Recruiting
Phase 3

Mechanical Valves

Sponsor:

Population Health Research Institute

Code:

NCT03636295

Conditions

Bleeding Post-mechanical Valve Replacement

Thromboembolism Post-mechanical Valve Replacement

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Warfarin

Study Details

Brief summary:

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.

Conditions

Bleeding Post-mechanical Valve Replacement

Thromboembolism Post-mechanical Valve Replacement

Study ID

NCT03636295

Start date

Sep 5, 2019

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2625 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Reduced INR Target

Warfarin therapy will be titrated to a target INR in the range of 1.5 to 2.5.

active comparator: Standard INR Target

Warfarin therapy will be titrated to a "standard of care" target INR range.

Interventions

Warfarin

Participants in both arms will be on warfarin therapy post-mechanical valve replacement as is standard, but will have different INR target ranges.

Primary outcome measure

  • Thrombosis/thromboembolism [ Time Frame: Through study completion, an expected mean of 2-3 years ]
  • Major bleeding [ Time Frame: Through study completion, an expected mean of 2-3 years ]

Central Contacts and Locations

Central contacts

Emilie Belley-Côté, MD, MSc

905-527-4322emilie.belley-cote@phri.ca

Richard Whitlock, MD, PhD

905-527-4322richard.whitlock@phri.ca

Locations

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Emilie Belley-Cote, MD

905-527-4322emilie.belley-cote@phri.ca

London Health Sciences Centre Research Inc.

Recruiting

London, Ontario, Canada, N6C 2R5

Principal Investigator:

Linrui Guo, MD

The Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Principal Investigator:

Joseph Shaw, MD

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

More Information

Sponsor

Population Health Research Institute

Last update posted

Jan 6, 2026

Last verified

Dec, 2025

Keywords

  • Mechanical valve replacement
  • Vitamin K antagonist
  • INR targets
  • Bleeding
  • Thromboembolism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Population Health Research Institute on 2026-01-06.