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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
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.
Age
20 - 90 years
Sex
ALL
Healthy Volunteers
No
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Wonkwang University Hospital
Iksan, South Korea
Myongji Hospital
Ilsan, South Korea
National Health Insurance Service Ilsan Hospital
Ilsan, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Ewha Womans University Seoul Hospital
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea
Start Date
August 5, 2024
Primary Completion Date
December 1, 2028
Completion Date
December 1, 2028
Last Updated
February 18, 2026
490
ESTIMATED participants
Colchicine 0.6 mg
DRUG
Lead Sponsor
CHA University
Collaborators
NCT07436429
NCT07429227
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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