a Heart Rhythm Disturbance Who Undergo Restoration of Normal Heart Rhythm

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ClinicalTrials.gov Identifier: NCT00911300
Recruitment Status : Completed
First Posted : June 1, 2009
Results First Posted : September 5, 2012
Last Update Posted : October 1, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Fibrillation, Atrial
Interventions Drug: fondaparinux
Drug: unfractionated heparin
Drug: Vitamin-K-Antagonist
Enrollment 349
Recruitment Details  
Pre-assignment Details Participants (par.) were required to undergo transesophageal echocardiography (TEE) to guide cardioversion (CV). TEEs were recorded and archived to allow for later central adjudication and possible evaluation of details. At randomization (Day 1, immediately after TEE), par. were stratified to thrombus (clot)-positive and thrombus (clot)-negative.
Arm/Group Title Fondaparinux Unfractioned Heparin (UFH)/Vitamin K Antagonist (VKA)
Hide Arm/Group Description For clot-negative (CN) participants (par.), 7.5 milligrams (mg) fondaparinux was injected once daily (OD) subcutaneously (for par. with body weight [BW] 50-100 kilograms [kg]); for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For clot-positive (CP) par. with creatinine clearance (CrCl) >= 50 milliliters (mL)/minute (min), 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days). Both CN and CP participants received an initial intravenous (i.v.) bolus injection of 70 international units (IU)/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/hour (h) (at least 1250 IU per hour). The infusion dose was adjusted to maintain an activated partial thromboplastin time (aPTT) at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target international normalized ratio (INR) of 2.0-3.0. UFH was continued until INR >2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
Period Title: Overall Study
Started 175 174
Completed 140 131
Not Completed 35 43
Reason Not Completed
Primary Endpoint Component Occurred             1             2
Death             1             0
Thrombus Persistant in Second TEE             3             7
Adverse Event             14             6
Protocol Violation             3             2
Consent Withdrawn             4             12
Coronary Angiography Performed             1             0
Atrial Fibrillation (AF) Recurrence             3             3
Received Commercial Treatment             1             0
Recurrent Tachyarrhythmia             1             1
Recurrent Tachy-Arrhythmia Absoluta             1             1
Nurse Unavailable in Participant's City             1             0
CV Unsuccessful; Phenprocoumon Received             1             0
Participant Could Not Stay in Hospital             0             1
Investigator's Decision; New AF Episode             0             1
International Normalized Ratio Too High             0             1
Participant Refused Hospital Consulation             0             1
Underlying Disease (Myocarditis)             0             1
Physician Decision             0             1
Treatment Stopped by Mistake             0             1
Randomized; No Study Medication Received             0             2
Arm/Group Title Fondaparinux UFH/VKA Total
Hide Arm/Group Description For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days). Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR >2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days. Total of all reporting groups
Overall Number of Baseline Participants 174 170 344
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 174 participants 170 participants 344 participants
68.24  (11.09) 66.78  (11.93) 67.52  (11.52)
[1]
Measure Description: Baseline characteristic data were collected in members of the Modified Intent-to-Treat (mITT) Population, comprised of all randomized participants receiving at least one dose of study medication and for whom any post-baseline value was available.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 174 participants 170 participants 344 participants
Female
69
  39.7%
60
  35.3%
129
  37.5%
Male
105
  60.3%
110
  64.7%
215
  62.5%
[1]
Measure Description: Baseline characteristic data were collected in members of the Modified Intent-to-Treat (mITT) Population, comprised of all randomized participants receiving at least one dose of study medication and for whom any post-baseline value was available.
1.Primary Outcome
Title Number of Participants With at Least One Event of Cerebral Neurologic Event, Systemic Thromboembolism, Death From Any Cause, and/or Major Bleeding Until the End of Treatment (EOT) Plus 4 Days
Hide Description Cerebral neurologic events are defined as any new neurologic disorders caused by cerebrovascular embolization, e.g., Transient Ischemic Attack (TIA), cerebral infarction. The cerebrovascular origin of the event has to be confirmed by objective procedures. Systemic thromboembolism comprises any arterial thromboembolic event (e.g., peripheral vascular embolism, mesenteric infarct, or myocardial infarction). All cerebral neurologic events were adjudicated by a Central Adjudication Committee (CAC), members of which were unaware of the participants' treatment assignment.
Time Frame Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (mITT) Population: all randomized participants receiving at least one dose of study medication and for whom any post-baseline value was available
Arm/Group Title Fondaparinux UFH/VKA
Hide Arm/Group Description:
For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
Overall Number of Participants Analyzed 174 170
Measure Type: Number
Unit of Measure: participants
3 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fondaparinux, UFH/VKA
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage of participants
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
-2.0 to 3.1
Estimation Comments The estimated value is the absolute percent difference between Fondaparinux and UFH/VKA.
2.Secondary Outcome
Title Number of Thrombus-negative and Thrombus-positive Participants (Par.) With at Least One Cerebral Neurologic Event
Hide Description Cerebral neurologic events are defined as any new neurologic disorders caused by cerebrovascular embolisation, e.g., TIA, cerebral infarction. All cerebral neurologic events were adjudicated by a CAC, members of which were unaware of the participants' treatment assignment.The cerebrovascular origin of the event was confirmed by objective procedures. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors).
Time Frame Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Fondaparinux UFH/VKA
Hide Arm/Group Description:
For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
Overall Number of Participants Analyzed 174 170
Measure Type: Number
Unit of Measure: participants
Thrombus-negative par. until 4 days after EOT 0 1
Thrombus-positive par. until 4 days after EOT 0 0
Thrombus-negative participants until the FU 1 1
Thrombus-positive participants until the FU 0 0
3.Secondary Outcome
Title Number of Thrombus-negative and Thrombus-positive Participants With at Least One Systemic Thromboembolism
Hide Description Systemic thromboembolism comprises any arterial thromboembolic event (e.g., peripheral vascular embolism, mesenteric infarct, or myocardial infarction). All systemic thromboembolic events were adjudicated by a CAC, the members of which were unaware of the participants' treatment assignment. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors).
Time Frame Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Fondaparinux UFH/VKA
Hide Arm/Group Description:
For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
Overall Number of Participants Analyzed 174 170
Measure Type: Number
Unit of Measure: participants
Thrombus-negative par. until 4 days after EOT 0 0
Thrombus-positive par. until 4 days after EOT 0 0
Thrombus-negative participants until the FU 0 0
Thrombus-positive participants until the FU 0 0
4.Secondary Outcome
Title Number of Thrombus-negative and Thrombus-positive Participants Who Died From Any Cause
Hide Description The cause of death was classified as due to a thromboembolic event (like cerebral infarction), bleeding, or other established diagnosis, or as unexplained. All deaths were adjudicated by an independent CAC, the members of which were unaware of the participants' treatment assignment. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors).
Time Frame Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Fondaparinux UFH/VKA
Hide Arm/Group Description:
For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
Overall Number of Participants Analyzed 174 170
Measure Type: Number
Unit of Measure: participants
Thrombus-negative par. until 4 days after EOT 1 0
Thrombus-positive par. until 4 days after EOT 0 0
Thrombus-negative participants until the FU 3 0
Thrombus-positive participants until the FU 0 0
5.Secondary Outcome
Title Number of Thrombus-negative and Thrombus-positive Participants With at Least One Major Bleeding Event
Hide Description Major bleeding: fatal, and/or symptomatic in a critical area/ organ, causes a fall in hemoglobin of >=3 grams/deciliter compared with the pre-randomization level, or leads to the transfusion of >=2 units of whole blood/red blood cells. All bleeding events were adjudicated by a CAC, the members of which were unaware of the participants' treatment assignment. A thrombus/ blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets, and the activation of the humoral coagulation system (i.e., clotting factors).
Time Frame Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Fondaparinux UFH/VKA
Hide Arm/Group Description:
For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
Overall Number of Participants Analyzed 174 170
Measure Type: Number
Unit of Measure: participants
Thrombus-negative par. until 4 days after EOT 3 1
Thrombus-positive par. until 4 days after EOT 0 0
Thrombus-negative participants until the FU 4 1
Thrombus-positive participants until the FU 0 0
6.Secondary Outcome
Title Number of Thrombus-negative and Thrombus-positive Participants With at Least One Minor Bleeding Event
Hide Description Minor bleeding is defined as clinically overt bleeding events that do not meet the criteria for major or clinically relevant non-major bleeding. All episodes of bleeding were adjudicated by an independent CAC, the members of which were unaware of the participants' treatment assignment.
Time Frame Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Fondaparinux UFH/VKA
Hide Arm/Group Description:
For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
Overall Number of Participants Analyzed 174 170
Measure Type: Number
Unit of Measure: participants
Thrombus-negative par. until 4 days after EOT 3 4
Thrombus-positive par. until 4 days after EOT 0 0
Thrombus-negative participants until the FU 3 5
Thrombus-positive participants until the FU 1 0
7.Secondary Outcome
Title Number of Participants With Primary Successful Electrical Cardioversion (CV) in Sinus Rhythm
Hide Description CV may be performed electively to restore sinus rhythm in patients with persistent AF. The primary successful electric CV was assessed by a 12- lead electrocardiogram (ECG) directly after the CV. Results of the last cardioversion were used in cases for which more than one CV was performed.
Time Frame Day 1 until Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Only participants with data for primary successful electric cardioversion at the indicated timepoint were analyzed.
Arm/Group Title Fondaparinux UFH/VKA
Hide Arm/Group Description:
For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
Overall Number of Participants Analyzed 151 148
Measure Type: Number
Unit of Measure: participants
137 133
8.Secondary Outcome
Title Number of Participants With a Thrombus in the Left Atrium (LA) or in the Left Atrial Appendage (LAA) at the Time of the Second TEE
Hide Description Atrial fibrillation (AF) causes stagnant blood in the LA or LAA and can lead to a thromboembolism. Stasis in the LAA represents the principal mechanism of thrombus formation in AF.
Time Frame At second TEE (at Day 28+/-4)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population. Only clot-positive participants at the time of the first TEE were analyzed.
Arm/Group Title Fondaparinux UFH/VKA
Hide Arm/Group Description:
For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
Overall Number of Participants Analyzed 14 14
Measure Type: Number
Unit of Measure: participants
3 7
9.Secondary Outcome
Title Number of Thrombus-negative and Thrombus-positive Participants With Conversion to Sinus Rhythm
Hide Description Sinus rhythm is the normal beating of the heart, as measured by an ECG. Normal sinus rhythm not only indicates that the rhythm is normally generated by the sinus node and is traveling in a normal fashion in the heart, but it also indicates that the heart rate (the rate at which the sinus node is generating impulses) is within normal limits.
Time Frame Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Day 64 until the follow-up visit (FU) (Day 90+/-7)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Fondaparinux UFH/VKA
Hide Arm/Group Description:
For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
Overall Number of Participants Analyzed 174 170
Measure Type: Number
Unit of Measure: participants
Clot-negative par. until 4 days after EOT 109 115
Clot-positive par. until 4 days after EOT 5 4
Clot-negative participants until the FU 105 106
Clot-positive participants until the FU 4 5
10.Secondary Outcome
Title Number of Participants Who Were Re-hospitalized
Hide Description Hospitalization signifies that the participant has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician’s office or out-patient setting. Re-hospitalization refers to an event of hospitalization after discharge for the initial hospitilization for the cardioversion.
Time Frame Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Fondaparinux UFH/VKA
Hide Arm/Group Description:
For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
Overall Number of Participants Analyzed 174 170
Measure Type: Number
Unit of Measure: participants
until 4 days after EOT 14 7
until the FU 18 11
Time Frame Participants were analyzed for the period from randomization up to the last administration of study treatment plus four days (up to Day 56+/-4 days).
Adverse Event Reporting Description Serious adverse events (SAEs) and non-serious AEs were collected in members of the Safety Population, comprised of all participants included in the study, who had any post-baseline value, and who received at least one dose of study medication.
 
Arm/Group Title Fondaparinux UFH/VKA
Hide Arm/Group Description For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days). Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR >2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
All-Cause Mortality
Fondaparinux UFH/VKA
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fondaparinux UFH/VKA
Affected / at Risk (%) Affected / at Risk (%)
Total   30/174 (17.24%)   26/170 (15.29%) 
Cardiac disorders     
Atrial fibrillation  1  12/174 (6.90%)  5/170 (2.94%) 
Cardiac failure  1  4/174 (2.30%)  3/170 (1.76%) 
Angina pectoris  1  1/174 (0.57%)  1/170 (0.59%) 
Atrial flutter  1  0/174 (0.00%)  2/170 (1.18%) 
Cardiac failure congestive  1  1/174 (0.57%)  1/170 (0.59%) 
Tachyarrhythmia  1  0/174 (0.00%)  2/170 (1.18%) 
Arrhythmia supraventricular  1  0/174 (0.00%)  1/170 (0.59%) 
Atrioventricular block complete  1  1/174 (0.57%)  0/170 (0.00%) 
Cardiac valve disease  1  1/174 (0.57%)  0/170 (0.00%) 
Coronary artery disease  1  1/174 (0.57%)  0/170 (0.00%) 
Ischemic cardiomyopathy  1  0/174 (0.00%)  1/170 (0.59%) 
Mitral valve incompetence  1  1/174 (0.57%)  0/170 (0.00%) 
Sinoatrial block  1  0/174 (0.00%)  1/170 (0.59%) 
Gastrointestinal disorders     
Gastrointestinal hemorrhage  1  1/174 (0.57%)  1/170 (0.59%) 
Colonic polyp  1  0/174 (0.00%)  1/170 (0.59%) 
Diarrhea  1  1/174 (0.57%)  0/170 (0.00%) 
Erosive esophagitis  1  0/174 (0.00%)  1/170 (0.59%) 
Vomiting  1  1/174 (0.57%)  0/170 (0.00%) 
General disorders     
Death  1  1/174 (0.57%)  0/170 (0.00%) 
Infections and infestations     
Gastroenteritis  1  1/174 (0.57%)  0/170 (0.00%) 
Staphylococcal sepsis  1  0/174 (0.00%)  1/170 (0.59%) 
Injury, poisoning and procedural complications     
Fall  1  0/174 (0.00%)  1/170 (0.59%) 
Metabolism and nutrition disorders     
Hypokalemia  1  1/174 (0.57%)  0/170 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/174 (0.00%)  1/170 (0.59%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bronchial carcinoma  1  1/174 (0.57%)  0/170 (0.00%) 
Colon cancer  1  1/174 (0.57%)  0/170 (0.00%) 
Neoplasm skin  1  1/174 (0.57%)  0/170 (0.00%) 
Rectal cancer  1  0/174 (0.00%)  1/170 (0.59%) 
Nervous system disorders     
Cerebrovascular accident  1  1/174 (0.57%)  1/170 (0.59%) 
Syncope  1  1/174 (0.57%)  1/170 (0.59%) 
Cerebral infarction  1  1/174 (0.57%)  0/170 (0.00%) 
Renal and urinary disorders     
Renal failure acute  1  1/174 (0.57%)  1/170 (0.59%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  1/174 (0.57%)  2/170 (1.18%) 
Pulmonary edema  1  1/174 (0.57%)  1/170 (0.59%) 
Skin and subcutaneous tissue disorders     
Skin necrosis  1  0/174 (0.00%)  1/170 (0.59%) 
Vascular disorders     
Hematoma  1  1/174 (0.57%)  2/170 (1.18%) 
Hypertensive crisis  1  1/174 (0.57%)  0/170 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fondaparinux UFH/VKA
Affected / at Risk (%) Affected / at Risk (%)
Total   68/174 (39.08%)   70/170 (41.18%) 
Blood and lymphatic system disorders     
Anemia  1  1/174 (0.57%)  0/170 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  13/174 (7.47%)  11/170 (6.47%) 
Bradycardia  1  2/174 (1.15%)  2/170 (1.18%) 
Angina pectoris  1  0/174 (0.00%)  1/170 (0.59%) 
Atrial flutter  1  0/174 (0.00%)  1/170 (0.59%) 
Atrioventricular block first degree  1  0/174 (0.00%)  1/170 (0.59%) 
Cardiac failure  1  1/174 (0.57%)  0/170 (0.00%) 
Mitral valve incompetence  1  1/174 (0.57%)  0/170 (0.00%) 
Palpitations  1  0/174 (0.00%)  1/170 (0.59%) 
Sinus bradycardia  1  0/174 (0.00%)  1/170 (0.59%) 
Supraventricular extrasystoles  1  1/174 (0.57%)  0/170 (0.00%) 
Tricuspid valve incompetence  1  1/174 (0.57%)  0/170 (0.00%) 
Ventricular tachycardia  1  1/174 (0.57%)  0/170 (0.00%) 
Ear and labyrinth disorders     
Vertigo  1  5/174 (2.87%)  3/170 (1.76%) 
Tinnitus  1  0/174 (0.00%)  1/170 (0.59%) 
Endocrine disorders     
Hyperthyroidism  1  0/174 (0.00%)  1/170 (0.59%) 
Hypothyroidism  1  0/174 (0.00%)  1/170 (0.59%) 
Eye disorders     
Vision blurred  1  0/174 (0.00%)  1/170 (0.59%) 
Gastrointestinal disorders     
Diarrhea  1  3/174 (1.72%)  5/170 (2.94%) 
Vomiting  1  6/174 (3.45%)  1/170 (0.59%) 
Constipation  1  3/174 (1.72%)  3/170 (1.76%) 
Nausea  1  4/174 (2.30%)  2/170 (1.18%) 
Abdominal pain upper  1  0/174 (0.00%)  2/170 (1.18%) 
Abdominal discomfort  1  0/174 (0.00%)  1/170 (0.59%) 
Abdominal pain  1  1/174 (0.57%)  0/170 (0.00%) 
Dry mouth  1  1/174 (0.57%)  0/170 (0.00%) 
Dysphagia  1  0/174 (0.00%)  1/170 (0.59%) 
Gastric disorder  1  1/174 (0.57%)  0/170 (0.00%) 
Gastrointestinal pain  1  0/174 (0.00%)  1/170 (0.59%) 
Intestinal hemorrhage  1  1/174 (0.57%)  0/170 (0.00%) 
Toothache  1  0/174 (0.00%)  1/170 (0.59%) 
General disorders     
Edema  1  4/174 (2.30%)  3/170 (1.76%) 
Chest pain  1  4/174 (2.30%)  2/170 (1.18%) 
Edema peripheral  1  1/174 (0.57%)  3/170 (1.76%) 
Chest discomfort  1  0/174 (0.00%)  3/170 (1.76%) 
Asthenia  1  1/174 (0.57%)  0/170 (0.00%) 
Fatigue  1  1/174 (0.57%)  0/170 (0.00%) 
Vessel puncture site hematoma  1  1/174 (0.57%)  0/170 (0.00%) 
Infections and infestations     
Urinary tract infection  1  3/174 (1.72%)  3/170 (1.76%) 
Nasopharyngitis  1  1/174 (0.57%)  2/170 (1.18%) 
Lung infection  1  1/174 (0.57%)  1/170 (0.59%) 
Bronchitis  1  0/174 (0.00%)  1/170 (0.59%) 
Cystitis  1  1/174 (0.57%)  0/170 (0.00%) 
Gastroenteritis norovirus  1  0/174 (0.00%)  1/170 (0.59%) 
Infection  1  1/174 (0.57%)  0/170 (0.00%) 
Onychomycosis  1  0/174 (0.00%)  1/170 (0.59%) 
Paronychia  1  0/174 (0.00%)  1/170 (0.59%) 
Sebaceous gland infection  1  1/174 (0.57%)  0/170 (0.00%) 
Varicella  1  0/174 (0.00%)  1/170 (0.59%) 
Injury, poisoning and procedural complications     
Contusion  1  2/174 (1.15%)  0/170 (0.00%) 
Ankle fracture  1  1/174 (0.57%)  0/170 (0.00%) 
Joint sprain  1  1/174 (0.57%)  0/170 (0.00%) 
Wound  1  1/174 (0.57%)  0/170 (0.00%) 
Investigations     
C-reactive protein increased  1  0/174 (0.00%)  2/170 (1.18%) 
Blood creatinine increased  1  0/174 (0.00%)  1/170 (0.59%) 
Blood potassium decreased  1  0/174 (0.00%)  1/170 (0.59%) 
International normalised ratio decreased  1  0/174 (0.00%)  1/170 (0.59%) 
International normalized ratio increased  1  0/174 (0.00%)  1/170 (0.59%) 
Weight decreased  1  1/174 (0.57%)  0/170 (0.00%) 
Metabolism and nutrition disorders     
Hypokalemia  1  4/174 (2.30%)  2/170 (1.18%) 
Gout  1  0/174 (0.00%)  2/170 (1.18%) 
Hyperkalemia  1  2/174 (1.15%)  0/170 (0.00%) 
Appetite disorder  1  1/174 (0.57%)  0/170 (0.00%) 
Hypercholesterolaemia  1  0/174 (0.00%)  1/170 (0.59%) 
Magnesium deficiency  1  0/174 (0.00%)  1/170 (0.59%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  0/174 (0.00%)  2/170 (1.18%) 
Musculoskeletal pain  1  1/174 (0.57%)  1/170 (0.59%) 
Arthralgia  1  1/174 (0.57%)  0/170 (0.00%) 
Myalgia  1  1/174 (0.57%)  0/170 (0.00%) 
Osteoarthritis  1  0/174 (0.00%)  1/170 (0.59%) 
Pain in extremity  1  1/174 (0.57%)  0/170 (0.00%) 
Sensation of heaviness  1  1/174 (0.57%)  0/170 (0.00%) 
Spinal disorder  1  1/174 (0.57%)  0/170 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostatic adenoma  1  0/174 (0.00%)  1/170 (0.59%) 
Nervous system disorders     
Headache  1  7/174 (4.02%)  0/170 (0.00%) 
Dizziness  1  1/174 (0.57%)  2/170 (1.18%) 
Syncope  1  0/174 (0.00%)  2/170 (1.18%) 
Paraesthesia  1  1/174 (0.57%)  0/170 (0.00%) 
Restless legs syndrome  1  0/174 (0.00%)  1/170 (0.59%) 
Psychiatric disorders     
Sleep disorder  1  2/174 (1.15%)  4/170 (2.35%) 
Insomnia  1  1/174 (0.57%)  2/170 (1.18%) 
Disorientation  1  0/174 (0.00%)  1/170 (0.59%) 
Nightmare  1  0/174 (0.00%)  1/170 (0.59%) 
Transient psychosis  1  0/174 (0.00%)  1/170 (0.59%) 
Renal and urinary disorders     
Renal cyst  1  1/174 (0.57%)  0/170 (0.00%) 
Renal failure  1  1/174 (0.57%)  0/170 (0.00%) 
Renal impairment  1  1/174 (0.57%)  0/170 (0.00%) 
Reproductive system and breast disorders     
Menstruation irregular  1  1/174 (0.57%)  0/170 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  1/174 (0.57%)  4/170 (2.35%) 
Cough  1  3/174 (1.72%)  1/170 (0.59%) 
Epistaxis  1  2/174 (1.15%)  2/170 (1.18%) 
Oropharyngeal pain  1  1/174 (0.57%)  2/170 (1.18%) 
Hemoptysis  1  1/174 (0.57%)  1/170 (0.59%) 
Pleural effusion  1  2/174 (1.15%)  0/170 (0.00%) 
Bronchial disorder  1  1/174 (0.57%)  0/170 (0.00%) 
Pulmonary hypertension  1  1/174 (0.57%)  0/170 (0.00%) 
Rhinalgia  1  1/174 (0.57%)  0/170 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  2/174 (1.15%)  2/170 (1.18%) 
Pruritus  1  3/174 (1.72%)  0/170 (0.00%) 
Alopecia  1  1/174 (0.57%)  0/170 (0.00%) 
Dermatitis allergic  1  0/174 (0.00%)  1/170 (0.59%) 
Drug eruption  1  1/174 (0.57%)  0/170 (0.00%) 
Hyperhidrosis  1  1/174 (0.57%)  0/170 (0.00%) 
Hyperkeratosis  1  0/174 (0.00%)  1/170 (0.59%) 
Psoriasis  1  0/174 (0.00%)  1/170 (0.59%) 
Skin hemorrhage  1  0/174 (0.00%)  1/170 (0.59%) 
Surgical and medical procedures     
Skin operation  1  1/174 (0.57%)  0/170 (0.00%) 
Tooth extraction  1  0/174 (0.00%)  1/170 (0.59%) 
Vascular disorders     
Hypertension  1  4/174 (2.30%)  3/170 (1.76%) 
Hematoma  1  3/174 (1.72%)  2/170 (1.18%) 
Hypotension  1  4/174 (2.30%)  0/170 (0.00%) 
Hypertensive crisis  1  0/174 (0.00%)  2/170 (1.18%) 
Phlebitis  1  2/174 (1.15%)  0/170 (0.00%) 
Circulatory collapse  1  0/174 (0.00%)  1/170 (0.59%) 
Thrombophlebitis  1  1/174 (0.57%)  0/170 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00911300     History of Changes
Other Study ID Numbers: 111418
First Submitted: May 28, 2009
First Posted: June 1, 2009
Results First Submitted: August 2, 2012
Results First Posted: September 5, 2012
Last Update Posted: October 1, 2012