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NCT Number: NCT06543082

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHA Bundang Medical Center, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 (atazanavir, clarithromycin, darunavir/ritonavir, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, tipranavir/ritonavir) or P-glycoprotein inhibitors (cyclosporine, ranolazine).
  • Presence of any of the following concomitant conditions: 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 has a 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 (e.g., TNF-alpha inhibitors)
  • Patients with active infectious diseases

Treatment and study plan

Colchicine 0.6 mg

Drug

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.

Primary outcomes

  1. Efficacy Outcome: Net adverse clinical event

    Time frame: 12 months post-intervention

    The composite of cardiovascular death, nonfatal spontaneous (nonprocedural) myocardial infarction, nonfatal ischemic stroke, unplanned hospitalization leading to urgent revascularization, and major bleeding

  2. Safety Outcome: Stent thrombosis

    Time frame: 12 months post-intervention

    Definite, probable, or possible stent thrombosis according to the Academic Research Consortium

Secondary outcomes

  1. Cardiovascular death

    Time frame: 12 months post-intervention

    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.

  2. Nonfatal spontaneous (nonprocedural) myocardial infarction

    Time frame: 12 months post-intervention

    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.

  3. Nonfatal ischemic stroke

    Time frame: 12 months post-intervention

    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.

  4. Unplanned hospitalization leading to urgent revascularization

    Time frame: 12 months post-intervention

    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.

  5. Major bleeding

    Time frame: 12 months post-intervention

    Bleeding Academic Research Consortium type 3 or 5

  6. High residual inflammation

    Time frame: 1 month, 6 months, and 12 months post-intervention

    Participant with hs-CRP of ≥2 mg/L

  7. High residual platelet reactivity

    Time frame: 1 month and 12 months post-intervention

    Participant with P2Y12 reaction units of >208

  8. Low residual platelet reactivity

    Time frame: 1 month and 12 months post-intervention

    Participant with P2Y12 reaction units of <85

  9. Thrombogenicity

    Time frame: 1 month and 12 months post-intervention

    This will be measured using R, K, Angle, A10, MA, and Ly30 through thromboelastography.

  10. Adverse drug reaction to colchicine

    Time frame: 1 month, 3 months, 6 months, 9 months, and 12 months

    Response to a colchicine which is noxious and unintended and which occurs during the administration period.

Study contacts

Contact information is provided by the study sponsor or research team.

Hwa-In Kim

CONTACT

[email protected]

82-31-780-5858

Sponsors and collaborators

Lead sponsor

CHA University

Other

Collaborators

  • Biotronik SE & Co. KG

Registry information

Official study title

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

Acronym: MACT II

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 7, 2024
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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