EUCTR2020-003320-16-HU进行中（未招募）1 期
A Phase 2B prospective, blinded, randomized, placebo controlled, international multicenter study to assess restoration of coronary artery blood flow and resolution of ST segment deviation after a single subcutaneous injection of RUC-4 in subjects with ST-elevation myocardial infarction presenting in the ambulance (pre-hospital setting) - CELEBRATE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,668
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
- •Males aged =18 years or post-menopausal or surgically sterile females =50 years.
- •? Weight (by history) between 52 and 130 kg.
- •? Subjects with STEMI, presenting with persistent ischemic chest pain (>10 minutes) and new =2 mm ST-segment elevation in two adjacent ECG leads, in whom the total duration of symptoms is anticipated to be within 4 hours.
- •? Verbal witnessed / short written informed consent will be obtained in the acute phase by highly trained paramedics. After the PCI/angiography procedure written informed consent will be obtained.
- •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 667
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1001
排除标准
- •Cardio Pulmonary Resuscitation (CPR) for current Out of Hospital Cardiac Arrest (OHCA), except successful intervention for Ventricular Fibrillation (VF) with return of consciousness.
- •? Presenting with systolic blood pressure <90 mmHg confirmed on repeat testing and heart rate >100 beats per minute (bpm).
- •? Current known active coronavirus disease 2019 (COVID-19) infection (criteria according to local guidelines.
- •? Currently treated with renal dialysis.
- •? Current treatment with oral anticoagulation (Vitamin K antagonists [VKA] or direct oral anticoagulants [DOACs]).
- •? Major surgery, or trauma or bleeding leading to hospitalization, within the past month.
- •? Known history of ischemic or hemorrhagic stroke.
- •? Known severe anemia (regular blood transfusion needed).
- •? Participation in another clinical study with an investigational product or device within the past month.
研究者
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