ow-dose colchicine for prevention of cardiovascular disease after a cardiovascular event

Phase 1

• Conditions: cardiovascular disease; MedDRA version: 20.0Level: HLGTClassification code 10011082Term: Coronary artery disordersSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-005568-40-NL
• Lead Sponsor: Werkgroep Cardiologische centra Nederland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-25
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5447

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

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified