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COLchicine in BElgium in patients with coronary artery disease after Percutaneous Coronary Intervention
EU CTIS ID: 2023-505028-74-00
What this study is testing
To demonstrate that colchicine 0.5 mg daily reduces first occurrence of a composite endpoint consisting of: all-cause death, spontaneous (non-procedural) non-fatal myocardial infarction, non-fatal stroke, or coronary revascularisation, whichever occurs first, in patients with CAD treated with PCI.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.