Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Early Anticoagulation Therapy After Bioprosthetic Aortic Valve Implantation: Comparing Warfarin Versus Aspirin|
- Haemorrhagic complications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Bleeding complications
- Thromboembolic complications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]TCI, stroke, Myocardial infarction (MI), Pulmonary embolism, Deep vein thrombosis (DVT) , peripheral arterial embolism, intra-cardiac thrombus formation. We expected statistically fewer thromboembolic events in the groups receiving anticoagulation with warfarin than the aspirin only groups.
- Echocardiographic findings before surgery, before discharge and 3 months after implantation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Registration of surgical data and postoperative complications [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- All cause mortality [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2005|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Aspirin 150mg daily, starting day 1 after surgery, for three months.
150mg/daily for three months, starting day after surgery
Other Name: Magnyl, Acetyl salicylic acid
Active Comparator: Warfarin
Warfarin daily dosage to International normalized ratio(INR) value between 2,0 to 3,0.
Warfarin daily dosage to obtain an INR in between 2,0 to 3,0. Started the day after surgery and continued for three months.
Other Name: marevan
Please refer to this study by its ClinicalTrials.gov identifier: NCT01452568
|Principal Investigator:||Peter S Olsen, MD, DMSc||Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen|
|Principal Investigator:||Nikolaj B Lilleør||Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen|
|Study Chair:||Sulman Rafiq||Cardiothoracic Surgery, Rigshospitalet, University of Copenhagen|