EUCTR2016-003265-26-AT进行中（未招募）1 期
Pharmacokinetic/Pharmacodynamic effects of add-on antiplatelet therapy with parenteral cangrelor as compared to standard dual antiplatelet treatment in patients with ST-elevation myocardial infarction complicated by out-of-hospital cardiac arrest and treated with targeted temperature management – A Randomized Controlled Trial - Add-on Cangrelor in STEMI-triggered Cardiac Arrest
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age 18-74 years
- •Comatose survivors of OHCA
- •Estimated interval of <10 min from cardiac arrest to initiation of cardiopulmonary resuscitation (no-flow interval)
- •Interval of <60 min from initiation of cardiopulmonary resuscitation to ROSC (low-flow interval)
- •Initial shockable rhythm (i.e. ventricular fibrillation or pulseless ventricular tachycardia)
- •Application of TTM (32–34°C target temperature)
- •Diagnosis of ST elevation myocardial infarction (post-ROSC electrocardiography)
- •Scheduled for PCI
- •Eligible for treatment with standard loading doses of DAPT including acetylsalicylic acid and either prasugrel or ticagrelor
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Pregnant or breast-feeding patients
- •Body weight <60kg
- •Response to verbal commands after ROSC (thus not eligible for TTM)
- •Cardiac arrest due to trauma, exsanguination, strangulation, smoke inhalation, drug overdose, electrocution, hanging or drowning, or intracranial hemorrhage
- •Patients not achieving ROSC or subjected to an extracorporeal circulatory assist device
- •Acute treatment with P2Y12r inhibitor other than prasugrel or ticagrelor
- •Active bleeding or increased risk of bleeding because of irreversible coagulation disorders or due to recent major surgery/trauma or uncontrolled severe hypertension
- •Known history of ischemic or hemorrhagic stroke or transient ischemic attack (TIA)
- •Known history of severe hepatic impairment (Child Pugh C)
- •Known history of severe renal impairment (creatinine clearance <30mL/min)
- •Hypersensitivity to the active substance or to any of the excipients
- •Terminal illness present before cardiac arrest
- •Thrombolysis therapy
- •Scheduled for coronary bypass surgery (CABG)
- •Prior P2Y12r inhibitor use in the past 7 days
- •Prior vitamin K antagonists/NOACs use in past 7 days
- •Patients with known allergic reaction to P2Y12r inhibitors
研究者
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