MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Efficacy Outcome: Net adverse clinical event [Срок оценки: 12 months post-intervention]
• Safety Outcome: Stent thrombosis [Срок оценки: 12 months post-intervention]

Вторичные конечные точки (10)

• Cardiovascular death [Срок оценки: 12 months post-intervention]
• Nonfatal spontaneous (nonprocedural) myocardial infarction [Срок оценки: 12 months post-intervention]
• Nonfatal ischemic stroke [Срок оценки: 12 months post-intervention]
• Unplanned hospitalization leading to urgent revascularization [Срок оценки: 12 months post-intervention]
• Major bleeding [Срок оценки: 12 months post-intervention]
• High residual inflammation [Срок оценки: 1 month, 6 months, and 12 months post-intervention]
• High residual platelet reactivity [Срок оценки: 1 month and 12 months post-intervention]
• Low residual platelet reactivity [Срок оценки: 1 month and 12 months post-intervention]
• Thrombogenicity [Срок оценки: 1 month and 12 months post-intervention]
• Adverse drug reaction to colchicine [Срок оценки: 1 month, 3 months, 6 months, 9 months, and 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 9 центров

• CHA Bundang Medical Center — Seongnam-si
• Keimyung University Dongsan Hospital — Daegu
• Wonkwang University Hospital — Iksan
• Myongji Hospital — Ilsan
• National Health Insurance Service Ilsan Hospital — Ilsan
• Seoul National University Bundang Hospital — Seongnam
• Ewha Womans University Seoul Hospital — Seoul
• Gangnam Severance Hospital — Seoul
• … и ещё 1 центр

Публикации

• 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
• 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
• 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;32 PMID 32543684
• 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 Sy PMID 37878786
• 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
• 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: 1 PMID 21670242
• 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. e PMID 41221450

Идентификаторы

NCT: NCT06543082 · CHAMC IRB 2024-01-057-009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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