Clinical trial NCT00714597: Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients With Restricted Mobility
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: Venous thrombosis
Primary prevention
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-07-14
Enrollment: 421
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective was to compare the efficacy of once daily \[q.d\] subcutaneous \[s.c.\] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the primary prevention of Venous Thromboembolic Events \[VTE\] in patients hospitalized for acute medical illness.

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

Detailed description: Randomization had to take place just prior to the first study drug injection.

The total duration of observation per participant was 35-42 days from randomization broken down as follows:

* 10 to 14-day double-blind treatment period;
* 25 to 32-day follow-up period.

Mandatory bilateral compression ultrasound \[CUS\] had to be performed between 10 to 15 days after randomization.

Eligibility criteria: Inclusion Criteria:

Patient with an acute medical condition requiring bed rest for at least 3 days, and hospitalized for at least one of the following medical conditions:

* Congestive heart failure (New York Heart Association \[NYHA\] class III/IV);
* Acute respiratory failure (not requiring mechanical ventilation);
* Acute infection (without septic shock)\*;
* Acute rheumatic disorder\*;
* Acute episode of inflammatory bowel disease\*.

  * Patient with one of these conditions should have at least one additional risk factor for venous thromboembolism (VTE) among the following:

    * Age ≥ 75 years;
    * 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;
* End stage renal disease or patient on dialysis.

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

Primary outcomes:
measure: Percentage of Participants Who Experienced Venous Thromboembolism Event (VTE) or VTE-related Death
timeFrame: From randomization up to 15 days after randomization or the day of the mandatory Compression Ultrasound (CUS), whichever came first
Secondary outcomes:
measure: Percentage of Participants Who Experienced asymptomatic proximal DVT
timeFrame: From randomization up to 15 days after randomization or the day of the mandatory CUS, whichever came first.
measure: Percentage of Participants Who Experienced Clinically Relevant Bleedings
timeFrame: From 1st study drug injection up to 3 days after last study drug injection
measure: Percentage of Participants Who Required the Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment
timeFrame: From randomization up to 15 days after randomization or the day of mandatory CUS, whichever came first
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Macquarie Park
country: Australia
facility: sanofi-aventis Australia & New Zealand administrative office
state: New South Wales
city: Wien
country: Austria
facility: Sanofi-Aventis Administrative Office
city: Laval
country: Canada
facility: Sanofi-Aventis Administrative Office
city: Praha
country: Czech Republic
facility: Sanofi-Aventis Administrative Office
city: Tallinn
country: Estonia
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Berlin
country: Germany
facility: Sanofi-Aventis Administrative Office
city: Budapest
country: Hungary
facility: Sanofi-Aventis Administrative Office
city: Mumbai
country: India
facility: Sanofi-Aventis Administrative Office
city: Milano
country: Italy
facility: Sanofi-Aventis Administrative Office
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis Administrative Office
city: Riga
country: Latvia
facility: Sanofi-Aventis Administrative Office
city: Vilnius
country: Lithuania
facility: Sanofi-Aventis Administrative Office
city: Mexico
country: Mexico
facility: Sanofi-Aventis Administrative Office
city: Gouda
country: Netherlands
facility: Sanofi-Aventis Administrative Office
city: Auckland
country: New Zealand
facility: Sanofi-Aventis Administrative Office
city: Bucuresti
country: Romania
facility: Sanofi-Aventis Administrative Office
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
city: Kiev
country: Ukraine
facility: Sanofi-Aventis Administrative Office
city: Guildford Surrey
country: United Kingdom
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: University Hospital of Saint-Etienne, France
name: Patrick Mismetti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HHS-General Hospital, Hamilton, Canada
name: Alexander Turpie, MD
role: STUDY_CHAIR
References: