EUCTR2020-003320-16-CZ进行中（未招募）1 期
A Phase 3 prospective, blinded, randomized, placebo controlled,international multicenter study to assess the safety and efficacy of a singlesubcutaneous injection of zalunfiban in subjects with ST-elevationmyocardial infarction in the pre-hospital setting - CELEBRATE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,499
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
- •- Planned transport to participating clinical site
- •- Males aged =18 years or post-menopausal or surgically sterile females =50 years or =55 years (for Czech Republic study sites only).
- •- Weight (by history) between 52 and 130 kg (115 and 287 lb).
- •- Subjects with documented STEMI, presenting with persistent ischemic chest pain (>10 minutes) and new =2 mm ST-segment elevation in 2 adjacent ECG leads, in whom the total duration of symptoms to diagnostic ECG is 4 hours maximum.
- •- Enrollment by EFIC process, verbal witnessed/short written informed consent, or written informed consent will be obtained in the acute phase by (para)medics [Romania and other select sites with the sponsor's approval: clinical site personnel, if greater than 30 minutes of delay is anticipated for
- •door-to-balloon time]. Subject is willing and able to give informed consent. Written informed consent will be obtained as soon as the subject's clinical condition allows it.
- •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 1000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1499
排除标准
- •- Cardio Pulmonary Resuscitation (CPR) for current Out of Hospital Cardiac Arrest (OHCA).
- •- Cardiogenic shock 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 or direct oral anticoagulants **) and thrombolytic agents***. For
- •* acenocoumarol or phenprocoumon, fluindione, and Coumadin (warfarin)
- •** dabigatran, apixaban, edoxaban, rivaroxaban and betrixaban
- •*** tenecteplase, alteplase, reteplase, streptokinase, and urokinase
- •- 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).
- •- Previously enrolled in this study.
- •- Participation in another clinical study with an investigational product or device within the past month.
- •- Life expectancy less than one year.
研究者
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