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PREVAIL: PREvention of VTE After Acute Ischemic Stroke With LMWH Enoxaparin ( - VTE: Venous Thromboembolism - LMWH: Low Molecular Weight Heparin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00077805
Recruitment Status : Completed
First Posted : February 16, 2004
Last Update Posted : January 11, 2011
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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

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: Enoxaparin sodium Phase 4

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : August 2003
Actual Primary Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Primary Outcome Measures :
  1. Cumulative occurrence of VTE events (deep-vein thrombosis, pulmonary embolism) [ Time Frame: 10 ± 4 days following acute ischemic stroke ]

Secondary Outcome Measures :
  1. cumulative VTE events [ Time Frame: at 30-day, 60-day and 90-day ]
  2. stroke recurrence, stroke progression, National Institute of Health Stroke Scale (NIHSS) scores [ Time Frame: during treatment and follow-up periods ]
  3. Modified Rankin Scale (MRS) scores [ Time Frame: at 30-day and 90-day follow-up ]
  4. major & minor hemorrhages [ Time Frame: from the inform consent signed up to the end of the study ]
  5. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 <100,000/mm3; aPTT 1.5 X the laboratory upper limit of normal; or international normalized ratio(INR) >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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00077805

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United States, New Jersey
Bridgewater, New Jersey, United States
North Ryde, Australia
Vienna, Austria
Sao Paulo, Brazil
Laval, Canada
Bogota, Colombia
Czech Republic
Prague, Czech Republic
Mumbai, India
Natanya, Israel
Milan, Italy
Korea, Republic of
Seoul, Korea, Republic of
Mexico, Mexico
Warsaw, Poland
South Africa
Johannesburg, South Africa
Istanbul, Turkey
Sponsors and Collaborators
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Study Director: Luc Sagnard Sanofi

Publications of Results:
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Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00077805    
Other Study ID Numbers: XRP4563H_4001
First Posted: February 16, 2004    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
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Cerebral Infarction
Venous Thromboembolism
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Embolism and Thrombosis
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action