cardiovascular disease MedDRA version: 20.0 Level: HLGT Classification code 10011082 Term: Coronary artery disorders System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Colchicine 0,5 mg Tiofarma, tabletten
Product Name: colchicine
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Werkgroep Cardiologische centra Nederland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >35 and 400). Individuals with a history of bypass surgery are only eligible if they have undergone coronary artery bypass surgery more than 10 years before, or have angiographic evidence of graft failure or have undergone percutaneous intervention since their bypass surgery 3. Clinically stable for at least six months 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 4023 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2030
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant, breast feeding or may be considering pregnancy during the study period 2. Renal impairment as evidenced by a serum creatinine >150 µmol/l or estimated glomerular filtration rate (eGFR) <50mL/min/1.73m2 3. Severe heart failure – systolic or diastolic New York Heart Association Functional classification 3 or 4 4. Moderate or severe valvular heart disease considered likely to require intervention 5. Dependency or frailty or an estimated life expectancy < 5 years 6. Peripheral neuritis, myositis or marked myo-sensitivity to statins 7. Requirement for long term colchicine therapy for any other reason 8. Current enrollment in another trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 75% and 100% of necessary endpoints;Main Objective: The primary objective of this study is to evaluate clinical efficacy of treatment with colchicine 0.5mg once daily as compared to placebo in patients with stable coronary artery disease on the incidence of first occurrence of the composite of cardiovascular death, myocardial infarction, ischemic stroke, or ischemia-driven revascularization. ;Secondary Objective: The secondary objectives of this study are to evaluate clinical efficacy of treatment with colchicine 0.5mg once daily as compared to placebo in patients with stable coronary artery disease on the incidence of first occurrence of 1. Myocardial infarction 2. Ischemia-driven revascularization 3. Cardiovascular death or myocardial infarction 4. Cardiovascular death 5. Death from any cause 6. the composite of sudden cardiac death, non-fatal out of hospital cardiac arrest, myocardial infarction or unstable angina irrespective of revascularization, or atherosclerotic ischemic stroke (the composite endpoint of the first LoDoCo trial), 7. the composite of cardiovascular death, non-fatal myocardial infarction or non-fatal ischemic stroke, 8. Acute coronary syndromes related to stent or graft disease, irrespective of revascularization ;Primary end point(s): The primary objective of this study is to evaluate clinical efficacy of treatment with colchicine 0.5mg once daily as compared to placebo in patients with stable coronary artery disease on the incidence of first occurrence of the composite of cardiovascular death, myocardial infarction, ischemic stroke, or ischemia-driven revascularization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objectives of this study are to evaluate clinical efficacy of treatment with colchicine 0.5mg once daily as compared to placebo in patients with stable coronary artery disease on the incidence of first occurrence of 1. Myocardial infarction 2. Ischemia-driven revascularization 3. Cardiovascular death or myocardial infarction 4. Cardiovascular death 5. Death from any cause 6. the composite of sudden cardiac death, non-fatal out of hospital cardiac arrest, myocardial infarction or unstable angina irrespective of revascularization, or atherosclerotic ischemic stroke (the composite endpoint of the first LoDoCo trial), 7. the composite of cardiovascular death, non-fatal myocardial infarction or non-fatal ischemic stroke, 8. Acute coronary syndromes related to stent or graft disease, irrespective of revascularization ;Timepoint(s) of evaluation of this end point: at 100% of the expected events | — |
Countries
Canada, Netherlands
Contacts
Public ContactChair WCN
Werkgroep Cardiologische centra Nederland
Outcome results
None listed