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

Study Timeline

• Study Completion: 2020-02-17
• Last Update Posted: 23 April 2024

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

Name	Time	Method
<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>