NL-OMON56301招募中3 期
A Phase 3 prospective, blinded, randomized, placebo controlled, international multicenter study to assess the safety and efficacy of a single subcutaneous injection of zalunfiban in subjects with ST-elevation myocardial infarction in the pre-hospital setting - CELEBRATE
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,619
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
- 年龄范围
- 18 至 99（—）
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.
- •- 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 is 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.
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 and heart
- •rate >100 beats per minute (bpm).
- •- Current active coronavirus disease 2019 (COVID-19) infection (criteria
- •according to local guidelines).
- •- Currently treated with dialysis.
- •- Current oral anticoagulation (Vitamin K antagonists* or direct oral
- •anticoagulants**) and thrombolytic agents***. For example
- •* acenocoumarol or phenprocoumon; and Coumadin (warfarin)
- •** dabigatran, apixaban, edoxaban, rivaroxaban, and betrixaban
- •*** tenecteplase, alteplase, reteplase, streptokinase, and urokinase
- •- Surgery, 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.
- •device within the past month.
- •- Life expectancy less than one year.
研究者
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