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ACTION - Anticoagulation Treatment Influence on Post-operative Patients

Primary Purpose

Heart Valve Disease

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Aortic valve replacement
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Valve Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 15, 2005
    Last Updated
    February 1, 2019
    Sponsor
    Abbott Medical Devices
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00187304
    Brief Title
    ACTION - Anticoagulation Treatment Influence on Post-operative Patients
    Official Title
    Anticoagulation Treatment Influence on Post-operative Patients -Action SJM EPIC Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study replaced by an observational study
    Study Start Date
    September 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Abbott Medical Devices

    4. Oversight

    5. 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Valve Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Aortic valve replacement

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jean-Phillippe Verhoye, MD
    Organizational Affiliation
    CHU Pontchaillou Rennes France
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    ACTION - Anticoagulation Treatment Influence on Post-operative Patients

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