NCT06543082 MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study
| NCT ID | NCT06543082 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | CHA University |
| Condition | Acute Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 490 participants |
| Start Date | 2024-08-05 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 490 participants in total. It began in 2024-08-05 with a primary completion date of 2028-12.
⚠ 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 previous Mono Antiplatelet and Colchicine Therapy (MACT) pilot study (NCT04949516) demonstrated that it was feasible to discontinue aspirin therapy and administer low-dose colchicine on the day after percutaneous coronary intervention (PCI) in addition to potent P2Y12 inhibitors in patients with acute coronary syndrome (ACS). However, the efficacy and safety of MACT have not yet been investigated. The goal of this clinical trial is to evaluate the clinical outcomes of ticagrelor P2Y12 inhibitor monotherapy combined with colchicine immediately after PCI in patients with ACS. The main questions it aims to answer are: * What is the frequency of the composite endpoint of cardiovascular death, nonfatal spontaneous myocardial infarction, nonfatal ischemic stroke, unplanned hospitalization leading to urgent revascularization, and major bleeding at 12 months post-intervention? * What is the frequency of stent thrombosis at 12 months post-intervention? For pre-specified analyses, researchers will compare MACT to less than 1 month, 3-month, and 12-month dual antiplatelet therapy (individual patient data from the T-PASS \[NCT03797651\] and TICO \[NCT02494895\] trials) to determine if MACT is effective in treating ACS. Participants will: * Take low-dose colchicine in addition to ticagrelor maintenance therapy, discontinuing aspirin the day after PCI. * Take a high-sensitivity C-reactive protein (hs-CRP) test 1 month after PCI. * Discontinue colchicine if the hs-CRP level is less than 2 mg/L, or continue colchicine if it is not. * Visit the clinic for check-ups at 1, 3, 6, 9, and 12 months after PCI.
Eligibility 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
Contact & Investigator
Seung-Yul Lee, MD
PRINCIPAL INVESTIGATOR
CHA Bundang Medical Center
Frequently Asked Questions
Who can join the NCT06543082 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 90 Years, studying Acute Coronary Syndrome. 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 NCT06543082 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06543082 currently recruiting?
Yes, NCT06543082 is actively recruiting participants. Contact the research team at niawhz23@gmail.com for enrollment information.
Where is the NCT06543082 trial being conducted?
This trial is being conducted at Seongnam-si, South Korea, Daegu, South Korea, Iksan, South Korea, Ilsan, South Korea and 5 additional locations.
Who is sponsoring the NCT06543082 clinical trial?
NCT06543082 is sponsored by CHA University. The principal investigator is Seung-Yul Lee, MD at CHA Bundang Medical Center. The trial plans to enroll 490 participants.