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ow-dose colchicine for secondary prevention of cardiovascular disease - LoDoCo2 trial

Phase 3
Completed
Conditions
stable coronary artery disease
atherosclerosis
10011082
Registration Number
NL-OMON50634
Lead Sponsor
WCN (Werkgroep Cardiologische centra Nederland)
Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
5522
Inclusion Criteria

1. Age >35 and <82 years
2. Proven coronary artery disease; as evidenced by coronary angiography, CT
coronary angiography or a Coronary Artery Calcium Score (Agatston score >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

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, frailty or a predicted 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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>the composite outcome of sudden cardiac death, non-fatal out of hospital<br /><br>cardiac arrest, acute coronary syndromes or atherosclerotic ischemic stroke.<br /><br><br /><br>per protocol v2.6 20 August 2019 changed into<br /><br>the composite outcome of cardiovascular death, myocardial infarction, ischemic<br /><br>stroke, or ischemia-driven revascularization.<br /><br><br /><br>per protocol v2.7 22 January 2020 changed into<br /><br>the composite of cardiovascular death, myocardial infarction, ischemic stroke,<br /><br>or ischemia-driven coronary revascularization. </p><br>
Secondary Outcome Measures
NameTimeMethod
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