ACTION - Anticoagulation Treatment Influence on Post-operative Patients
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ClinicalTrials.gov Identifier: NCT00187304
Recruitment Status :
(Study replaced by an observational study)
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™ Supra Porcine Bioprosthetic Heart Valve by establishing the adverse event free survival rate at 3 month post intervention follow-up of the 2 groups(with special focus on thromboembolic events and bleedings).
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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