- 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.
- 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
- Enoxaparin (Lovenox®)Drug
Intervention Desc: Low-molecular-weight heparin.
- Heparin (acute stroke) Drug
Intervention Desc: Intravenous anticoagulant.
- Enoxaparin sodium Drug
- Allocation: Randomized
- Masking: Open Label
- Purpose: Prevention
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Patients were randomized to receive enoxaparin daily 40 mg SC or UFH 5000 IU SC Q 12 treatment for 10 days +/- 4 days with a follow up period of 90 days and stratified by NIH Stroke Scale Score (severe greater than or equal to 14 and less severe <14).
|Type||Measure||Time Frame||Safety Issue|
|Primary||Composite of symptomatic or asymptomatic deep-vein thrombosis (DVT), and/or symptomatic or fatal pulmonary embolism (PE) during the treatment period. Primary safety endpoints were symptomatic intracranial bleeding, major extracranial bleeding and all-cause mortality.|
|Secondary||Incidence of VTE, incidence of stroke recurrence, rate of stroke progression, patient functional status, safety of using enoxaparin compared to UFH.|
|Primary||Cumulative occurrence of VTE events (deep-vein thrombosis, pulmonary embolism)||10 ± 4 days following acute ischemic stroke||No|
|Secondary||cumulative VTE events||at 30-day, 60-day and 90-day||No|
|Secondary||stroke recurrence, stroke progression, National Institute of Health Stroke Scale (NIHSS) scores||during treatment and follow-up periods||No|
|Secondary||Modified Rankin Scale (MRS) scores||at 30-day and 90-day follow-up||No|
|Secondary||major & minor hemorrhages||from the inform consent signed up to the end of the study||No|
|Secondary||Treatment emergent adverse events (TEAE), serious adverse events (SAE), all-cause mortality||from the inform consent signed up to the end of the study||No|
- Sanofi-Aventis Lead