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ACTION - Anticoagulation Treatment Influence on Post-operative Patients

This study has been withdrawn prior to enrollment.
(Study replaced by an observational study)
Sponsor:
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

September 15, 2005
June 4, 2013
September 2005
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Complete list of historical versions of study NCT00187304 on ClinicalTrials.gov Archive Site
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ACTION - Anticoagulation Treatment Influence on Post-operative Patients
Anticoagulation Treatment Influence on Post-operative Patients -Action SJM EPIC Trial

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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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Valve Disease
Device: Aortic valve replacement
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
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Inclusion Criteria:

  1. Patient requires, for the first time, isolated aortic valve replacement (pacemaker insertion is allowed)
  2. Patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements.
  3. Patient is of legal age in the host country
  4. The patient is in sinus rhythm before implantation

Exclusion Criteria:

  1. Patient already has a prosthetic valve, other than the valve being replaced at this time.
  2. Patient requires double valve implantation
  3. Patient requires concomitant CABG
  4. Patients requires intra aortic balloon pump at intervention
  5. 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)
  6. Patient requires ASA or AVK therapy, i.e. not suitable for randomization
  7. Patient is pregnant or nursing.
  8. Patient is affected by active endocarditis.
  9. Patient is affected by aortic dissection.
  10. Patient has history of cerebral ischemia
  11. Patient is affected by coagulopathy, history of GI bleeding or increased bleeding risk
  12. Patient is affected by peripheral vascular disease requiring treatment
  13. Patient has previous chronic anticoagulation therapy
  14. Patient is allergic to ASA and/or AVK
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00187304
CS04012TV
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St. Jude Medical
St. Jude Medical
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Principal Investigator: Jean-Phillippe Verhoye, MD CHU Pontchaillou Rennes France
St. Jude Medical
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP