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

Prior treatment

• Drug or alcohol abuse.

Other illness

• 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.).
• Cirrhosis Child-Pugh stadium B and C, or acute severe liver disease
• 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).

Lab values

• Creatinine clearance \<30 mL/min/1.73 m2.
• Neuromuscular disease or non-transient CK levels \> 5 x ULN (unless due to MI).

Other

• 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.
• Planned cardiovascular intervention known on the day of screening.
• Currently enrolled in another investigational trial.
• Considered to be an unsuitable candidate by the investigator.

• 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.