- Low INR to Minimize Bleeding With Mechanical Valves Trial — Recruiting • Phase III • Cardiology / Cardiovascular • NCT03636295.
- What is being tested: The safety and efficacy of a lower INR target range (1.5-2.5) compared to standard anticoagulation in patients with mechanical bileaflet heart valves in the aortic position, specifically to determine if reduced anticoagulation intensity decreases bleeding complications.
- Patient eligibility overview: The trial includes patients who have undergone aortic valve replacement with a mechanical bileaflet prosthesis and require long-term anticoagulation; specific age, comorbidity, and risk stratification criteria will determine final inclusion.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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 valve who require lifelong warfarin (Coumadin) treatment.
- : * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.