MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study

NCT06543082 | Recruiting Phase 4 DMC

• 1 other identifier: CHAMC IRB 2024-01-057-009
• Study Type: interventional
• Target: 490
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Acute Coronary Syndrome

Keywords

Colchicine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Cardiovascular death

  12 months post-intervention

• Nonfatal spontaneous (nonprocedural) myocardial infarction

  12 months post-intervention

• Nonfatal ischemic stroke

  12 months post-intervention

• Unplanned hospitalization leading to urgent revascularization

  12 months post-intervention

• Major bleeding

  12 months post-intervention

Study Arms (1)

MACT

EXPERIMENTAL

Mono Antiplatelet and Colchicine Therapy

Drug: Colchicine 0.6 mg

Interventions

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.

MACT

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• CHA University: lead
• Biotronik SE & Co. KG: collaborator

Study Sites (9)

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

RECRUITING

Keimyung University Dongsan Hospital

Daegu, South Korea

RECRUITING

Wonkwang University Hospital

Iksan, South Korea

RECRUITING

Myongji Hospital

Ilsan, South Korea

RECRUITING

National Health Insurance Service Ilsan Hospital

Ilsan, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam, South Korea

RECRUITING

Ewha Womans University Seoul Hospital

Seoul, South Korea

RECRUITING

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

Wonju Severance Christian Hospital

Wŏnju, South Korea

RECRUITING

Related Publications (7)

• Lee SY, Jeong YH, Yun KH, Cho JY, Gorog DA, Angiolillo DJ, Kim JW, Jang Y. P2Y12 Inhibitor Monotherapy Combined With Colchicine Following PCI in ACS Patients: The MACT Pilot Study. JACC Cardiovasc Interv. 2023 Aug 14;16(15):1845-1855. doi: 10.1016/j.jcin.2023.05.035.

  PMID: 37587591 BACKGROUND

• Lee SY, Cho JY, Gorog DA, Angiolillo DJ, Yun KH, Ahn JH, Koh JS, Park Y, Hwang SJ, Hwang JY, Kim JW, Jang Y, Jeong YH. Inflammation and platelet reactivity during adjunctive colchicine versus aspirin in patients with acute coronary syndrome treated with potent P2Y12 inhibitor. Front Med (Lausanne). 2024 Apr 19;11:1349577. doi: 10.3389/fmed.2024.1349577. eCollection 2024.

  PMID: 38841588 BACKGROUND

• Kim BK, Hong SJ, Cho YH, Yun KH, Kim YH, Suh Y, Cho JY, Her AY, Cho S, Jeon DW, Yoo SY, Cho DK, Hong BK, Kwon H, Ahn CM, Shin DH, Nam CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y; TICO Investigators. Effect of Ticagrelor Monotherapy vs Ticagrelor With Aspirin on Major Bleeding and Cardiovascular Events in Patients With Acute Coronary Syndrome: The TICO Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2407-2416. doi: 10.1001/jama.2020.7580.

  PMID: 32543684 BACKGROUND

• Hong SJ, Lee SJ, Suh Y, Yun KH, Kang TS, Shin S, Kwon SW, Lee JW, Cho DK, Park JK, Bae JW, Kang WC, Kim S, Lee YJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK; T-PASS (Ticagrelor Monotherapy in Patients Treated With New-Generation Drug-Eluting Stents for Acute Coronary Syndrome) Investigators. Stopping Aspirin Within 1 Month After Stenting for Ticagrelor Monotherapy in Acute Coronary Syndrome: The T-PASS Randomized Noninferiority Trial. Circulation. 2024 Feb 20;149(8):562-573. doi: 10.1161/CIRCULATIONAHA.123.066943. Epub 2023 Oct 25.

  PMID: 37878786 BACKGROUND

• Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.

  PMID: 17470709 BACKGROUND

• Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

  PMID: 21670242 BACKGROUND

• Jang JY, Suh Y, Kim C, Byoun JT, Yun KH, Lee JH, Jeon KH, Cho S, Yoon HJ, Kim JW, Lee B, Kang SH, Kim SH, Moon JY, Jang Y, Lee SY. Efficacy and safety of mono antiplatelet therapy with colchicine in acute coronary syndrome patients following percutaneous coronary intervention: rationale and design of the MACT II trial. Front Cardiovasc Med. 2025 Oct 27;12:1662392. doi: 10.3389/fcvm.2025.1662392. eCollection 2025.

  PMID: 41221450 DERIVED

Related Links

• The MACT Pilot Study

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Seung-Yul Lee, MD

  CHA Bundang Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hwa-In Kim

CONTACT

82-31-780-5858; niawhz23@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Division of Cardiology, Department of Internal Medicine

Study Record Dates

• First Submitted: August 3, 2024
• First Posted: August 7, 2024
• Study Start: August 5, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (9)