Prophylaxis of thrombotic and embolic events in acute ischemic stroke with the low-molecular-weight heparin certoparin: results of the PROTECT Trial.

Abstract

BACKGROUND AND PURPOSE:

Patients with stroke are at substantial risk of thromboembolic complications and therefore require antithrombotic prophylaxis. To show the noninferiority of the low-molecular-weight heparin certoparin to unfractionated heparin (UFH) for the prevention of thromboembolic complications, we performed a randomized, double-blind, active-controlled multicenter trial in patients with acute ischemic stroke.

METHODS:

Overall, 545 patients were randomized within 24 hours of stroke onset to treatment with certoparin (3000 U anti-Xa OD; n=272) or UFH (5000 U TID; n=273) for 12 to 16 days. Patients with paresis of a leg and an National Institutes of Health Stroke Scale score of 4 to 30 points were included. The primary end point was a composite outcome of proximal deep vein thrombosis, pulmonary embolism, or death related to venous thromboembolism during treatment. Computed tomography was performed at trial entry, after 7 days, and when clinical deterioration occurred.

RESULTS:

The per-protocol analysis revealed 17 (7.0%) primary events in the certoparin group compared with 24 (9.7%) in the UFH group, thereby demonstrating noninferiority (P=0.0011), confirmed by intention-to-treat analysis (6.6% versus 8.8%; P=0.008). Major bleeding occurred during treatment in 3 patients allocated to certoparin (1.1%) and 5 patients allocated to UFH (1.8%).

CONCLUSIONS:

Certoparin (3000 U anti-Xa OD) is at least as effective and safe as UFH (TID) for the prevention of thromboembolic complications in patients with acute ischemic stroke.

• Authors: Hans-Christoph Diener, Erich B Ringelstein, Rüdiger von Kummer, Helmut Landgraf, Klaus Koppenhagen, Job Harenberg, Ivan Rektor, Attila Csányi, Dietmar Schneider, Jürgen Klingelhöfer, Joachim Brom, Gottfried Weidinger, PROTECT Trial Group
• Journal: Stroke (Stroke) Vol. 37 Issue 1 Pg. 139-44 (Jan 2006) ISSN: 1524-4628 [Electronic] United States
• PMID: 16306456 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Heparin, Low-Molecular-Weight
• Heparin
• certoparin

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Double-Blind Method
• Heparin (therapeutic use)
• Heparin, Low-Molecular-Weight (therapeutic use)
• Humans
• Ischemia (therapy)
• Middle Aged
• Models, Statistical
• Pulmonary Embolism (drug therapy, mortality)
• Risk
• Severity of Illness Index
• Stroke (drug therapy, mortality, pathology)
• Thromboembolism (drug therapy, mortality, pathology)
• Time Factors
• Tomography, X-Ray Computed
• Treatment Outcome
• Venous Thrombosis (drug therapy)