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

January 3, 2011 updated 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients received heart valve replacement and were retrospectively allocated in three groups

Description

Inclusion Criteria:

  • heart valve replacement

Exclusion Criteria:

  • CABG
  • Afib

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 3, 2011

First Submitted That Met QC Criteria

January 3, 2011

First Posted (Estimate)

January 4, 2011

Study Record Updates

Last Update Posted (Estimate)

January 4, 2011

Last Update Submitted That Met QC Criteria

January 3, 2011

Last Verified

January 1, 2005

More Information

Terms related to this study

Other Study ID Numbers

  • COAG-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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