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| Name | Class |
|---|---|
| Biotronik SE & Co. KG | INDUSTRY |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MACT | Experimental | Mono Antiplatelet and Colchicine Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular death | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hwa-In Kim | Contact | 82-31-780-5858 | niawhz23@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Seung-Yul Lee, MD | CHA Bundang Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center | Recruiting | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37587591 | Background | 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. | |
| 38841588 | 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. |
| Label | URL |
|---|---|
| The MACT Pilot Study | View source |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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|
| 12 months post-intervention |
| Nonfatal spontaneous (nonprocedural) myocardial infarction | 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 | 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 | 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 | Bleeding Academic Research Consortium type 3 or 5 | 12 months post-intervention |
| High residual inflammation | Participant with hs-CRP of ≥2 mg/L | 1 month, 6 months, and 12 months post-intervention |
| High residual platelet reactivity | Participant with P2Y12 reaction units of >208 | 1 month and 12 months post-intervention |
| Low residual platelet reactivity | Participant with P2Y12 reaction units of <85 | 1 month and 12 months post-intervention |
| Thrombogenicity | 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 | 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 |
| Keimyung University Dongsan Hospital | Recruiting | Daegu | South Korea |
|
| Wonkwang University Hospital | Recruiting | Iksan | South Korea |
|
| Myongji Hospital | Recruiting | Ilsan | South Korea |
|
| National Health Insurance Service Ilsan Hospital | Recruiting | Ilsan | South Korea |
|
| Seoul National University Bundang Hospital | Recruiting | Seongnam | South Korea |
|
| Ewha Womans University Seoul Hospital | Recruiting | Seoul | South Korea |
|
| Gangnam Severance Hospital | Recruiting | Seoul | South Korea |
|
| Wonju Severance Christian Hospital | Recruiting | Wŏnju | South Korea |
|
| 32543684 | 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. |
| 37878786 | 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. |
| 17470709 | 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. |
| 21670242 | 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. |
| 41221450 | Derived | 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. |