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Clinical Trials in Belgium / NCT06095765
Recruiting Phase 3

Colchicine in Belgium in Patients With Coronary Artery Disease After Percutaneous Coronary Intervention

NCT06095765 · tracked via the Priya Life Science Belgium tracker
Phase
Phase 3
Started
2024-01-29
Last updated
2024-03-08

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Colchicine 0.5 MG Oral Tablet →Placebo

Colchicine 0.5 MG Oral Tablet: Oral intake of 0.5 mg colchicine once daily

Placebo: Oral intake of matching placebo once daily

Study summary

The main aim of this trial is to determine whether there are fewer cardiovascular events when patients with coronary artery disease take a low dose of colchicine of 0.5 mg daily on top of optimal standard treatment after treatment with PCI, compared with placebo in combination with optimal standard treatment. More specifically, we aim to investigate the benefits of a daily low dose of colchicine in patients with coronary artery disease after treatment with PCI, to confirm that a daily low dose of colchicine helps prevent additional incidents in coronary artery disease, and to identify a subgroup of patients with CAD who are at increased risk for cardiovascular events and could benefit most from colchicine.

Eligibility

Sex
ALL
Min age
45 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥45 years. 2. Coronary artery disease treated with PCI and optimal medical therapy, with at least one additional risk factor (based on SMART): 1. Age ≥ year 2. Diabetes mellitus, on treatment or new diagnosis with HbA1c ≥6.5% 3. Current smoking 4. Treated hypertension or lood pressure systolic ≥ 4 mmHg or diastolic ≥ mmHg 5. Total cholesterol \>240 mg/dl untreated, or treated LDL \>70 mg/dl 6. HDL \<40 mg/dl 7. hsCRP \>2 mg/L AND chronic coronary syndrome (CCS) 8. eGFR \<60 ml/min (MDRD) 9. history of vascular disease: * CAD (PCI prior to index, CABG, MI) * stroke (ischemic or hemorrhagic) * carotid artery revascularisation * PAD (revascularisation, ABI \<0.85 at rest, amputation due to atherosclerotic disease) * AAA (repair, distal aortic anteroposterior diameter \>3.0cm) 3. Able to be enrolled/randomized between 2 hour and 5 days post PCI. 4. Written informed consent. Exclusion Criteria: 1. Women who are pregnant, breastfeeding, or of childbearing potential who are not using an effective method of contraception. Or women who intend to donate oocytes. 2. Men who plan to father children during the study period or who are unwilling to use effective forms of contraception. Or men who intend to donate sperm. 3. Any contraindication or known intolerance to colchicine. 4. Chronic use of -or need for- colchicine. 5. Auto-immune disease or other condition requiring current or planned chronic systemic steroids, immunosuppressant or biologic drug targeting the immune system (for example, TNF blockers, anakinra, rituximab, abatacept, tocilizumab etc.). 6. Creatinine clearance \<30 mL/min/1.73 m2. 7. Cirrhosis Child-Pugh stadium B and C, or acute severe liver disease 8. Neuromuscular disease or non-transient CK levels \> 5 x ULN (unless due to MI). 9. History of cancer or lymphoproliferative disease within the last 3 years, other than successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, or localized cervix carcinoma in situ. 10. Current or planned use of any strong inhibitor of CYP3A4 or p-glycoprotein: macrolide antibiotics (clarithromycin, telithromycin), azole antifungal agents (ketoconazole, voriconazole, fluconazole, itraconazole), cyclosporine, HIV medication (ritonavir, lopinavir, tipranavir, atazanavir, darunavir, indinavir, saquinavir). 11. Chronic diarrhea, or inflammatory owel disease (Crohn's disease or ulcerative colitis). 12. Drug or alcohol abuse. 13. Planned cardiovascular intervention known on the day of screening. 14. Currently enrolled in another investigational trial. 15. Considered to be an unsuitable candidate by the investigator.

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
Algemeen Stedelijk Ziekenhuis Campus Aalst Aalst Belgium Recruiting
Het Ziekenhuisnetwerk Antwerpen Antwerp Belgium Recruiting
Universitair Ziekenhuis Antwerpen Antwerp Belgium Recruiting
Imelda Bonheiden Belgium Recruiting
AZ Sint-Jan Brugge-Oostende AV Bruges Belgium Recruiting
Humani Charleroi Charleroi Belgium Recruiting
Grand Hôpital de Charleroi Charleroi Belgium Not Yet Recruiting
Ziekenhuis Oost Limburg Genk Belgium Recruiting
AZ Sint-Lucas & Volkskliniek Ghent Belgium Recruiting
Universitair Ziekenhuis Gent Ghent Belgium Recruiting
Jessa Ziekenhuis Hasselt Belgium Recruiting
Algemeen Ziekenhuis Groeninge Kortrijk Belgium Recruiting
UZ Leuven Leuven Belgium Recruiting
Centre Hospitalier Regional De La Citadelle Liège Belgium Recruiting
Clinique Saint-Luc Bouge Namur Belgium Recruiting
AZ Delta Roeselare Belgium Recruiting
AZ Turnhout Turnhout Belgium Recruiting
Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium Recruiting
UCL Mont-Godinne Yvoir Belgium Recruiting

More AZ Sint-Jan AV trials in Belgium

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06095765 on ClinicalTrials.gov ↗ ← All trials in Belgium