COLchicine in BElgium in patients with coronary artery disease after Percutaneous Coronary Interventio

Phase 1

Recruiting

• Conditions: Coronary artery disease; MedDRA version: 20.0Level: PTClassification code: 10011078Term: Coronary artery disease Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-505028-74-00
• Lead Sponsor: niversitair Ziekenhuis Gent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-29
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 2770

Inclusion Criteria

Age =45 years., Coronary artery disease treated with PCI and optimal medical therapy, with at least one additional risk factor (based on SMART): a. Age = year b. Diabetes mellitus, on treatment or new diagnosis with HbA1c =6.5% c. Current smoking d. Treated hypertension or lood pressure systolic = 4 mmHg or diastolic = mmHg e. Total cholesterol >240 mg/dl untreated, or treated LDL >70 mg/dl f. HDL <40 mg/dl g. hsCRP >2 mg/dl AND chronic coronary syndrome (CCS) h. eGFR <60 ml/min (MDRD) i. 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), Able to be enrolled/randomized between 2 hour and 5 days post PCI., Written informed consent.

Exclusion Criteria

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., 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)., Chronic diarrhea, or inflammatory owel disease (Crohn’s disease or ulcerative colitis)., Drug or alcohol abuse., Planned coronary, carotid or peripheral revascularisation known on the day of screening., Currently enrolled in another investigational trial., Considered to be an unsuitable candidate by the investigator., 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., Any contraindication or known intolerance to colchicine., Chronic use of -or need for- colchicine., Auto-immune disease requiring current or planned chronic systemic steroids, immunosuppressant or biologic drug targeting the immune system (for example, TNF blockers, anakinra, rituximab, abatacept, tocilizumab etc.)., Creatinine clearance <30 mL/min/1.73 m2., Cirrhosis Child-Pugh stadium B and C, or acute severe liver disease, Neuromuscular disease or non-transient CK levels > 5 x ULN (unless due to MI)., 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.

Study & Design

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