Biological Aortic Valve Replacement Circulatory System Heart valve replacement
Conditions
Interventions
Patients will receive a specific regimen of therapy according to the result of randomisation. The administration of Low Molecular Weight Heparin (LMWH) will start on the first postoperative day, where
range 2.0 to 3.0). Anticoagulation with warfarin will be maintained for 3 postoperative months, then will be discontinued and substituted with ASA. Those with concomitant coronary artery bypass grafti
Sponsors
University of Parma (Italy)
Eligibility
Inclusion criteria
Inclusion criteria: This is a prospective randomised multicenter trial using patients who will be consecutively admitted to Cardiac Surgery Units. All patients undergoing Biological Aortic Valve Replacement (BAVR) with a St Jude Epic prosthesis and in sinus rhythm before the operation will be considered to participate to the study. The patients, after the operation, will be randomised to each group immediately before starting the specific aspirin (Acetylsalicylic Acid [ASA]) or warfarin therapy.
Exclusion criteria
Exclusion criteria: The patients with the following characteristics will be excluded: 1. History of cerebral ischaemia 2. Coagulopathy 3. Carotid atherosclerotic disease (stenosis greater than 50%, soft and ulcerated plaque) 4. Peripheral vascular disease 5. Concomitant mitral valve disease 6. Double valve replacement 7. Previous chronic anticoagulation therapy 8. Allergies to ASA or warfarin 9. Comparison of atrial fibrillation (AF) at any time during the study except for transient episode during the hospitalisation 10. Promptly cardioverted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
Italy
Outcome results
None listed