Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: Anticoagulants; Aspirin; Salicylates; Salicylic Acid; Warfarin

Criteria

Inclusion criteria:

• Patients with aortic valve disease where there is indication for implantation of a biological stented aortic valve with or without coronary bypass surgery.

• Age 60 years Sinus rhythm

Exclusion Criteria:

• Patients planned for double valve surgery

• Patients with active endocarditis

• Patients with atrial fibrillation/flutter

• Patients in anticoagulation treatment of other reason.

• Patients with previous cerebrovascular accidents or insults.

• Patients with TCI

• Patients with hypercoagulable conditions, disseminated intervascular coagulation, haemophilia or any other blood coagulapathy or related condition, whereby the blood coagulation process is not readily controllable

• Patients with pacemaker

• Any other disease than valve disease that will considerably increase the operative risk and increase the probability that the patient dies within one year after the operation, for example because of terminal cancer

• Patients that is HIV-positive or have active AIDS

• Patients that are known drug abuser

• Patients in chronic haemodialysis or other types of dialysis