Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01452568|
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : August 5, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Thromboembolism Bleeding||Drug: Aspirin Drug: Warfarin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||370 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Anticoagulation Therapy After Bioprosthetic Aortic Valve Implantation: Comparing Warfarin Versus Aspirin|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
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
- Haemorrhagic complications [ Time Frame: 3 months ]Bleeding complications
- Thromboembolic complications [ Time Frame: 3 months ]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 ]
- Registration of surgical data and postoperative complications [ Time Frame: 3 months ]
- All cause mortality [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|