Choice of Valve Substitute in the Era of Oral Anticoagulation Self-Management
This study has been completed.
Sponsor:
Johann Wolfgang Goethe University Hospitals
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01269905
First received: January 3, 2011
Last updated: NA
Last verified: January 2005
History: No changes posted
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Purpose
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 |
|---|
|
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 Hospitals:
| Groups/Cohorts |
|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients received heart valve replacement and were retrospectively allocated in three groups
Criteria
Inclusion Criteria:
- heart valve replacement
Exclusion Criteria:
- CABG
- Afib
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01269905 History of Changes |
| Other Study ID Numbers: | COAG-001 |
| Study First Received: | January 3, 2011 |
| Last Updated: | January 3, 2011 |
| Health Authority: | Germany: Ethics Commission |
ClinicalTrials.gov processed this record on May 23, 2013