drugset / Trial / NCT01452568

Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin

NCT01452568

Phase 4 Completed 370 enrolled Rigshospitalet, Denmark
RandomizedParallel-groupOpen-labelTreatment

Summary

The optimal medical strategy for prevention of thromboembolic events after bioprosthetic aorta valve replacement (BAVR) remains controversial. The aim of this trial was to compare warfarin therapy (target INR of 2.0 to 3.0) against aspirin 150mg daily as antithrombotic therapy for the first three months after BAVR with or without concomitant coronary artery bypass grafting (CABG). The aim was to evaluate thromboembolic complications, bleeding complications and death.

Timeline

Start
2005-06
Primary completion
2012-03
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 150 mg
Comparator Warfarin Small molecule