Status:
ACTIVE_NOT_RECRUITING
A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI
Lead Sponsor:
CeleCor Therapeutics
Conditions:
ST-elevation Myocardial Infarction (STEMI)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a Phase 3 prospective, blinded, randomized, placebo controlled, international multicenter study. Subjects with STEMI will be enrolled in the ambulance if they meet all eligibility criteria. Th...
Detailed Description
Subjects will be screened in the ambulance based on the information available; those fulfilling the eligibility criteria who have provided verbal witnessed/short written/Exception from Informed Consen...
Eligibility Criteria
Inclusion
- 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 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 4 hours maximum. If time of symptom onset is uncertain, the cardiologist may be contacted to confirm inclusion criteria.
- Exception from Informed Consent Requirements (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, 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.
Exclusion
- Cardio Pulmonary Resuscitation (CPR) for current Out of Hospital Cardiac Arrest (OHCA).
- Presenting with systolic blood pressure \<90 mmHg (confirmed on repeat assessment) 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 \[VKA\], direct oral anticoagulants \[DOACs\]), or thrombolytic agents.
- 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.
- \-
Key Trial Info
Start Date :
April 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2026
Estimated Enrollment :
2463 Patients enrolled
Trial Details
Trial ID
NCT04825743
Start Date
April 24 2021
End Date
May 13 2026
Last Update
October 23 2025
Active Locations (45)
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1
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
2
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States, 48073
3
Washington University
St Louis, Missouri, United States, 63110
4
UT Southwestern Medical Center
Dallas, Texas, United States, 75390