2023-507545-28-00招募中4 期
Safety and efficacy of very short dual antiplatelet therapy followed by P2Y12 inhibitor monotherapy in older patients undergoing percutaneous coronary intervention.
Centre Hospitalier Universitaire De Caen Normandie15 个研究点 分布在 1 个国家目标入组 1,700 人开始时间: 2025年3月27日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,700
- 试验地点
- 15
- 主要终点
- Net clinical benefit (a composite of all-cause death, myocardial infarction, stroke, and major bleeding defined as BARC grade 3 or 5) non-inferiority at 1 year, H01 BARC=Bleeding Academic Research Consortium
研究概览
简要总结
To determine whether short DAPT (dual antiplatelet therapy) followed by SAPT (single antiplatelet therapy) with P2Y12 inhibitor is non-inferior to standard DAPT regarding net clinical benefit (a composite of all-cause death, myocardial infarction, stroke and major bleeding BARC 3 or 5) at 1 year in elderly patients undergoing PCI
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 65 years
- •Successfully treated with percutaneous coronary intervention (PCI) with ≥ 1 drug-eluting stent (final TIMI 3 flow and visually estimated residual diameter stenosis <30%) for acute coronary syndrome (including ST-elevation myocardial infarction, non-ST-elevation myocardial infarction and unstable angina) or chronic coronary syndrome (elective PCI). Inclusion is possible after the last PCI procedure in staged procedure.
- •Randomization must be performed before the discharge from the study site.
- •Written informed consent
- •Social security affiliated
排除标准
- •PCI without drug-eluting stent implantation or with a bioresorbable scaffold
- •Known hypersensitivity or allergy to aspirin, clopidogrel, ticagrelor or prasugrel
- •Use of fibrinolytic therapy within 24 hours of PCI
- •Severe renal insufficiency (MDRD creatinine clearance < 30 ml/min/m2) and/or dialysis
- •Increased bleeding risk (prior hemorrhagic stroke; stroke < 30 days; brain injury<6 months; history of intracranial tumor or intracranial hemorrhage; internal bleeding<6 weeks; active bleeding; anemia (hemoglobin ≤ 8 g/dl) or thrombocytopenia (platelets < 100 000 G/L); major surgery<3 weeks)
- •patients with poor quality of the downstream territory with diffuse distal coronary disease
- •women of childbearing potential: non menopaused -with no menses for 12 months without an alternative medical cause- and not permanently sterilized -hystercetomy, bilateral salpingectomy or bilateral oophorectomy
- •increased thrombotic risk related to the patient (previous stent thrombosis, ≥ 2 previous myocardial infarction, symptomatic peripheral artery disease, chronic systemic inflammatory disease treated with corticoids or immunosuppressive drug) or the procedure (left main treated, ≥3 stents/treated lesions, total length of stents>60mm, bifurcation lesion with stents in each branch, stenting of the last patent vessel)
- •Life expectancy less than 1 year
- •Participation in another interventional trial
- •Patients considered as vulnerable by the investigators because of medical, psychological or social conditions: ▪ Patients with known or discovered severe cognitive impairment ▪ Patients with treated or untreated severe psychological or psychiatric conditions ▪ Patients with uncorrected severe hearing or visual handicap ▪ Patients with addictive alcohol, drug or substance abuse ▪ Patients with protective measures (guardianship, tutorship, curatorship) ▪ Any other condition considered by the investigators as not warranting informed consent
- •Planned coronary artery bypass grafting or cardiac surgery
- •Any planned surgery within 12 months unless intended antiplatelet therapy could be maintained throughout the peri-surgical period
- •Index PCI for stent thrombosis or chronic total occlusion
- •Need for oral anticoagulation therapy
结局指标
主要结局
Net clinical benefit (a composite of all-cause death, myocardial infarction, stroke, and major bleeding defined as BARC grade 3 or 5) non-inferiority at 1 year, H01 BARC=Bleeding Academic Research Consortium
Net clinical benefit (a composite of all-cause death, myocardial infarction, stroke, and major bleeding defined as BARC grade 3 or 5) non-inferiority at 1 year, H01 BARC=Bleeding Academic Research Consortium
次要结局
- - cardiovascular death (ARC-2 definition)
- - Intracranial bleeding defined by NeuroARC type 1.a.H, 1.b, 1.c hemorrhagic CNS injury
- - all-cause death
- - myocardial infarction type 1, 3 or 4b (type 4b defined according ARC-2 definition)
- - any stroke
- 1) Major or clinically relevant non-major bleeding (BARC 2, 3 or 5) non-inferiority, H02
- - net clinical benefit (a composite of all-cause death, myocardial infarction, stroke, and major bleeding defined as BARC grade 3 or 5) evaluated as superior or not
- - stent thrombosis (definite or probable, ARC-2 definition)
- - All-cause hospitalization
- - Urgent/unplanned symptoms-driven coronary revascularization
- Evaluation criteria of the study are hemorrhagic or thrombotic safety criteria related to the antiplatelet strategies.
- 2) Major or clinically relevant non-major bleeding (BARC 2, 3 or 5) superiority, H03
- 3) Major cardiovascular and cerebrovascular events (a composite of all-cause death, myocardial infarction and stroke) non-inferiority, H04
- 4) Major bleeding (BARC 3 or 5) superiority, H05
研究者
Investigateur coordinateur
Scientific
Centre Hospitalier Universitaire De Caen Normandie
研究点 (15)
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