ACTION - Anticoagulation Treatment Influence on Post-operative Patients
This study has been withdrawn prior to enrollment.
(Study replaced by an observational study)
Sponsor:
St. Jude Medical
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00187304
First received: September 15, 2005
Last updated: June 4, 2013
Last verified: June 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Valve Disease |
Device: Aortic valve replacement |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Anticoagulation Treatment Influence on Post-operative Patients -Action SJM EPIC Trial |
Resource links provided by NLM:
Further study details as provided by St. Jude Medical:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | St. Jude Medical |
| ClinicalTrials.gov Identifier: | NCT00187304 History of Changes |
| Other Study ID Numbers: | CS04012TV |
| Study First Received: | September 15, 2005 |
| Last Updated: | June 4, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Heart Valve Diseases Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 13, 2013