Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin

Rigshospitalet

Status and phase

Completed

Phase 4

Conditions

Thromboembolism

Bleeding

Treatments

Drug: Warfarin

Drug: Aspirin

Study type

Interventional

Funder types

Other

Identifiers

NCT01452568

(KF) 01-080/04 (Other Identifier)

01-080/04

Details and patient eligibility

About

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.

Enrollment

370 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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