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 - CEL-03

Celecor Therapeutics Inc.0 个研究点目标入组 2,279 人开始时间: 2023年11月20日最近更新: 2024年7月22日

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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. If time of symptom onset is uncertain, the cardiologist may be contacted to confirm inclusion criteria., Enrollment by EFIC process, verbal witnessed/short written informed consent, or written informed consent signed by subject or legally authorized representative/independent witness, 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] according to local applicable legal regulations. 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.

•Cardiopulmonary resuscitation (CPR) for current out-of-hospital cardiac arrest (OHCA)., Participation in another clinical study with an investigational product or device within the past month, Life expectancy less than one year, Cardiogenic shock, presenting with systolic blood pressure <90 mmHg (confirmed on repeat assessment) and heart rate >100 beats per minute., Current known active COVID-19 infection (criteria according to local guidelines)., Currently treated with renal dialysis., Current treatment with oral anticoagulation (vitamin K antagonists* [VKAs] or direct oral anticoagulants** [DOACs]) 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

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