PREVAIL: PREvention of VTE After Acute Ischemic Stroke With LMWH Enoxaparin ( - VTE: Venous Thromboembolism - LMWH: Low Molecular Weight Heparin)
- Conditions
- Acute Ischemic Stroke
- Registration Number
- NCT00077805
- Lead Sponsor
- Sanofi
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Cumulative occurrence of VTE events (deep-vein thrombosis, pulmonary embolism) 10 ± 4 days following acute ischemic stroke
- Secondary Outcome Measures
Name Time Method cumulative VTE events at 30-day, 60-day and 90-day stroke recurrence, stroke progression, National Institute of Health Stroke Scale (NIHSS) scores during treatment and follow-up periods Modified Rankin Scale (MRS) scores at 30-day and 90-day follow-up major & minor hemorrhages from the inform consent signed up to the end of the study Treatment emergent adverse events (TEAE), serious adverse events (SAE), all-cause mortality from the inform consent signed up to the end of the study
Trial Locations
- Locations (1)
Sanofi-Aventis
🇹🇷Istanbul, Turkey