Colchicine for the Reduction of Dependency and Vascular Events after an Acute Intracerebral Hemorrhage (CoVasc-ICH2)

Condition studied

Major cardiovascular events (MACE), spontaneous intracerebral hemorrhage

Investigational medicinal product(s)

Eligibility

Primary endpoint

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

Endpoint detail

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