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

CeleCor Therapeutics, Inc.0 个研究点目标入组 2,499 人开始时间: 2020年9月2日最近更新: 2024年4月15日

适应症

试验速览

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•- 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

•- Cardiopulmonary Resuscitation for current Out of Hospital Cardiac Arrest.
•- Cardiogenic shock presenting with systolic blood pressure <90 mmHg confirmed on repeat testing and heart rate >100 beats per minute.
•- 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 example.
•* 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.

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