DVT Study
The hypothesis for this study is that, in patients with acute ischemic stroke, prophylactic treatment with enoxaparin, initiated within 48 hours following the onset of stroke symptoms, is more effective than UFH in preventing VTE. The study is designed to demonstrate the superiority of enoxaparin over UFH in the prevention of VTE as well as to demonstrate that enoxaparin is as safe as UFH in patients following acute ischemic stroke.
Inclusion criteria
- Acute ischemic stroke, any territory, with an appropriate neuroradiologic study (head CT or brain MRI scan)
- Onset of symptoms of the qualifying stroke within 24 hours prior to randomization for those patients not receiving thrombolytic agents (tPA), and 48 hours for those who have received thrombolytic agents.
- Significant motor impairment of the leg, as indicated by a NIHSS score >/= 2 on item 6
- Unable to walk
Exclusion criteria
- Females pregnant, breastfeeding or of childbearing potential not using medically acceptable contraceptive
- Clinical evidence of VTE at screening
- Any evidence of bleeding
- Prior intracranial hemorrhage
- Treatment wit tPA within prior 24 hours
- Intra-arterial tPA
- Comatose at screening
- Known or suspected anuerysm or arteriovenous malformation
- Confirmed malignancy
- Impaired hemostasis
- Major surgery or recent major trauma w/in 3 months
- Anticipated need for full-dose treatment for levels of an anticoagulant
- Treatment with heparin for more than 48 hours prior to inclusion
- History of hypersensitivity to iodinated contrast media and/or iodine
- Bacterial endocarditis
- Prosthetic heart valve
- Known or suspected severe anemia
- Uncontrolled arterial hypertension at the time of randomization
- Chronic renal failure
- Life expectancy of less than 3 months
- Participation in another study or treatment with other investigational agents or devices w/in previous 30 days
- Is unlikely to be compliant with requirements
For questions or information regarding stroke, the Stanford Stroke Center, or participation in current clinical trials please send e-mail to . (Please note: individual patient treatment advice cannot be given). You can call (650) 723-6469 to make a referral.
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