Clincosm LogoSign in Get a demo

Choice of Valve Substitute in the Era of Oral Anticoagulation Self-Management

Sponsor
Johann Wolfgang Goethe University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01269905
Collaborator
(none)

Study Details

Study Description

Brief Summary

The optimal valve substitute for patients between 60-70 years is controversial. We compared anticoagulation-related adverse events (ARAE) in patients receiving mechanical heart valve replacement (MHVR) on INR self-management vs. stentless bioprosthesis, to assess whether the risk of structural valve deterioration (SVD) is still out-weighted by the benefit of not requiring permanent anticoagulation.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective

    Arms and Interventions

    Arm Intervention/Treatment
    Group A

    Group A patients received mechanical heart valve replacement MHVR (and were educated in INR self-management using the Coagu-Check monitor.
    Group B

    Group B patients received MHVR and their anticoagulation was managed by their general practitioners.
    Group C

    Group C patients received stentless bioprosthesis, with initial 6 weeks on oral anticoagulation managed by their general practitioners.

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 90 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • heart valve replacement
      Exclusion Criteria:

      • CABG

      • Afib

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Johann Wolfgang Goethe University Hospital

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01269905
      Other Study ID Numbers:
      • COAG-001
      First Posted:
      Jan 4, 2011
      Last Update Posted:
      Jan 4, 2011
      Last Verified:
      Jan 1, 2005

      Study Results

      No Results Posted as of Jan 4, 2011