Using colchicine to reduce heart events in patients after heart artery procedures

Colchicine in Belgium in Patients With Coronary Artery Disease

This study is testing if a low dose of colchicine can help prevent heart problems in patients with coronary artery disease who have just had heart artery procedures.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 2770 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: AZ Sint-Jan AV (other)
• Drugs / interventions: rituximab, tocilizumab
• Locations: 19 sites (Aalst and 18 other locations)
• Trial ID: NCT06095765 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate the effectiveness of a low dose of colchicine (0.5 mg daily) in reducing cardiovascular events in patients with coronary artery disease (CAD) who have undergone percutaneous coronary intervention (PCI). It is a phase III, randomized, double-blind, multicenter, placebo-controlled trial involving up to 2770 participants. Patients will be randomly assigned to receive either colchicine or a placebo alongside standard medical treatment, with follow-up assessments conducted at regular intervals to monitor outcomes. The study seeks to identify specific patient subgroups that may benefit most from colchicine therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 45 and older with coronary artery disease treated with PCI and at least one additional cardiovascular risk factor.

Not a fit: Patients who do not have coronary artery disease or those who are not eligible due to exclusion criteria, such as women, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of further cardiovascular events in patients with coronary artery disease.

How similar studies have performed: Previous studies have shown promising results with colchicine in cardiovascular settings, suggesting potential for success in this approach.

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.

Where this trial is running

Aalst and 18 other locations

• Algemeen Stedelijk Ziekenhuis Campus Aalst — Aalst, Belgium (RECRUITING)
• Het Ziekenhuisnetwerk Antwerpen — Antwerp, Belgium (RECRUITING)
• Universitair Ziekenhuis Antwerpen — Antwerp, Belgium (RECRUITING)
• Imelda — Bonheiden, Belgium (RECRUITING)
• AZ Sint-Jan Brugge-Oostende AV — Bruges, Belgium (RECRUITING)
• Humani Charleroi — Charleroi, Belgium (RECRUITING)
• Grand Hôpital de Charleroi — Charleroi, Belgium (NOT_YET_RECRUITING)
• Ziekenhuis Oost Limburg — Genk, Belgium (RECRUITING)
• AZ Sint-Lucas & Volkskliniek — Ghent, Belgium (RECRUITING)
• Universitair Ziekenhuis Gent — Ghent, Belgium (RECRUITING)
• Jessa Ziekenhuis — Hasselt, Belgium (RECRUITING)
• Algemeen Ziekenhuis Groeninge — Kortrijk, Belgium (RECRUITING)
• UZ Leuven — Leuven, Belgium (RECRUITING)
• Centre Hospitalier Regional De La Citadelle — Liège, Belgium (RECRUITING)
• Clinique Saint-Luc Bouge — Namur, Belgium (RECRUITING)
• AZ Delta — Roeselare, Belgium (RECRUITING)
• AZ Turnhout — Turnhout, Belgium (RECRUITING)
• Cliniques Universitaires Saint-Luc — Woluwe-Saint-Lambert, Belgium (RECRUITING)
• UCL Mont-Godinne — Yvoir, Belgium (RECRUITING)

Study contacts

• Principal investigator: Ian Buysschaert, MD, PhD — [e-mail]
• Study coordinator: Lisette Van Hove

Conditions: Coronary Artery Disease, percutaneous coronary intervention, colchicine