Major cardiovascular events (MACE), spontaneous intracerebral hemorrhage
Conditions
Brief summary
Hierarchical composite endpoint (HCE) that combines MACE and dependency, which includes the following components:, a. time-to first stroke (ischemic, hemorrhagic or undefined), b. time-to cardiovascular death, c. dependency, defined as modified Rankin Scale scores (mRS) between 3 and 5, at 6 months from randomization, d. time-to first myocardial infarction, e. time-to first revascularization procedure for coronary, carotid, or peripheral arterial disease
Detailed description
Functional outcome at 6-months, assessed with the modified Rankin Score (mRS) scale, Cognitive outcome at the end of study, assessed by the telephone Montreal Cognitive Assessment (T-MoCA) and the telephone Mental Alternation Test (t-MAT), Quality of life at the end of study, assessed with the EQ-5D-5L [global questionnaire], Disabling or fatal stroke during follow-ups, assessed with the Modified Rankin Scale (mRS) scale
Interventions
DRUGColchicine Aspire 0.5 mg Tablets
DRUGPlacebo 0.5mg tablet
Sponsors
Hamilton Health Sciences Corporation, PHRI Population Health Research Institute International
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hierarchical composite endpoint (HCE) that combines MACE and dependency, which includes the following components:, a. time-to first stroke (ischemic, hemorrhagic or undefined), b. time-to cardiovascular death, c. dependency, defined as modified Rankin Scale scores (mRS) between 3 and 5, at 6 months from randomization, d. time-to first myocardial infarction, e. time-to first revascularization procedure for coronary, carotid, or peripheral arterial disease | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional outcome at 6-months, assessed with the modified Rankin Score (mRS) scale, Cognitive outcome at the end of study, assessed by the telephone Montreal Cognitive Assessment (T-MoCA) and the telephone Mental Alternation Test (t-MAT), Quality of life at the end of study, assessed with the EQ-5D-5L [global questionnaire], Disabling or fatal stroke during follow-ups, assessed with the Modified Rankin Scale (mRS) scale | — |
Outcome results
None listed