Type 2 diabetic patients with no prior cardiovascular (CV) events
Conditions
Brief summary
The primary endpoint will be the time from randomization to the first event of the composite of cardiovascular death, resuscitated cardiac arrest, myocardial infarction (non-fatal), stroke (non-fatal), or urgent hospitalization for angina requiring coronary revascularization.
Detailed description
Times from randomization to each component of the primary endpoint; and to the first event of the composite of cardiovascular death, resuscitated cardiac arrest, myocardial infarction (non-fatal) or stroke (non-fatal), Total burden of first and subsequent primary endpoint events, Change from randomization in MoCA score at yearly follow-ups (excluding the first-year visit) until the end-of-study visit., Number and proportion of patients experiencing serious adverse events., For exploratory and safety end points please refer to the study protocol.
Interventions
DRUGMIGOUTINE 0
DRUG5 mg
DRUGcomprimé pelliculé
DRUGPlacebo tablet matching migoutine 0
DRUGACETYLSALICYLIC ACID
Sponsors
Montreal Heart Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the time from randomization to the first event of the composite of cardiovascular death, resuscitated cardiac arrest, myocardial infarction (non-fatal), stroke (non-fatal), or urgent hospitalization for angina requiring coronary revascularization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Times from randomization to each component of the primary endpoint; and to the first event of the composite of cardiovascular death, resuscitated cardiac arrest, myocardial infarction (non-fatal) or stroke (non-fatal), Total burden of first and subsequent primary endpoint events, Change from randomization in MoCA score at yearly follow-ups (excluding the first-year visit) until the end-of-study visit., Number and proportion of patients experiencing serious adverse events., For exploratory and safety end points please refer to the study protocol. | — |
Countries
Denmark, Finland, France, Greece, Italy, Portugal
Outcome results
None listed