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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00077805
First received: February 12, 2004
Last updated: January 10, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Acute Ischemic Stroke
Drug: Enoxaparin sodium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Cumulative occurrence of VTE events (deep-vein thrombosis, pulmonary embolism) [ Time Frame: 10 ± 4 days following acute ischemic stroke ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cumulative VTE events [ Time Frame: at 30-day, 60-day and 90-day ] [ Designated as safety issue: No ]
  • stroke recurrence, stroke progression, National Institute of Health Stroke Scale (NIHSS) scores [ Time Frame: during treatment and follow-up periods ] [ Designated as safety issue: No ]
  • Modified Rankin Scale (MRS) scores [ Time Frame: at 30-day and 90-day follow-up ] [ Designated as safety issue: No ]
  • major & minor hemorrhages [ Time Frame: from the inform consent signed up to the end of the study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Study Start Date: August 2003
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 <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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077805

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

Publications:
Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00077805     History of Changes
Other Study ID Numbers: XRP4563H_4001
Study First Received: February 12, 2004
Last Updated: January 10, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cerebral Infarction
Ischemia
Stroke
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Embolism and Thrombosis
Nervous System Diseases
Pathologic Processes
Thrombosis
Vascular Diseases
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014