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

January 10, 2011 updated by: Sanofi

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • North Ryde, Australia
        • Sanofi-Aventis
  • Austria
      • Vienna, Austria
        • Sanofi-Aventis
  • Brazil
      • Sao Paulo, Brazil
        • Sanofi-Aventis
  • Canada
      • Laval, Canada
        • Sanofi-Aventis
  • Colombia
      • Bogota, Colombia
        • Sanofi-Aventis
  • Czech Republic
      • Prague, Czech Republic
        • Sanofi-Aventis
  • India
      • Mumbai, India
        • Sanofi-Aventis
  • Israel
      • Natanya, Israel
        • Sanofi-Aventis
  • Italy
      • Milan, Italy
        • Sanofi-Aventis
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Sanofi-Aventis
  • Mexico
      • Mexico, Mexico
        • Sanofi-Aventis
  • Poland
      • Warsaw, Poland
        • Sanofi-Aventis
  • South Africa
      • Johannesburg, South Africa
        • Sanofi-Aventis
  • Turkey
      • Istanbul, Turkey
        • Sanofi-Aventis
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative occurrence of VTE events (deep-vein thrombosis, pulmonary embolism)
Time Frame: 10 ± 4 days following acute ischemic stroke
10 ± 4 days following acute ischemic stroke

Secondary Outcome Measures

Outcome Measure
Time Frame
cumulative VTE events
Time Frame: at 30-day, 60-day and 90-day
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
during treatment and follow-up periods
Modified Rankin Scale (MRS) scores
Time Frame: at 30-day and 90-day follow-up
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
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
from the inform consent signed up to the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Luc Sagnard, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

February 12, 2004

First Submitted That Met QC Criteria

February 13, 2004

First Posted (Estimate)

February 16, 2004

Study Record Updates

Last Update Posted (Estimate)

January 11, 2011

Last Update Submitted That Met QC Criteria

January 10, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XRP4563H_4001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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