NCT06543082RecruitingPhase 4
MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study
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
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 490 (estimated)
- First submitted
- 3 Aug 2024
- Start date
- 5 Aug 2024
- Primary completion date
- Dec 2028
- Lead sponsor
- CHA University
- Diseases
- Coronary artery disease
- NCT number
- NCT06543082
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 490
- From 5 Aug 2024 to the primary completion date, Dec 2028
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Currently taking colchicine for another condition.
- Requiring anticoagulant therapy.
- Patients receiving regular administration of systemic steroids, immunosuppressants, or biological agents (e.g., TNF-alpha inhibitors)
Other illness
- Stent treatment failure lesions (stent restenosis or thrombosis).
- Cardiac arrest or cardiogenic shock.
- Hypersensitivity to colchicine treatment.
- Liver disease classified as Child-Pugh class B or C.
- Currently has a malignancy or has a history of malignancy within the past 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 with active infectious diseases
Lab values
- Renal disease with creatinine clearance \<30 mL/min.
Age
- Under 19 years of age.
- Pregnant, breastfeeding, or women of childbearing age.
Other
- Life expectancy of less than 5 years.
Who the study is looking for
- 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.
Age in the registry: 20 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Keimyung University Dongsan Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Wonkwang University Hospital Coordinator of this site? Confirm its status | Iksan | South Korea | Recruiting |
| National Health Insurance Service Ilsan Hospital Coordinator of this site? Confirm its status | Ilsan | South Korea | Recruiting |
| Myongji Hospital Coordinator of this site? Confirm its status | Ilsan | South Korea | Recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Recruiting |
| CHA Bundang Medical Center Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
| Gangnam Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Ewha Womans University Seoul Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Wonju Severance Christian Hospital Coordinator of this site? Confirm its status | Wŏnju | South Korea | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.