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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
490
Participants will take low-dose colchicine (0.6 mg once daily) in addition to ticagrelor maintenance therapy (90 mg twice daily), and discontinue aspirin the day after PCI. They will have an hs-CRP test 1 month after PCI. If the hs-CRP level is below 2 mg/L, colchicine will be discontinued 1 month after PCI. If it is 2 mg/L or higher, colchicine will be continued for 12 months after PCI.
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGKeimyung University Dongsan Hospital
Daegu, South Korea
RECRUITINGWonkwang University Hospital
Iksan, South Korea
RECRUITINGMyongji Hospital
Ilsan, South Korea
RECRUITINGNational Health Insurance Service Ilsan Hospital
Ilsan, South Korea
RECRUITINGSeoul National University Bundang Hospital
Seongnam, South Korea
RECRUITINGEwha Womans University Seoul Hospital
Seoul, South Korea
RECRUITINGGangnam Severance Hospital
Seoul, South Korea
RECRUITINGWonju Severance Christian Hospital
Wŏnju, South Korea
RECRUITINGEfficacy Outcome: Net adverse clinical event
The composite of cardiovascular death, nonfatal spontaneous (nonprocedural) myocardial infarction, nonfatal ischemic stroke, unplanned hospitalization leading to urgent revascularization, and major bleeding
Time frame: 12 months post-intervention
Safety Outcome: Stent thrombosis
Definite, probable, or possible stent thrombosis according to the Academic Research Consortium
Time frame: 12 months post-intervention
Cardiovascular death
The composite of cardiac and vascular death. Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death. Death caused by noncoronary vascular causes, such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular diseases will be classified as vascular death.
Time frame: 12 months post-intervention
Nonfatal spontaneous (nonprocedural) myocardial infarction
Myocardial infarction is defined as symptoms, electrocardiographic changes, or abnormal imaging findings, combined with a creatine kinase MB fraction above the upper normal limits or a troponin T or troponin I level greater than the 99th percentile of the upper normal limit. Myocardial infarction that are not associated with a revascularization procedure will be classified as nonfatal spontaneous myocardial infarction.
Time frame: 12 months post-intervention
Nonfatal ischemic stroke
Cerebrovascular event resulting in a neurologic deficit within 24 hours or the presence of acute infarction as demonstrated by imaging studies will be classified as nonfatal ischemic stroke.
Time frame: 12 months post-intervention
Unplanned hospitalization leading to urgent revascularization
This event will be present only if the participant is hospitalized unexpectedly because of persisting or increasing complaints of chest pain (with or without ST-T changes, with or without elevated biomarkers) and a revascularization is performed within the same hospitalization. It should be clearly distinguished from the revascularization procedure which is performed on non-urgent basis.
Time frame: 12 months post-intervention
Major bleeding
Bleeding Academic Research Consortium type 3 or 5
Time frame: 12 months post-intervention
High residual inflammation
Participant with hs-CRP of ≥2 mg/L
Time frame: 1 month, 6 months, and 12 months post-intervention
High residual platelet reactivity
Participant with P2Y12 reaction units of \>208
Time frame: 1 month and 12 months post-intervention
Low residual platelet reactivity
Participant with P2Y12 reaction units of \<85
Time frame: 1 month and 12 months post-intervention
Thrombogenicity
This will be measured using R, K, Angle, A10, MA, and Ly30 through thromboelastography.
Time frame: 1 month and 12 months post-intervention
Adverse drug reaction to colchicine
Response to a colchicine which is noxious and unintended and which occurs during the administration period.
Time frame: 1 month, 3 months, 6 months, 9 months, and 12 months
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