Comparing Warfarin to Aspirin after tissue valve replacement with Epic prosthesis in the aortic position: multicenter randomised trial
- Conditions
- Biological Aortic Valve ReplacementCirculatory SystemHeart valve replacement
- Registration Number
- ISRCTN99307171
- Lead Sponsor
- niversity of Parma (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ot provided at time of registration
- Secondary Outcome Measures
Name Time Method ot provided at time of registration