Status:
WITHDRAWN
ACTION - Anticoagulation Treatment Influence on Post-operative Patients
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Valve Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to compare two different regimens of therapy, AVK and ASA (aspirin), in the early postoperative period after aortic valve replacement with SJM Epic™ or SJM Epic™...
Eligibility Criteria
Inclusion
- Patient requires, for the first time, isolated aortic valve replacement (pacemaker insertion is allowed)
- Patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements.
- Patient is of legal age in the host country
- The patient is in sinus rhythm before implantation
Exclusion
- Patient already has a prosthetic valve, other than the valve being replaced at this time.
- Patient requires double valve implantation
- Patient requires concomitant CABG
- Patients requires intra aortic balloon pump at intervention
- Patient has a medical condition which contraindicates implantation of the SJM Epic and/or SJM Epic Supra Porcine Bioprosthetic Heart Valve (e.g. patient on dialysis)
- Patient requires ASA or AVK therapy, i.e. not suitable for randomization
- Patient is pregnant or nursing.
- Patient is affected by active endocarditis.
- Patient is affected by aortic dissection.
- Patient has history of cerebral ischemia
- Patient is affected by coagulopathy, history of GI bleeding or increased bleeding risk
- Patient is affected by peripheral vascular disease requiring treatment
- Patient has previous chronic anticoagulation therapy
- Patient is allergic to ASA and/or AVK
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00187304
Start Date
September 1 2005
Last Update
February 4 2019
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