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NCT00077805 · ClinicalTrials.gov registry record · Phase 4
PREVAIL: PREvention of VTE After Acute Ischemic Stroke With LMWH Enoxaparin ( - VTE: Venous Thromboembolism - LMWH: Low Molecular Weight Heparin)
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
NCT00077805: Completed Phase 4 study, sponsored by Sanofi.
NCT00077805 is a Phase 4 study that has completed, run by Sanofi. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00077805, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
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
Interventions
- DRUG Enoxaparin sodium
Trial Details
| Field | Value |
|---|---|
| Start Date | 2003-08 |
| Phase | Phase 4 |
What the finished NCT00077805 record still lists
NCT00077805 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.
The record links to 0 conditions, and to 1 intervention - of which Enoxaparin sodium is the first listed.
NCT00077805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00077805 about?
NCT00077805 is a clinical study titled "PREVAIL: PREvention of VTE After Acute Ischemic Stroke With LMWH Enoxaparin ( - VTE: Venous Thromboembolism - LMWH: Low Molecular Weight Heparin)". 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 gr...
What is the current status of trial NCT00077805?
This trial is currently completed. It is a Phase 4 study. The study started on 2003-08.
What interventions are being tested in trial NCT00077805?
The interventions under investigation include: Enoxaparin sodium (DRUG).
Who is sponsoring clinical trial NCT00077805?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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