Safety Study of Fondaparinux Sodium to Prevent Venous Thromboembolic Events (APOLLO) - Full Text View

Sponsor:	GlaxoSmithKline
Collaborators:	Sanofi-Aventis Organon
Information provided by (Responsible Party):	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00038961

Purpose

This study is a randomized, double-blind, deep vein thrombosis (DVT) prevention trial in patients undergoing major abdominal surgery in 80 U.S. centers. All patients receive background treatment of intermittent pneumatic compression devices. All subjects are assessed for DVTs with bilateral venography at the end of the study drug treatment period (day 5-9).

Condition	Intervention	Phase
Venous Thrombosis Surgery Deep Vein Thrombosis Pulmonary Embolism Venous Thromboembolism Abdominal Surgery	Drug: Fondaparinux Sodium Other: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-blind, Parallel Group Trial to Demonstrate the Efficacy of Fondaparinux Sodium in Association With Intermittent Pneumatic Compression Versus Intermittent Pneumatic Compression Used Alone for the Prevention of Venous Thromboembolic Events in Patients at Increased Risk Undergoing Major Abdominal Surgery

Resource links provided by NLM:

MedlinePlus related topics: Deep Vein Thrombosis Pulmonary Embolism

Drug Information available for: ORG 31540 Fondaparinux sodium

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

venous thromboembolism (VTE [ Time Frame: adjudicated mandatory venogram positive for DVT between day 5 and day 10; up to day 10 for symptomatic DVT and/or adjudicated non fatal Pe , adjudicated fatal PE ] [ Designated as safety issue: No ]
the incidence of VTE determined as any of the following VTE outcomes recorded up to the first venogram performed or up to Day 10, whichever occurred first: adjudicated manadatory veongram positive for DVT between Day 5 and Day 10; adjudicated symptomatic DVT and/or adjudicated non-fatal PE; adjudicated fatal PE
major bleeding [ Time Frame: first study drug injection to 2 days after last study drug injection and first study drug injection up to Day 32 ] [ Designated as safety issue: No ]
adjudicated major bleeding

Secondary Outcome Measures:

deep vein thrombosis (DVT) [ Time Frame: up to Day 10 ] [ Designated as safety issue: No ]
Incidence of any DVT, any proximal DVT, and distal only DVT
symptomatic VTE (venous thromboembolism) [ Time Frame: up to Day 10 and up to Day 32 ] [ Designated as safety issue: No ]
Incidence of adjudicated symptomatic VTE (DVT, non fatal pulmonary embolism (PE), and fatal PE
initiation of curative treatment [ Time Frame: study period ] [ Designated as safety issue: No ]
Initiation of curative treatment after VTE assessment used for the primary endpoint evaluation
any VTE and all deaths [ Time Frame: up to Day 10 ] [ Designated as safety issue: No ]
incidence of any VTE and all deaths
symptomatic VTE and all deaths [ Time Frame: up to Day 32 ] [ Designated as safety issue: No ]
incidence of adjudicated symptomatic VTE and all deaths
minor bleeding [ Time Frame: treatment period and up to day 32 ] [ Designated as safety issue: Yes ]
adjudicated minor bleeding
All major or minor bleeding [ Time Frame: study period ] [ Designated as safety issue: Yes ]
All adjudicated (major or minor) bleeding
Adverse events [ Time Frame: study period ] [ Designated as safety issue: Yes ]
Adverse Events (AEs/serious adverse events (SAEs))
Transfusion [ Time Frame: study period ] [ Designated as safety issue: Yes ]
the need for transfusion and total blood units transfused
Lab parameters [ Time Frame: study period ] [ Designated as safety issue: Yes ]
changes from baseline in laboratory parameters
Death [ Time Frame: study period ] [ Designated as safety issue: Yes ]
Death

Enrollment:	1309
Study Start Date:	October 2001
Study Completion Date:	October 2004
Primary Completion Date:	October 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: fondaparinux + intermittent pneumatic compression (IPC) fondaparinux + intermittent pneumatic compression (IPC)	Drug: Fondaparinux Sodium 2.5 mg fondparinux sodium, daily, s.c. starting 6 to 8 hours after surgical closure for up to 7 +/- 2 days, administered on top of IPC +/- elastic stockings (ES)
Placebo Comparator: Placebo + intermittent pneumatic compression (IPC) Placebo + intermittent pneumatic compression (IPC)	Other: Placebo placebo, daily, s.c. starting 6 to 8 hours after surgical closure for up to 7 +/- 2 days, administered on top of IPC +/- elastic stockings (ES)

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Undergoing abdominal surgery (any surgery between the diaphragm and pelvic floor) lasting longer than 45 minutes (duration from anesthesia induction to surgical closure)
Over 40 years of age

Inclusion Criteria:

Undergoing abdominal surgery (any surgery between the diaphragm and pelvic floor) lasting longer than 45 minutes (duration from anesthesia induction to surgical closure)
Over 40 years of age
Subject who had signed the informed consent.

Exclusion Criteria:

Active, clinically significant bleeding
Documented congenital or acquired bleeding tendency/disorders
Active ulcerative gastrointestinal disease unless the reason for the present surgery.
Recent intracranial hemorrhage or recent (less than 3 months prior to randomisation) brain, spinal, or ophthalmologic surgery.
Indwelling intrathecal or epidural catheters for more than 6 hours after surgical closure.
Subjects who had a traumatic puncture or unusual difficulty in applying the catheter
Known cerebral metastasis,
Subjects in whom hemostasis had not been established 6 hours after surgical closure,
Current thrombocytopenia,
Bacterial endocarditis
Creatinine level above 2.0 mg/dL (180 μmol/L) in a well-hydrated subject,
Documented hypersensitivity to contrast media,
Use of any contraindicated drug that could not be combined with the injection of contrast medium,
Patent with evidence of leg ischemia caused by peripheral vascular disease, unable to undergo IPC and unable to wear Elastic Stockings.

Exclusion criteria related to trial methodology:

Mental disorders that could interfere with study participation and/or failure to give written informed consent to take part in the study,
Subject's life expectancy < 6 months,
Clinical sign of DVT and/or history of recent DVT,
Participation in any other therapeutic drug study or a device study evaluating DVT prophylaxis within 90 days preceding inclusion,
Previous participation in a study of fondaparinux sodium,
Known hypersensitivity to fondaparinux and its excipients,
Current addictive disorders that could interfere with study participation,
Administration of heparin, heparinoids, LMWH, oral anticoagulants, dextrans, hirudin, fibrinolytic agents or drugs blocking glycoprotein platelet receptors (GPIIb-IIIa) during the screening period, i.e., from admission to surgery,
Subjects for whom anticoagulant therapy was contraindicated or who had, due to concomitant disease, an indication for oral anticoagulant or heparins (including LMWH) and who could not discontinue those treatments,
Women of child-bearing potential: women not using an appropriate contraceptive method during the whole duration of study participation ,
Subject with body weight <50 kg,
Subjects, who in the opinion of the investigator, required a pharmacological prophylaxis in addition to intermittent pneumatic compression,
Known pregnancy and / or women who intended to breastfeed,
Subjects undergoing vascular surgery such as aorto-femoral bypass graft

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038961

Show 31 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Sanofi-Aventis

Organon

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00038961 History of Changes
Other Study ID Numbers:	103414, EFC3558, ARIXTRA, ORG31540
Study First Received:	June 5, 2002
Last Updated:	August 22, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

DVT Prevention
Major Abdominal Surgery
Venous Thromboembolic
fondaparinux sodium

abdominal surgery
VTE prevention
venous thromboembolism
pulmonary embolism

Additional relevant MeSH terms:

Embolism
Pulmonary Embolism
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

Fondaparinux
PENTA
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 12, 2012