Actively Recruiting
MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study
Led by CHA University · Updated on 2026-02-18
490
Participants Needed
9
Research Sites
225 weeks
Total Duration
On this page
Sponsors
C
CHA University
Lead Sponsor
B
Biotronik SE & Co. KG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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 or P-glycoprotein inhibitors.
- Presence of 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 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.
- Patients with active infectious diseases.
AI-Screening
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Trial Site Locations
Total: 9 locations
1
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea, 13496
Actively Recruiting
2
Keimyung University Dongsan Hospital
Daegu, South Korea
Actively Recruiting
3
Wonkwang University Hospital
Iksan, South Korea
Actively Recruiting
4
Myongji Hospital
Ilsan, South Korea
Actively Recruiting
5
National Health Insurance Service Ilsan Hospital
Ilsan, South Korea
Actively Recruiting
6
Seoul National University Bundang Hospital
Seongnam, South Korea
Actively Recruiting
7
Ewha Womans University Seoul Hospital
Seoul, South Korea
Actively Recruiting
8
Gangnam Severance Hospital
Seoul, South Korea
Actively Recruiting
9
Wonju Severance Christian Hospital
Wŏnju, South Korea
Actively Recruiting
Research Team
H
Hwa-In Kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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