MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study (MACT II)

February 15, 2026 updated by: Seung-Yul Lee, CHA University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

490

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Daegu, South Korea
        • Recruiting
        • Keimyung University Dongsan Hospital
        • Contact:
      • Iksan, South Korea
        • Recruiting
        • Wonkwang University Hospital
        • Contact:
      • Ilsan, South Korea
        • Recruiting
        • National Health Insurance Service Ilsan Hospital
        • Contact:
      • Ilsan, South Korea
        • Recruiting
        • Myongji Hospital
        • Contact:
      • Seongnam, South Korea
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Ewha Womans University Seoul Hospital
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Gangnam Severance Hospital
        • Contact:
      • Wŏnju, South Korea
        • Recruiting
        • WonJu Severance Christian Hospital
        • Contact:
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13496
        • Recruiting
        • CHA Bundang Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MACT
Mono Antiplatelet and Colchicine Therapy
Drug: Colchicine 0.6 mg
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months post-intervention
Safety Outcome: Stent thrombosis
Time Frame: 12 months post-intervention
Definite, probable, or possible stent thrombosis according to the Academic Research Consortium
12 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months post-intervention
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.
12 months post-intervention
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.
12 months post-intervention
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.
12 months post-intervention
Major bleeding
Time Frame: 12 months post-intervention
Bleeding Academic Research Consortium type 3 or 5
12 months post-intervention
High residual inflammation
Time Frame: 1 month, 6 months, and 12 months post-intervention
Participant with hs-CRP of ≥2 mg/L
1 month, 6 months, and 12 months post-intervention
High residual platelet reactivity
Time Frame: 1 month and 12 months post-intervention
Participant with P2Y12 reaction units of >208
1 month and 12 months post-intervention
Low residual platelet reactivity
Time Frame: 1 month and 12 months post-intervention
Participant with P2Y12 reaction units of <85
1 month and 12 months post-intervention
Thrombogenicity
Time Frame: 1 month and 12 months post-intervention
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
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.
1 month, 3 months, 6 months, 9 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHA University

Collaborators

Biotronik SE & Co. KG

Investigators

  • Principal Investigator: Seung-Yul Lee, MD, CHA Bundang Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 3, 2024

First Submitted That Met QC Criteria

August 3, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 15, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHAMC IRB 2024-01-057-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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