Short-Term Dual Antiplatelet Therapy With Early Transition to Low-dose Antiplatelet Monotherapy Using ticagRelor in Chronic Coronary Artery Disease
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Composite of cardiovascular death, myocardial infarction, disabling stroke, target lesion revascularization, major bleeding, and all-cause death
研究概览
简要总结
This is a prospective, multicenter, randomized, open-label trial with blinded endpoint adjudication (PROBE design), comparing one-month dual antiplatelet therapy (DAPT) with low-dose ticagrelor (60 mg BID) followed by ticagrelor monotherapy to standard 6-month DAPT with aspirin and clopidogrel in patients with chronic coronary syndrome (CCS) undergoing percutaneous coronary intervention (PCI). The primary endpoint is a composite of cardiovascular death, all-cause death, myocardial infarction, disabling stroke, target lesion revascularization (TLR), and major bleeding. The study aims to evaluate whether the short DAPT strategy reduces ischemic events while maintaining bleeding safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years at the time of informed consent.
- •Diagnosis of chronic coronary syndrome (CCS) according to ESC guidelines.
- •Undergoing successful PCI with implantation of one or more new-generation drug-eluting stents (DES).
- •Indication for dual antiplatelet therapy (DAPT) following PCI.
- •Willingness and ability to comply with all study procedures and follow-up assessments.
- •Signed informed consent prior to any study-specific procedure.
- •Creatinine clearance ≥30 mL/min, calculated using the Cockcroft-Gault formula.
- •Life expectancy greater than 1 year in the investigator's judg-ment.
- •Hemodynamically stable at the time of randomization.
- •Acceptable bleeding risk profile: patients fulfilling ARC-HBR criteria may be included only if the treating physician deems a 6-month antiplatelet regimen to be safe.
- •No contraindications to study drugs, including aspirin, clopi-dogrel, or ticagrelor.
排除标准
- •Presentation with acute coronary syndrome (ACS), including STEMI, NSTEMI, or unstable angina within the previous 6 mon-ths.
- •Planned staged PCI or revascularization procedure within 6 months after index PCI.
- •Requirement for long-term oral anticoagulation therapy, such as for atrial fibrillation, mechanical heart valves, or venous thromboembolism.
- •History of major bleeding, including gastrointestinal or intra-cranial bleeding, within the past 6 months.
- •Severe hepatic impairment, active liver disease, or transamina-ses >3× upper limit of normal.
- •Known platelet disorder, coagulopathy, or thrombocytopenia (<100,000/mm³).
- •Contraindication or hypersensitivity to aspirin, clopidogrel, or ticagrelor, or known drug interaction that precludes their use.
- •Ongoing active bleeding or high risk of bleeding that, in the opinion of the investigator, precludes DAPT.
- •Pregnancy or breastfeeding, or women of childbearing potential who are not using effective contraception.
- •Life expectancy <1 year due to non-cardiovascular comorbidi-ties (e.g., cancer, advanced renal failure).
- •Participation in another interventional clinical trial that may interfere with the outcomes of this study.
- •Severe anemia (hemoglobin <9 g/dL) not corrected before ran-domization.
- •Inability or unwillingness to provide informed consent or ad-here to study follow-up.
- •Prior stroke with residual neurological deficit or history of di-sabling stroke (mRS ≥3).
研究组 & 干预措施
Standard DAPT with Clopidogrel
- 6-month DAPT: aspirin + clopidogrel 75 mg daily
干预措施: clopidogrel 75 mg (Drug)
Short DAPT with Ticagrelor 60 mg
- 1-month DAPT: aspirin + ticagrelor 60 mg BID
- Followed by 5-month ticagrelor 60 mg BID monotherapy
- Ticagrelor will be provided by the sponsor (off-label use)
干预措施: Ticagrelor 60 mg (Drug)
结局指标
主要结局
Composite of cardiovascular death, myocardial infarction, disabling stroke, target lesion revascularization, major bleeding, and all-cause death
时间窗: 6 month
Number of participants experiencing any of the following events within 12 months after the index percutaneous coronary intervention (PCI): * Cardiovascular death - Number of participants with death due to a cardiovascular cause * Non-fatal myocardial infarction - Number of participants with myocardial infarction as defined by the Fourth Universal Definition * Non-fatal disabling stroke - Number of participants with stroke resulting in a modified Rankin Scale (mRS) ≥2 * Target lesion revascularization (TLR) - Number of participants undergoing clinically driven revascularization of the target lesion * Major bleeding - Number of participants experiencing major bleeding events defined as BARC type 3 or 5 * All-cause death - Number of participants who died from any cause
次要结局
- Cardiovascular Death(6 month)
- All cause death(6 month)
- Myocardial Infarction(6 month)
- Major Bleeding (BARC ≥3)(6 month)
- Disabling Stroke(6 month)
- Target Lesion Revascularization (TLR)(6 month)
- Target Vessel Revascularization (TVR)(6 month)
- Any Ischemic Event(6 month)
研究者
Rodolfo Caminiti
Principal Investigator, Interventional Cardiologist
University of Messina