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ACTION - Anticoagulation Treatment Influence on Post-operative Patients

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ClinicalTrials.gov Identifier: NCT00187304
Recruitment Status : Withdrawn (Study replaced by an observational study)
First Posted : September 16, 2005
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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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™ 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 or disease Intervention/treatment Phase
Heart Valve Disease Device: Aortic valve replacement Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anticoagulation Treatment Influence on Post-operative Patients -Action SJM EPIC Trial
Study Start Date : September 2005

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187304


Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Jean-Phillippe Verhoye, MD CHU Pontchaillou Rennes France
More Information
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00187304    
Other Study ID Numbers: CS04012TV
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases