EXCLAIM:Extended Prophylaxis for Venous ThromboEmbolism (VTE) in Acutely Ill Medical Patients With Prolonged Immobilization

Phase 4

Completed

• Conditions: Venous Thromboembolism

• Registration Number: NCT00077753
• Lead Sponsor: Sanofi

Brief Summary

Primary objective:

* To demonstrate the superiority of extended VTE prophylaxis with enoxaparin 40mg sc qd for 28 ± 4 days, compared to placebo, both following 10 ± 4 days of initial treatment with enoxaparin 40mg sc qd

Secondary objectives:

* To assess the reduction in mortality rate at the end of the double-blind treatment period, at 3 (90 ± 10 days) and at 6 (180 ± 10 days) months from the time of entry to the study, in patients on extended prophylaxis

* To assess the incidence of VTE at 3 months (90 ± 10 days) from the time of randomization to the study

* To evaluate the safety of extended enoxaparin VTE prophylaxis in acutely ill medical patients with prolonged immobilization. Safety evaluation includes:

* Major and minor hemorrhage

* Heparin induced thrombocytopenia

* Serious adverse events

* To assess differences in levels of health-care utilization and cost between patients receiving extended VTE prophylaxis versus those receiving placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2004-02-12
• Study First Submitted QC: 2004-02-13
• Study First Posted: 2004-02-16
• Primary Completion: 2006-10
• Study Completion: 2007-02
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-10
• Last Update Posted: 2011-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4726

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
During double blind treatment : Cumulative occurrence of VTE assessed by ultrasound for all patients at 28±4 days after randomization (or earlier if symptomatic VTE) and/or V/Q lung scan for symptomatic patients ; Major hemorrhagic complications.

Secondary Outcome Measures

Name	Time	Method
Minor plus major hemorrhagic complications during Double-Blind Treatment.
Occurrence of VTE between Day 1 and Day 90±10, Mortality at the end of Double-Blind Treatment, at 3 and 6 months

Trial Locations

Locations (1)

Sanofi-Aventis; 🇬🇧 Guildford, United Kingdom