Status:
RECRUITING
Colchicine in Belgium in Patients With Coronary Artery Disease After Percutaneous Coronary Intervention
Lead Sponsor:
AZ Sint-Jan AV
Collaborating Sponsors:
University Hospital, Ghent
Belgium Health Care Knowledge Centre
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
45+ years
Phase:
PHASE3
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 stan...
Detailed Description
This is a prospective, randomised, double-blind, multicenter, placebo-controlled phase III pragmatic superiority trial comparing colchicine 0.5 mg with placebo administered orally once-daily in up to ...
Eligibility Criteria
Inclusion
- Age ≥45 years.
- Coronary artery disease treated with PCI and optimal medical therapy, with at least one additional risk factor (based on SMART):
- Age ≥ year
- Diabetes mellitus, on treatment or new diagnosis with HbA1c ≥6.5%
- Current smoking
- Treated hypertension or lood pressure systolic ≥ 4 mmHg or diastolic ≥ mmHg
- Total cholesterol \>240 mg/dl untreated, or treated LDL \>70 mg/dl
- HDL \<40 mg/dl
- hsCRP \>2 mg/L AND chronic coronary syndrome (CCS)
- eGFR \<60 ml/min (MDRD)
- 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
- 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.
- 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 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.).
- 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.
- 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 cardiovascular intervention known on the day of screening.
- Currently enrolled in another investigational trial.
- Considered to be an unsuitable candidate by the investigator.
Key Trial Info
Start Date :
January 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
2770 Patients enrolled
Trial Details
Trial ID
NCT06095765
Start Date
January 29 2024
End Date
March 1 2028
Last Update
March 8 2024
Active Locations (19)
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1
Algemeen Stedelijk Ziekenhuis Campus Aalst
Aalst, Belgium, 9300
2
Het Ziekenhuisnetwerk Antwerpen
Antwerp, Belgium, 2020
3
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium, 2650
4
Imelda
Bonheiden, Belgium, 2820