NCT06095765 Colchicine in Belgium in Patients With Coronary Artery Disease After Percutaneous Coronary Intervention
| NCT ID | NCT06095765 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | AZ Sint-Jan AV |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,770 participants |
| Start Date | 2024-01-29 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 2,770 participants in total. It began in 2024-01-29 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Ian Buysschaert, MD, PhD
PRINCIPAL INVESTIGATOR
ian.buysschaert@azsintjan.be
Frequently Asked Questions
Who can join the NCT06095765 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06095765 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 2,770 participants.
Is NCT06095765 currently recruiting?
Yes, NCT06095765 is actively recruiting participants. Contact the research team at Lisette.VanHove@azsintjan.be for enrollment information.
Where is the NCT06095765 trial being conducted?
This trial is being conducted at Aalst, Belgium, Antwerp, Belgium, Antwerp, Belgium, Bonheiden, Belgium and 11 additional locations.
Who is sponsoring the NCT06095765 clinical trial?
NCT06095765 is sponsored by AZ Sint-Jan AV. The principal investigator is Ian Buysschaert, MD, PhD at ian.buysschaert@azsintjan.be. The trial plans to enroll 2,770 participants.