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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Sanofi-Aventis
Bridgewater, New Jersey, United States
Sanofi-Aventis
North Ryde, Australia
Sanofi-Aventis
Vienna, Austria
Cumulative occurrence of VTE events (deep-vein thrombosis, pulmonary embolism)
Time frame: 10 ± 4 days following acute ischemic stroke
cumulative VTE events
Time frame: at 30-day, 60-day and 90-day
stroke recurrence, stroke progression, National Institute of Health Stroke Scale (NIHSS) scores
Time frame: during treatment and follow-up periods
Modified Rankin Scale (MRS) scores
Time frame: at 30-day and 90-day follow-up
major & minor hemorrhages
Time frame: from the inform consent signed up to the end of the study
Treatment emergent adverse events (TEAE), serious adverse events (SAE), all-cause mortality
Time frame: from the inform consent signed up to the end of the study
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