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ACTION - Anticoagulation Treatment Influence on Post-operative Patients

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00187304
Collaborator
(none)
0
Enrollment

Study Details

Study Description

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
  • Device: Aortic valve replacement
 Phase 4

Study Design

Study Type:
Interventional
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 :
Sep 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Abbott Medical Devices

    Investigators

    • Principal Investigator: Jean-Phillippe Verhoye, MD, CHU Pontchaillou Rennes France

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Devices
    ClinicalTrials.gov Identifier:
    NCT00187304
    Other Study ID Numbers:
    • CS04012TV
    First Posted:
    Sep 16, 2005
    Last Update Posted:
    Feb 4, 2019
    Last Verified:
    Feb 1, 2019
    Additional relevant MeSH terms:
    Heart Valve Diseases

    Study Results

    No Results Posted as of Feb 4, 2019