Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery (SAVE-ABDO)
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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 3 |
| 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 |
- 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 ]
- 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 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 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 |
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
Show 270 Study Locations| 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 |
| 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:
|
Digestive System Surgical Procedure Urologic Surgical Procedure Prevention of venous thromboembolism Abdominal surgery |
Additional relevant MeSH terms:
|
Thromboembolism Venous Thromboembolism Venous Thrombosis 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 May 16, 2013