Completed

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

What is being tested

Data Collection

Who is being recruted

Ischemic Stroke+5

+ Brain Diseases

+ Cardiovascular Diseases

Over 18 Years

+26 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 4

Interventional

Study Start: August 2003

See protocol details

Summary

Principal SponsorSanofi

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2003

Actual date on which the first participant was enrolled.

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

Official TitleAn 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

NCT00077805

Principal SponsorSanofi

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Ischemic StrokeBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesVascular DiseasesStroke

Criteria

4 inclusion criteria required to participate

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

22 exclusion criteria prevent from participating

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)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 15 locations

Suspended

Sanofi-Aventis

Bridgewater, United StatesOpen Sanofi-Aventis in Google Maps

Suspended

Sanofi-Aventis

North Ryde, Australia

Suspended

Sanofi-Aventis

Vienna, Austria

Suspended

Sanofi-Aventis

São Paulo, Brazil

Completed15 Study Centers