NCT00077805

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

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
14 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 16, 2004

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Last Updated

January 11, 2011

Status Verified

January 1, 2011

Enrollment Period

2.9 years

First QC Date

February 12, 2004

Last Update Submit

January 10, 2011

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • Cumulative occurrence of VTE events (deep-vein thrombosis, pulmonary embolism)

    10 ± 4 days following acute ischemic stroke

Secondary Outcomes (5)

  • cumulative VTE events

    at 30-day, 60-day and 90-day

  • stroke recurrence, stroke progression, National Institute of Health Stroke Scale (NIHSS) scores

    during treatment and follow-up periods

  • Modified Rankin Scale (MRS) scores

    at 30-day and 90-day follow-up

  • major & minor hemorrhages

    from the inform consent signed up to the end of the study

  • Treatment emergent adverse events (TEAE), serious adverse events (SAE), all-cause mortality

    from the inform consent signed up to the end of the study

Interventions

Enoxaparin sodiumDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 \[HITTS\])
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Sanofi-Aventis

Bridgewater, New Jersey, United States

Location

Sanofi-Aventis

North Ryde, Australia

Location

Sanofi-Aventis

Vienna, Austria

Location

Sanofi-Aventis

São Paulo, Brazil

Location

Sanofi-Aventis

Laval, Canada

Location

Sanofi-Aventis

Bogotá, Colombia

Location

Sanofi-Aventis

Prague, Czechia

Location

Sanofi-Aventis

Mumbai, India

Location

Sanofi-Aventis

Netanya, Israel

Location

Sanofi-Aventis

Milan, Italy

Location

Sanofi-Aventis

México, Mexico

Location

Sanofi-Aventis

Warsaw, Poland

Location

Sanofi-Aventis

Johannesburg, South Africa

Location

Sanofi-Aventis

Seoul, South Korea

Location

Sanofi-Aventis

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • Kase CS, Albers GW, Bladin C, Fieschi C, Gabbai AA, O'Riordan W, Pineo GF; PREVAIL Investigators. Neurological outcomes in patients with ischemic stroke receiving enoxaparin or heparin for venous thromboembolism prophylaxis: subanalysis of the Prevention of VTE after Acute Ischemic Stroke with LMWH (PREVAIL) study. Stroke. 2009 Nov;40(11):3532-40. doi: 10.1161/STROKEAHA.109.555003. Epub 2009 Aug 20.

    PMID: 19696423RESULT

  • Sherman DG, Albers GW, Bladin C, Fieschi C, Gabbai AA, Kase CS, O'Riordan W, Pineo GF; PREVAIL Investigators. The efficacy and safety of enoxaparin versus unfractionated heparin for the prevention of venous thromboembolism after acute ischaemic stroke (PREVAIL Study): an open-label randomised comparison. Lancet. 2007 Apr 21;369(9570):1347-1355. doi: 10.1016/S0140-6736(07)60633-3.

    PMID: 17448820RESULT

MeSH Terms

Conditions

Ischemic Stroke

Interventions

enoxaparin sodium

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Luc Sagnard

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 12, 2004

First Posted

February 16, 2004

Study Start

August 1, 2003

Primary Completion

July 1, 2006

Last Updated

January 11, 2011

Record last verified: 2011-01

Locations

ZA(1)BR(1)CZ(1)PL(1)IL(1)CO(1)KR(1)AU(1)ME(1)IN(1)US(1)TU(1)CA(1)IT(1)