Enoxaparin vs heparin for prevention of deep-vein thrombosis in acute ischaemic stroke: a randomized, double-blind study.

Completed

Phase N/A Results

Trial Description

To compare the use of enoxaprin with unfractionated heparin (UFH)in terms of their efficacy, safety, and overall risk forthromboprophylaxis in patients with acute ischemicstroke.

Interventions

Trial Design

Multicenter, double-blind, randomized study.

Patient Involvement

Patients were randomized to treatment with either enoxaparin40 mg once daily followed by two placebo injectionsat 8-hourly intervals, or UFH 5000 IU three times daily.

Outcomes

Type Measure Time Frame Safety Issue
Primary Bilateral phlebography was used to detect DVT at day 10 +/- 2 (or the end of treatment) with diagnosis confirmed by independent blinded review.
Secondary To evaluate the overall profile of the two thromboprophylactic regimens, the rates of treatment failure (based on both efficacy and safety criteria) were compared.

Sponsors

Aventis Pharma Antony, France