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MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study

Study acronym: MACT II
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Study sites: 1 to 9
    • Primary and study completion dates: Dec 31, 2028 to Dec 2028
    • Eligibility criteria expanded, about 19 words
    v4
  2. Primary completion date: Aug 5, 2027 to Dec 31, 2028
    • Study completion date: Dec 31, 2027 to Dec 31, 2028
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06543082
Lead Sponsor CHA University
Collaborators: Biotronik SE & Co. KG
Conditions
(from sponsor)		 Acute Coronary Syndrome
Related terms Acute Coronary Syndrome
Enrollment 490 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov