ow INR to Minimize bleeding with mechanical valves Trial (LIMIT)
Phase 1
- Conditions
- Treatment with a Vitamin K Antagonist due to having a mechanical bileaflet aortic valve replacement.MedDRA version: 20.0Level: PTClassification code: 10002916Term: Aortic valve replacement Class: 100000004865Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-508532-56-00
- Lead Sponsor
- Hamilton Health Sciences Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1880
Inclusion Criteria
Have had a bileaflet mechanical heart valve implant in the aortic position at least 3 months ago (greater than or equal to 3 months), Be at least 18 years of age at the time of enrollment (greater than or equal to 18 years of age), Provide written informed consent (either from the patient or substitute decision-maker)
Exclusion Criteria
Have 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
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method