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Trial record 83 of 226 for:    warfarin AND International

AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients

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ClinicalTrials.gov Identifier: NCT01780987
Recruitment Status : Completed
First Posted : January 31, 2013
Results First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Deep Vein Thrombosis
Pulmonary Embolism
Interventions Drug: Apixaban
Drug: Unfractionated Heparin (UFH)
Drug: Warfarin
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Apixaban Unfractionated Heparin (UFH)/Warfarin
Hide Arm/Group Description Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks. UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
Period Title: Overall Study
Started 40 40 [1]
Completed 37 34
Not Completed 3 6
Reason Not Completed
Adverse Event             0             4
Withdrawal by Subject             2             0
Request of Changing Hospital             0             1
Changing Residence             1             0
Not Receiving any Study Medication             0             1
[1]
Including one participant who withdrew from the study prior to receiving any study medication.
Arm/Group Title Apixaban Unfractionated Heparin (UFH)/Warfarin Total
Hide Arm/Group Description Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks. UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
All participants including one participant who was assigned to the UFH/Warfarin group and withdrew from the study prior to receiving any study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
64.3  (13.40) 66.1  (17.72) 65.2  (15.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
18
  45.0%
23
  57.5%
41
  51.2%
Male
22
  55.0%
17
  42.5%
39
  48.8%
Primary Diagnosis, Deep Venous Thrombosis (DVT)/Pulmonary Embolism (PE)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
DVT 22 23 45
PE 18 17 35
1.Primary Outcome
Title Number of Participants With Major Bleeding Events [Per International Society on Thrombosis and Homeostasis (ISTH) Definition] or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period
Hide Description Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. CRNM bleeding event was defined as an acute clinically overt bleeding that did not satisfy the definition of major bleeding and that led to either hospitalization, physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set (SAS) consisted of all treated participants.
Arm/Group Title Apixaban Unfractionated Heparin (UFH)/Warfarin
Hide Arm/Group Description:
Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
Overall Number of Participants Analyzed 40 39
Measure Type: Number
Unit of Measure: participants
3 11
2.Secondary Outcome
Title Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) [Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)] or VTE-Related Death During the Intended Treatment Period
Hide Description VTE-related death was defined as a death caused by documented PE which was diagnosed with objective testing or autopsy, or an unexplained death for which DVT/PE could not be ruled out as the cause. "Intended Treatment Period" was the period starting on the day of randomization and ending at either 2 days after the last dose of the study drug or Day 168/Week 24, whichever came late.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) was defined as all randomized participants. Participants with missing endpoint information were excluded from the analysis.
Arm/Group Title Apixaban Unfractionated Heparin (UFH)/Warfarin
Hide Arm/Group Description:
Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
Overall Number of Participants Analyzed 38 40
Measure Type: Number
Unit of Measure: participants
0 1
3.Secondary Outcome
Title Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT)
Hide Description Computed tomography venography (CTV) and compression ultrasound (CUS) were used to assess thrombotic burden in the participants with DVT and the results were classified as improved, no change, or worsened. The timings of CTV and CUS examinations were at Week 12 and Weeks 2, 12 and 24.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of full analysis set (FAS) that consisted of participants with DVT. n=number of participants evaluated.
Arm/Group Title Apixaban Unfractionated Heparin (UFH)/Warfarin
Hide Arm/Group Description:
Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
Overall Number of Participants Analyzed 22 23
Measure Type: Number
Unit of Measure: participants
CUS - Week 2 (n=22, n=22) 1 2
CTV - Week 12 (n=20, n=21) 0 0
CUS - Week 12 (n=21, n=22) 0 0
CUS - Week 24 (n=20, n=22) 0 1
4.Secondary Outcome
Title Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE)
Hide Description Computed tomography pulmonary angiography (CTPA) was used to assess thrombotic burden in the participants with PE and the results were classified as improved, no change, or worsened. The timings of CTPA examinations were Weeks 2, 12 and 24.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of full analysis set (FAS) that consisted of participants with PE. n=number of participants evaluated.
Arm/Group Title Apixaban Unfractionated Heparin (UFH)/Warfarin
Hide Arm/Group Description:
Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
Overall Number of Participants Analyzed 18 17
Measure Type: Number
Unit of Measure: participants
CTPA - Week 2 (n=18, n=17) 0 0
CTPA - Week 12 (n=18, n=16) 0 0
CTPA - Week 24 (n=16, n=15) 0 1
5.Secondary Outcome
Title Number of Participants With Adjudicated Major Bleeding Events [Per International Society on Thrombosis and Homeostasis (ISTH) Definition]During the Treatment Period
Hide Description Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set (SAS) consisted of all treated participants.
Arm/Group Title Apixaban Unfractionated Heparin (UFH)/Warfarin
Hide Arm/Group Description:
Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
Overall Number of Participants Analyzed 40 39
Measure Type: Number
Unit of Measure: participants
0 2
6.Secondary Outcome
Title Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods
Hide Description All bleeding events consisted of major bleeding (per Interactional Society on Thrombosis and Homeostasis [ISTH] Definition), clinically relevant non-major (CRNM) and minor bleeding. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRMN bleeding were classified as minor bleeding.
Time Frame Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set (SAS) consisted of all treated participants.
Arm/Group Title Apixaban Unfractionated Heparin (UFH)/Warfarin
Hide Arm/Group Description:
Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
Overall Number of Participants Analyzed 40 39
Measure Type: Number
Unit of Measure: participants
7 17
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Apixaban Unfractionated Heparin (UFH)/Warfarin
Hide Arm/Group Description Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks. UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
All-Cause Mortality
Apixaban Unfractionated Heparin (UFH)/Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Apixaban Unfractionated Heparin (UFH)/Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   3/40 (7.50%)   7/39 (17.95%) 
Blood and lymphatic system disorders     
Eosinophilia * 1  1/40 (2.50%)  0/39 (0.00%) 
Cardiac disorders     
Angina unstable * 1  0/40 (0.00%)  1/39 (2.56%) 
Infections and infestations     
Cystitis * 1  0/40 (0.00%)  1/39 (2.56%) 
Pneumonia * 1  0/40 (0.00%)  1/39 (2.56%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  0/4 (0.00%)  1/39 (2.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer * 1  1/40 (2.50%)  0/39 (0.00%) 
Colon cancer * 1  0/40 (0.00%)  1/39 (2.56%) 
Gastric cancer * 1  0/40 (0.00%)  1/39 (2.56%) 
Nervous system disorders     
Parkinsonism * 1  1/40 (2.50%)  0/39 (0.00%) 
Thalamus haemorrhage * 1  0/40 (0.00%)  1/39 (2.56%) 
Reproductive system and breast disorders     
Menorrhagia * 1  0/40 (0.00%)  1/39 (2.56%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  0/40 (0.00%)  1/39 (2.56%) 
Vascular disorders     
Deep vein thrombosis * 1  0/40 (0.00%)  1/39 (2.56%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Apixaban Unfractionated Heparin (UFH)/Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   29/40 (72.50%)   34/39 (87.18%) 
Cardiac disorders     
Atrial fibrillation * 1  0/40 (0.00%)  2/39 (5.13%) 
Palpitations * 1  2/40 (5.00%)  2/39 (5.13%) 
Gastrointestinal disorders     
Constipation * 1  5/40 (12.50%)  8/39 (20.51%) 
Diarrhoea * 1  3/40 (7.50%)  1/39 (2.56%) 
Gastrooesophageal reflux disease * 1  0/40 (0.00%)  2/39 (5.13%) 
Nausea * 1  1/40 (2.50%)  3/39 (7.69%) 
Vomiting * 1  0/40 (0.00%)  2/39 (5.13%) 
General disorders     
Pyrexia * 1  4/40 (10.00%)  5/39 (12.82%) 
Infections and infestations     
Bronchopneumonia * 1  2/40 (5.00%)  0/39 (0.00%) 
Cystitis * 1  1/40 (2.50%)  4/39 (10.26%) 
Nasopharyngitis * 1  5/40 (12.50%)  4/39 (10.26%) 
Upper respiratory tract infection * 1  3/40 (7.50%)  1/39 (2.56%) 
Urinary tract infection * 1  0/40 (0.00%)  2/39 (5.13%) 
Injury, poisoning and procedural complications     
Contusion * 1  2/40 (5.00%)  4/39 (10.26%) 
Fall * 1  4/40 (10.00%)  4/39 (10.26%) 
Investigations     
Alanine aminotransferase increased * 1  0/40 (0.00%)  3/39 (7.69%) 
Aspartate aminotransferase increased * 1  0/40 (0.00%)  3/39 (7.69%) 
Blood triglycerides increased * 1  2/40 (5.00%)  0/39 (0.00%) 
Liver function test abnormal * 1  3/40 (7.50%)  1/39 (2.56%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/40 (2.50%)  2/39 (5.13%) 
Psychiatric disorders     
Insomnia * 1  4/40 (10.00%)  4/39 (10.26%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis * 1  3/40 (7.50%)  0/39 (0.00%) 
Pulmonary embolism * 1  3/40 (7.50%)  1/39 (2.56%) 
Skin and subcutaneous tissue disorders     
Dermatitis contact * 1  3/40 (7.50%)  5/39 (12.82%) 
Haemorrhage subcutaneous * 1  1/40 (2.50%)  4/39 (10.26%) 
Pruritus * 1  0/40 (0.00%)  3/39 (7.69%) 
Vascular disorders     
Deep vein thrombosis * 1  1/40 (2.50%)  2/39 (5.13%) 
Haematoma * 1  2/40 (5.00%)  2/39 (5.13%) 
Hypertension * 1  0/40 (0.00%)  3/39 (7.69%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.0
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer Clinical Trials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01780987     History of Changes
Other Study ID Numbers: B0661024
CV185160 ( Other Identifier: BMS )
First Submitted: January 29, 2013
First Posted: January 31, 2013
Results First Submitted: January 20, 2016
Results First Posted: June 23, 2016
Last Update Posted: June 23, 2016