Trials / Completed
CompletedNCT01452568
Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin
Early Anticoagulation Therapy After Bioprosthetic Aortic Valve Implantation: Comparing Warfarin Versus Aspirin
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 370 (actual)
- Sponsor
- Rigshospitalet, Denmark · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aspirin | 150mg/daily for three months, starting day after surgery |
| DRUG | Warfarin | Warfarin daily dosage to obtain an INR in between 2,0 to 3,0. Started the day after surgery and continued for three months. |
Timeline
- Start date
- 2005-06-01
- Primary completion
- 2012-03-01
- Completion
- 2012-03-01
- First posted
- 2011-10-17
- Last updated
- 2014-08-05
Source: ClinicalTrials.gov record NCT01452568. Inclusion in this directory is not an endorsement.