Evaluating colchicine therapy after heart procedures
Clinical Outcomes of Colchicine Therapy Following Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome: the MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study
This study is testing if adding a low dose of colchicine to a common heart medication can help people who have had heart procedures avoid serious heart problems in the year after their treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 490 (estimated) |
| Ages | 20 Years to 90 Years |
| Sex | All |
| Sponsor | CHA University Academic / other |
| Locations | 9 sites (Seongnam-si, Gyeonggi-do and 8 other locations) |
| Trial ID | NCT06543082 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of combining low-dose colchicine with ticagrelor P2Y12 inhibitor monotherapy in patients with acute coronary syndrome who have undergone percutaneous coronary intervention. The study aims to assess the frequency of serious cardiovascular events and stent thrombosis within 12 months post-intervention. Participants will be monitored for outcomes such as cardiovascular death, nonfatal myocardial infarction, and major bleeding. The trial builds on previous findings that suggested the feasibility of this treatment approach.
Who should consider this trial
Good fit: Ideal candidates include adults with acute coronary syndrome who have received ultrathin bioresorbable polymer sirolimus-eluting stents.
Not a fit: Patients with severe comorbid conditions or those taking contraindicated medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients with acute coronary syndrome.
How similar studies have performed: Previous pilot studies have shown feasibility, but this approach is still being evaluated for efficacy and safety.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants with positive troponin acute coronary syndrome who have undergone implantation of ultrathin bioresorbable polymer sirolimus-eluting stents (Orsiro; Biotronik AG). * Participants who have provided written informed consent. Exclusion Criteria: * Under 19 years of age. * Stent treatment failure lesions (stent restenosis or thrombosis). * Cardiac arrest or cardiogenic shock. * Currently taking or requiring strong CYP3A4 inhibitors (atazanavir, clarithromycin, darunavir/ritonavir, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, tipranavir/ritonavir) or P-glycoprotein inhibitors (cyclosporine, ranolazine). * Presence of any of the following concomitant conditions: myelosuppression, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, aplastic anemia, severe gastrointestinal diseases, or genetic disorders such as galactose intolerance. * Hypersensitivity to colchicine treatment. * Currently taking colchicine for another condition. * Requiring anticoagulant therapy. * Liver disease classified as Child-Pugh class B or C. * Renal disease with creatinine clearance \<30 mL/min. * Pregnant, breastfeeding, or women of childbearing age. * Currently has a malignancy or has a history of malignancy within the past 5 years. * Life expectancy of less than 5 years. * Contraindication for ticagrelor use (history of intracranial hemorrhage, active pathological bleeding, or liver disease classified as Child-Pugh class B or C). * Patients receiving regular administration of systemic steroids, immunosuppressants, or biological agents (e.g., TNF-alpha inhibitors) * Patients with active infectious diseases
Where this trial is running
Seongnam-si, Gyeonggi-do and 8 other locations
- CHA Bundang Medical Center — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
- Keimyung University Dongsan Hospital — Daegu, South Korea (Recruiting)
- Wonkwang University Hospital — Iksan, South Korea (Recruiting)
- Myongji Hospital — Ilsan, South Korea (Recruiting)
- National Health Insurance Service Ilsan Hospital — Ilsan, South Korea (Recruiting)
- Seoul National University Bundang Hospital — Seongnam, South Korea (Recruiting)
- Ewha Womans University Seoul Hospital — Seoul, South Korea (Recruiting)
- Gangnam Severance Hospital — Seoul, South Korea (Recruiting)
- Wonju Severance Christian Hospital — Wŏnju, South Korea (Recruiting)
Study contacts
- Principal investigator: Seung-Yul Lee, MD — CHA Bundang Medical Center
- Study coordinator: Hwa-In Kim
- Email: niawhz23@gmail.com
- Phone: 82-31-780-5858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.