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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 490
- 试验地点
- 9
- 主要终点
- Efficacy Outcome: Net adverse clinical event
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
MACT
Mono Antiplatelet and Colchicine Therapy
干预措施: Colchicine 0.6 mg (Drug)
结局指标
主要结局
Efficacy Outcome: Net adverse clinical event
时间窗: 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
Safety Outcome: Stent thrombosis
时间窗: 12 months post-intervention
Definite, probable, or possible stent thrombosis according to the Academic Research Consortium
次要结局
- High residual platelet reactivity(1 month and 12 months post-intervention)
- Unplanned hospitalization leading to urgent revascularization(12 months post-intervention)
- Adverse drug reaction to colchicine(1 month, 3 months, 6 months, 9 months, and 12 months)
- Nonfatal spontaneous (nonprocedural) myocardial infarction(12 months post-intervention)
- High residual inflammation(1 month, 6 months, and 12 months post-intervention)
- Low residual platelet reactivity(1 month and 12 months post-intervention)
- Thrombogenicity(1 month and 12 months post-intervention)
- Cardiovascular death(12 months post-intervention)
- Nonfatal ischemic stroke(12 months post-intervention)
- Major bleeding(12 months post-intervention)
研究者
Seung-Yul Lee
Associate Professor, Division of Cardiology, Department of Internal Medicine
CHA University