Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by (Responsible Party):	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00679588

Purpose

The primary objective of the study was to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of AVE5026 with q.d. s.c. injections of Enoxaparin for the prevention of Venous Thromboembolic Events (VTE) in patients undergoing major abdominal surgery.

The secondary objectives were to evaluate the safety of AVE5026 and to document AVE5026 exposure in this population.

Condition	Intervention	Phase
Venous Thromboembolism	Drug: Semuloparin Sodium (AVE5026) Drug: Enoxaparin Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Multinational, Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of AVE5026 With Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

Resource links provided by NLM:

Drug Information available for: Enoxaparin Sodium

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Occurence of the composite endpoint of any VTE confirmed by a blinded Central Independent Adjudication Committee (CIAC) and deaths from any cause [ Time Frame: From randomization up to Day 11 or the day of mandatory venography, whichever comes first ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurence of the composite endpoint of any proximal Deep Vein Thrombosis (DVT), symptomatic distal DVT, non-fatal Pulmonary Embolism (PE), and all cause deaths [ Time Frame: From randomization up to Day 11 or the day of mandatory venography, whichever comes first ] [ Designated as safety issue: No ]
Number of patients with major bleedings and clinically relevant non-major bleedings as confirmed by the CIAC [ Time Frame: Up to a maximum of 42 days ] [ Designated as safety issue: Yes ]
Number of patients requiring the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment [ Time Frame: Up to a maximum of 42 days ] [ Designated as safety issue: No ]

Enrollment:	4413
Study Start Date:	April 2008
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AVE5026 AVE5026, once daily starting 8 hours after surgery. Matching placebo, before surgery according to Enoxaparin local labeling then 12 hours after surgery. AVE5026 dose was reduced in patients with severe renal impairment.	Drug: Semuloparin Sodium (AVE5026) Form: solution in ready-to-use prefilled syringe Route: subcutaneous injection Drug: Placebo Form: solution in ready-to-use prefilled syringe Route: subcutaneous injection
Active Comparator: Enoxaparin Enoxaparin, 40 mg once daily starting before surgery according to Enoxaparin local labeling then 12 hours after surgery. Matching placebo, 8 hours after surgery. Enoxaparin dose was reduced to 20 mg in patients with severe renal impairment.	Drug: Enoxaparin Form: solution in ready-to-use prefilled syringe Route: subcutaneous injection Drug: Placebo Form: solution in ready-to-use prefilled syringe Route: subcutaneous injection

Detailed Description:

The total duration of observation per patient was 35 - 42 days from surgery, and included:

a double-blind treatment period of 7 - 10 days,
a follow-up period of 28 - 35 days.

A mandatory bilateral venography was to be performed 7 to 11 days after surgery.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients undergoing major surgery of the abdomen and/or the pelvis.
Patients <60 years with one of the following additional risk factors:
- History of venous thromboembolism,
- Obesity,
- Chronic Heart failure,
- Chronic Respiratory Failure,
- Inflammatory Bowel Disease,
- Cancer Surgery.

Exclusion Criteria:

Any major orthopedic or general surgery in the 3 months prior to study start.
Clinical signs or symptoms of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) within the last 12 months or known post phlebitic syndrome.
Any contra-indications to the performance of venography.
Patients at high risk of bleeding.
Known hypersensitivity to heparin or Enoxaparin sodium.

The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679588

Show 270 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Principal Investigator:	Ajay Kakkar, Prof., MD, PhD	Queen Mary's School of Medicine & Dentistry, London (UK)
Study Chair:	Alexander Turpie, MD	HHS-General Hospital, Hamilton, Canada

More Information

No publications provided

Responsible Party:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00679588 History of Changes
Other Study ID Numbers:	EFC6520, 2007-007942-36
Study First Received:	May 7, 2008
Last Updated:	January 4, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Digestive System Surgical Procedure
Urologic Surgical Procedure
Prevention of venous thromboembolism
Abdominal surgery

Additional relevant MeSH terms:

Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Enoxaparin
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 09, 2012