MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study
NCT Number: NCT06543082
Acronym: MACT II
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Acute Coronary Syndrome
Interventions: DRUG: Colchicine 0.6 mg
Sponsor: CHA University
Collaborators: Biotronik SE & Co. KG
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 490
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-05
Completion Date: 2027-12-31
Locations: CHA Bundang Medical Center, Seongnam-si, Gyeonggi-do, 13496, Korea, Republic of

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.

Primary Outcome Measures: Efficacy 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, 12 months post-intervention|Safety Outcome: Stent thrombosis, Definite, probable, or possible stent thrombosis according to the Academic Research Consortium, 12 months post-intervention
Secondary Outcome Measures: 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., 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., 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., 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., 12 months post-intervention|Major bleeding, Bleeding Academic Research Consortium type 3 or 5, 12 months post-intervention|High residual inflammation, Participant with hs-CRP of ≥2 mg/L, 1 month, 6 months, and 12 months post-intervention|High residual platelet reactivity, Participant with P2Y12 reaction units of \>208, 1 month and 12 months post-intervention|Low residual platelet reactivity, Participant with P2Y12 reaction units of \<85, 1 month and 12 months post-intervention|Thrombogenicity, This will be measured using R, K, Angle, A10, MA, and Ly30 through thromboelastography., 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., 1 month, 3 months, 6 months, 9 months, and 12 months