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New treatment option for Bleeding Post-mechanical Valve Replacement
Official title Low INR to Minimize Bleeding With Mechanical Valves Trial
ClinicalTrials.gov ID: NCT03636295
What this study is testing
What is Warfarin?
Warfarin is an investigational medicine, being studied as a potential treatment for bleeding post-mechanical valve replacement.
Also referred to as Coumadin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study evaluates the use of a lower INR target (1.5 to 2.5) in patients with a mechanical bileaflet heart valve in the aortic position. This study will inform physicians about whether a lower INR target will decrease the risk of bleeding or increase the risk of blood clot formation and stroke.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age is 18 or older at the time of enrolment
- Have had a bileaflet mechanical heart valve implant in the aortic position 3 or more months ago
- Written informed consent from either the patient or substitute decision maker
You likely can't join if
- Has a second implanted mechanical valve (any position)
- Lower boundary of planned INR range is less than 2.0
- Pregnant or expecting to become pregnant during the study follow-up
The study team makes the final eligibility decision.
Where it's taking place
- Genk, Limburg, Belgium
- Ostend, West-Vlaanderen, Belgium
- Keerbergen, Belgium
- Leuven, Belgium
- Gaborone, Botswana
- Campina Grande do Sul, Paraná, Brazil
- Joinville, Santa Catarina, Brazil
- Cerqueira César, São Paulo, Brazil
- Brasília, Brazil
- São Paulo, Brazil
- Kumbo, Cameroon
- Halifax, Nova Scotia, Canada
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Ottawa, Ontario, Canada
- Montreal, Quebec, Canada
- Beijing, China
- Esbjerg, Region Syddanmark, Denmark
- Aabenraa, Denmark
- Aarhus, Denmark
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Genk, Limburg, Belgium; Ostend, West-Vlaanderen, Belgium; Keerbergen, Belgium; Leuven, Belgium; Gaborone, Botswana; Campina Grande do Sul, Paraná, Brazil and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.