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Lowering INR targets to reduce bleeding in patients with mechanical heart valves

Low INR to Minimize Bleeding With Mechanical Valves Trial

Phase 3 Interventional Population Health Research Institute · NCT03636295

This study is testing if setting a lower blood clotting target for patients with mechanical heart valves can help reduce bleeding risks without causing more blood clots or strokes.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment2625 (estimated)
Ages18 Years and up
SexAll
SponsorPopulation Health Research Institute Academic / other
Locations35 sites (Genk, Limburg and 34 other locations)
Trial IDNCT03636295 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a lower INR target range (1.5 to 2.5) in patients who have undergone mechanical bileaflet heart valve replacement in the aortic position. It aims to determine whether this lower target can reduce the risk of bleeding without increasing the risk of thromboembolism or stroke. Participants will be monitored while receiving warfarin (Coumadin) treatment, and the outcomes will help inform clinical guidelines regarding INR management in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older who have had a bileaflet mechanical heart valve implanted in the aortic position for at least three months.

Not a fit: Patients with multiple mechanical valves or those who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of bleeding complications in patients with mechanical heart valves.

How similar studies have performed: Previous studies have shown promising results with similar lower INR target approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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 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

Where this trial is running

Genk, Limburg and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Bleeding Post-mechanical Valve ReplacementThromboembolism Post-mechanical Valve ReplacementMechanical valve replacementVitamin K antagonistINR targetsBleedingThromboembolism
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.