EUCTR2023-000029-10-IT招募中1 期
De-Escalation of Antiplatelet Therapy to Evaluate Platelet Reactivity and Clinical Outcomes after Coronary Stenting in Patients at High Bleeding Risk and Recent Acute Coronary Syndrome: DESC-HBR trial - DESC-HBR
Azienda Ospedaliera Universitaria Gaetano Martino Messina0 个研究点目标入组 200 人开始时间: 2023年1月17日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Informed Consent signed and dated.
- •-Patients deemed at HBR according to standard definitions (i.e. PRECISE-DAPT =25 or HBR-ARC with at least 1 major or 2 minor criteria) (Table 1).
- •-Treated with PCI due to a recent ACS (i.e. unstable angina, non-ST segment elevated myocardial infarction or ST segment elevated myocardial infarction) 30 ±7 days earlier.
- •-Treated with DAPT with full-dose potent P2Y12 inhibitors (e.g. prasugrel 10mg or ticagrelor 90mg bid) according to international guidelines recommendations
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 160
排除标准
- •Known intolerance, hypersensitivity or contraindication (including active bleeding) to aspirin, clopidogrel, prasugrel or ticagrelor
- •Indication to oral anticoagulation
- •Indication to prolonged treatment with full-dose potent P2Y12 inhibitors (e.g. previous stent thrombosis, stenting of last remaining vessel, stent with indication for longer-term DAPT, perceived very high coronary ischemic risk etc.)
- •Any planned major surgery or interventional procedure requiring treatment modification
- •Prior transient ischemic attack, ischemic or haemorrhagic stroke
- •Severe hepatic insufficiency (Child-Pugh class C)
- •Ongoing therapy with strong CYP3A inducers or strong CYP3A inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir etc.)
- •Women who are pregnant or breast feeding or with potential to become pregnant during the course of the study (age < 55 years and last menstruation within the last 12 months) without a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices
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