Treatment with a Vitamin K Antagonist due to having a mechanical heart valve.
Conditions
Interventions
Trade Name: Marcoumar
Pharmaceutical Form: Tablet
INN or Proposed INN: PHENPROCOUMON
CAS Number: 435-97-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Trade
Sponsors
Hamilton Health Sciences through the Population Health Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective in the vanguard phase of the LIMIT trial is to assess the feasibility of recruiting 400 subjects over approximately 3 years at 5 centres. The objectives in the full trial are to evaluate the safety and effectiveness of a common, lower INR target range in patients with bileaflet aortic mechanical valves.;Secondary Objective: NA;Primary end point(s): The primary outcome for the vanguard phase of the trial will be the ability to recruit 400 subjects over 3 years. The primary outcome for the full trial will be the incidence of major bleeding over follow up.;Timepoint(s) of evaluation of this end point: For the vanguard phase, feasibility measures will be analyzed upon reaching 400 patients. The DSMB will review safety data in the vanguard phase after 150 patients have been recruited and have completed 6 months of follow-up. Follow up for the full trial will occur every 6 months until 120 primary outcome events have occurred. We expect this to occur after a mean of 2 to 3 years of follow-up. After reaching 120 events, a final phone follow-up will occur with all randomized patients to allow a more thorough assessment of outcomes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary outcomes of the vanguard phase are: 1) Proportion of established prevalent (>1 year) valve patients consented/approached, 2) Proportion of new valve (50 mm, spontaneous echocardiographic contrast in the left atrium, significant vascular disease, history of neurological events within 1 year, hypercoagulability, left or right ventricular aneurysm, and women receiving estrogen replacement therapy), 6) The estimated time in the therapeutic range in each group The secondary outcomes of the full trial are: 1) All-cause mortality (selected rather than cardiovascular mortality, as cause-specific mortality is often difficult to ascertain or define in complex cardiovascular patients in whom multi-end-organ dysfunction may accompany cardiovascular decline), 2) All bleeding, 3) All stroke, 4) Ischemic stroke, 5) Hemorrhagic stroke, 6) Type 1, 2 or 3 myocardial infarction, 7) Systemic thromboembolism, 8) Valve thrombosis, 9) Pulmonary embolism, 10) Deep vein thrombosis, 11) New renal replacement therapy, 12) Time in therapeutic range, 13) Proportion of patients with extreme INR values (>4);Timepoint(s) of evaluation of this end point: Follow up for the full trial will occur every 6 months until 120 primary outcome events have occurred. We expect this to occur after a mean of 2 to 3 years of follow-up. After reaching 120 events, a final phone follow-up will occur with all randomized patients to allow a more thorough assessment of outcomes. | — |
Countries
Belgium, Canada, Germany, Italy, Netherlands, Russian Federation, Spain
Contacts
Public ContactLIMIT Project Office
PHRI
Outcome results
None listed