Logo 1 Logo 2

Clinical Trial Details

Trial ID: L2565
Source ID: NCT05633810
Associated Drug: Aspirin
Title: COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes
Acronym: COLCOT-T2D
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabete Type 2|Cardiovascular Diseases
Interventions: DRUG: Aspirin|DRUG: Aspirin Placebo|DRUG: Colchicine|DRUG: Colchicine Placebo
Outcome Measures: Primary: First event of the composite of cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, non-fatal stroke, or urgent hospitalization for angina requiring coronary revascularization., The number of participants having at least one of the composite of the primary endpoint., From randomization to occurrence of first event, assessed up to 60 months. | Secondary: Cardiovascular Death, The number of participants having a cardiovascular death., From randomization to cardiovascular death, assessed up to 60 months.|First Event of Resuscitated Cardiac Arrest, The number of participants having at least 1 resuscitated cardiac arrest., From randomization to event, assessed up to 60 months.|First Event of Non-fatal Myocardial Infarction, The number of participants having at least 1 myocardial infarction., From randomization to event, assessed up to 60 months.|First Event of Non-fatal Stroke, The number of participants having at least 1 stroke., From randomization to event, assessed up to 60 months|First Occurrence of Urgent Hospitalization for Angina Requiring Coronary Revascularization, The number of participants having at least 1 urgent hospitalization for angina requiring coronary revascularization., From randomization to occurrence, assessed up to 60 months.|First Event of Atrial Fibrillation, The number of participants having at least 1 atrial fibrillation., From randomization to event, assessed up to 60 months.|First Occurrence of Heart Failure Hospitalization, The number of participants having at least 1 heart failure hospitalization., From randomization to occurrence, assessed up to 60 months.|First Occurrence of Coronary Revascularization, The number of participants having at least 1 coronary revascularization., From randomization to occurrence, assessed up to 60 months.|MoCA Scores Assessed Over Time, Change from randomization in MoCA score at yearly follow-ups (excluding the first-year visit) until the end-of-study visit., From randomization to yearly follow-ups until the end-of-study visit, assessed up to 60 months.
Sponsor/Collaborators: Sponsor: Montreal Heart Institute
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 10000
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2022-12-21
Completion Date: 2027-12
Results First Posted:
Last Update Posted: 2024-06-06
Locations: Montreal Heart Institute, Montréal, Quebec, Canada
URL: https://clinicaltrials.gov/show/NCT05633810