ow INR to Minimize bleeding with mechanical valves Trial
Phase 1
- Conditions
- Treatment with a Vitamin K Antagonist due to having a mechanical heart valve.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2019-004975-37-ES
- Lead Sponsor
- Hamilton Health Sciences through the Population Health Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 2660
Inclusion Criteria
1) Have had a bileaflet mechanical heart valve implant in the aortic position =3 months ago,
2) Be =18 years of age at the time of enrolment,
3) Provide written informed consent (either from the patient or a substitute decision-maker).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1820
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 840
Exclusion Criteria
1) Have a second implanted mechanical valve (any position),
2) Lower boundary of planned INR range is less than 2.0,
3) 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