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PREVAIL: PREvention of VTE After Acute Ischemic Stroke With LMWH Enoxaparin ( - VTE: Venous Thromboembolism - LMWH: Low Molecular Weight Heparin)

NCT00077805 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2011-01-11

No results posted yet for this study

Summary

Primary objective:

* To demonstrate superiority of enoxaparin 40 mg sc qd in the prevention of VTE compared to UFH (unfractionated heparin) 5000 U sc q12 hours given for 10 ± 4 days following acute ischemic stroke.

Secondary objectives:

* To compare the incidence of VTE between the 2 treatment groups at 30, 60, and 90 days from the time of randomization
* To compare neurologic outcomes between the 2 treatment groups, including incidence of stroke recurrence, rate of stroke progression, and patient functional status, during the 10 ± 4 days of treatment, and after 30, 60, and 90 days from the time of randomization
* To evaluate the safety of using enoxaparin compared to UFH for VTE prevention in patients following acute ischemic stroke

Conditions

  • Acute Ischemic Stroke

Interventions

DRUG

Enoxaparin sodium

Sponsors & Collaborators

Principal Investigators

  • Luc Sagnard · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2006-07-31

Countries

  • United States
  • Australia
  • Austria
  • Brazil
  • Canada
  • Colombia
  • Czechia
  • India
  • Israel
  • Italy
  • Mexico
  • Poland
  • South Africa
  • South Korea
  • Turkey (Türkiye)

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00077805 on ClinicalTrials.gov