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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 4, 2011
Last Update Posted: January 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johann Wolfgang Goethe University Hospital
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.

Anticoagulation Mechanical Heart Valve Replacement

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

Further study details as provided by Johann Wolfgang Goethe University Hospital:

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.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients received heart valve replacement and were retrospectively allocated in three groups

Inclusion Criteria:

  • heart valve replacement

Exclusion Criteria:

  • CABG
  • Afib
  Contacts and Locations
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT01269905     History of Changes
Other Study ID Numbers: COAG-001
First Submitted: January 3, 2011
First Posted: January 4, 2011
Last Update Posted: January 4, 2011
Last Verified: January 2005