prevail: prevention of vte after acute ischemic stroke with lmwh enoxaparin ( - vte: venous thromboembolism - lmwh: low molecular weight heparin)

Conditions: Acute Ischemic Stroke

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


Eligibility criteria:
inclusion criteria: * acute ischemic stroke, any territory, with an appropriate neuroradiologic study (head ct scan or brain mri scan) providing results consistent with non hemorrhagic stroke * onset of symptoms of qualifying stroke within 48 hours prior to randomization. in patients receiving thrombolytic therapy for the acute stroke, such as tissue-type plasminogen activator (tpa), administration of study drug may not start until at least 24 hours after completion of thrombolytic therapy * significant motor impairment of the leg, as indicated by a nihss score ≥2 on item 6 * inability to walk without assistance exclusion criteria: * females who are pregnant, breast-feeding, or of childbearing potential and not using medically acceptable and effective contraception * clinical evidence of vte at screening * any evidence of active bleeding on the basis of clinical judgment * prior history of intracranial hemorrhage (including that at screening) * spinal or epidural analgesia or lumbar puncture within the preceding 24 hours * thrombolytic therapy (e.g., tpa) or intra-arterial thrombolytic therapy within the preceding 24 hours.thrombolytic therapy is permitted for treatment of the acute stroke but must have been completed 24 hours prior to randomization. * comatose at screening (nihss score ≥2 on item 1a) * known or suspected cerebral aneurysm or arteriovenous malformation * confirmed malignancy that may pose an increased risk for bleeding or otherwise compromise follow-up or outcome assessment (e.g., lung cancer) * impaired hemostasis, i.e., known or suspected coagulopathy (acquired or inherited); baseline platelet count \ 1.5 * major surgery or recent major trauma within the previous 3 months * anticipated need for full-dose treatment with therapeutic levels of an anticoagulant (lmwh, ufh, oral anticoagulant), e.g., for cardiogenic source of embolism or dissection * treatment with a lmwh or ufh at prophylactic dose for more than 48 hours prior to randomization(patients receiving lmwh or ufh less than 48 hours prior to randomization may be randomized) * allergy to heparin or enoxaparin sodium, or known hypersensitivity to heparin, enoxaparin, or pork products * history of heparin or enoxaparin induced thrombocytopenia and/or thrombosis (heparin-induced thrombocytopenia \[hit\], heparin-associated thrombocytopenia \[hat\], or heparin-induced thrombotic thrombocytopenia syndrome \[hitts\]) * history of hypersensitivity to iodinated contrast media and/or iodine * bacterial endocarditis * prosthetic heart valve * known or suspected severe anemia (hg \<10.0 g/dl) * uncontrolled arterial hypertension (systolic blood pressure \[bp\] \>180 mmhg or diastolic bp \>100 mmhg) at the time of randomization or clinical hypertensive urgency * any other clinically relevant serious diseases, including severe liver disease or renal failure \[creatinine clearance \<30 ml/min on at least two occasions\]. * treatment with other investigational agents or devices within the previous 30 days, planned use of other investigational drugs or devices, or previous enrollment in this study.