Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Venous Thromboembolism
Intervention: AVE5026 (Drug); Enoxaparin (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Patrick Mismetti, MD, Principal Investigator, Affiliation: University Hospital of Saint-Etienne, France
Alexander Turpie, MD, Study Chair, Affiliation: HHS-General Hospital, Hamilton, Canada
Overall contact:
Public registry ICD, Email: GV-Contact-us@sanofi-aventis.com
Summary
The primary objective of this study is to compare the efficacy of AVE5026 with enoxaparin
for the primary prevention of venous thromboembolic events (VTE) in patients hospitalized for
acute medical illness.
The secondary objectives of this study are to evaluate the safety of AVE5026 and to document
AVE5026 exposures in this population.
Clinical Details
Official title: A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 With Enoxaparin for the Primary Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Composite of any asymptomatic proximal Deep Vein Thrombosis, any confirmed VTE and any VTE-related deaths (fatal Pulmonary Embolism or unexplained death)
Secondary outcome: Each component of the primary efficacy endpoint up to Day 15 or up to the day of the mandatory CUS (whichever comes first)Bleeding events, transfusions, laboratory data, adverse events, deaths
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient with an acute medical condition requiring bed rest for at least 3 days
- Hospitalized for at least one of the following medical conditions:
- Congestive heart failure (NYHA class III/IV)
- Acute respiratory failure (not requiring mechanical ventilation)
- Acute infection (without septic shock)*
- Acute rheumatic disorder*
- Acute episode of inflammatory bowel disease*
*Patients with these conditions should have at least one additional risk factor
for VTE among the following:
- Active cancer or myeloproliferative disorders (having received treatment for
cancer within the last 6 months)
- Previous VTE
- Obesity
- Oral hormone therapy (antiandrogen or estrogen)
- Chronic heart failure
- Chronic respiratory failure
Exclusion Criteria:
- Previous surgery with general anesthesia within 30 days before inclusion in the study
- Patient requiring a curative anticoagulant or thrombolytic treatment
- Patient at risk of bleeding
- Stroke
- Known hypersensitivity to heparin or enoxaparin sodium
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
Locations and Contacts
Public registry ICD, Email: GV-Contact-us@sanofi-aventis.com
Sanofi-Aventis Administrative Office, Seoul, Korea, Republic of; Recruiting
Email: GV-Contact-us@sanofi-aventis.com
Sanofi-Aventis Administrative Office, Bridgewater, New Jersey 08807, United States; Recruiting
Email: GV-Contact-us@sanofi-aventis.com
Additional Information
Starting date: July 2008
Ending date: March 2011
Last updated: October 24, 2008
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