Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077805
Status:
COMPLETED
Last Update Posted:
2011-01-11
First Post:
2004-02-12
Brief Title:
PREVAIL PREvention of VTE After Acute Ischemic Stroke With LMWH Enoxaparin - VTE Venous Thromboembolism - LMWH Low Molecular Weight Heparin
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
An Open-Label Randomized Parallel-Group Multi-Center Study to Evaluate the Efficacy and Safety of Enoxaparin Versus Unfractionated Heparin in the Prevention of Venous Thromboembolism in Patients Following Acute Ischemic Stroke
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None