AnticoagulationNCT01269905
Choice of Valve Substitute in the Era of Oral Anticoagulation Self-Management
An observational study of Anticoagulation and Mechanical Heart Valve Replacement, run by Johann Wolfgang Goethe University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anticoagulation, Mechanical Heart Valve Replacement
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients received heart valve replacement and were retrospectively allocated in three groups
Who may be able to join
- heart valve replacement
Who cannot join
- CABG
- Afib
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269905
- Sponsor's protocol ID
- COAG-001
- Status last verified
- Jan 2005
- First submitted
- 3 Jan 2011
- Last updated
- 4 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choice of Valve Substitute in the Era of Oral Anticoagulation Self-Management
- ClinicalTrials.gov ID
- NCT01269905
- Acronym / sponsor ID
- COAG-001
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- First posted
- 4 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients received heart valve replacement and were retrospectively allocated in three groups
Key inclusion criteria (1 listed)
- heart valve replacement
Key exclusion criteria (2 listed)
- CABG
- Afib
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulation and Mechanical Heart Valve Replacement, run by Johann Wolfgang Goethe University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2011.