Low INR to Minimize Bleeding With Mechanical Valves Trial
Recruiting
Phase 3
Interventional Study
Bleeding Post-mechanical Valve Replacement
Thromboembolism Post-mechanical Valve Replacement
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 2,625 (estimated)
- Sponsor
- Population Health Research Institute · Other
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About This Trial
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. These results have the potential to reduce the burden of bleeding in patients with a mechanical heart…
Trial Locations
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Eligibility Criteria
Inclusion criteria:
* 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
Exclusion criteria:
* Has a second implanted mechanic…
Contacts