A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarctio

Phase 1

• Conditions: ST-elevation myocardial infarction; MedDRA version: 20.0Level: LLTClassification code 10064345Term: ST segment elevation myocardial infarctionSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-004521-32-NL
• Lead Sponsor: MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-27
• Study Completion: 2021-01-18
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 593

Inclusion Criteria

1. Men and women without child-bearing potential aged 30-80 years of age who are capable and willing to provide informed consent.
2. Acute STEMI diagnosed by ST elevation (= 0.1 mV) in 2 contiguous leads
3. Planned for pPCI
4. Ischemic symptoms for = 6 hours
5. Capable of completing study visits
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 345
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 195

Exclusion Criteria

1. Pre-randomization cardiogenic shock or cardiopulmonary resuscitation
2. Fibrinolytic administration for index event
3. Known prior MI or prior coronary artery bypass graft (CABG) surgery
4. Known pre-existing cardiomyopathy
5. History of anaphylaxis
6. Suspected non-thrombotic etiology (ie, vasospasm, dissection, Takotsubo cardiomyopathy)
7. Other condition or severe illness that the investigator feels would limit the prognosis of the patient (eg, malignancy with life-expectancy < 3 months) or would make the patient otherwise unsuitable for enrollment (eg, pose a hazard or undue burden to the patient [known chronic renal or hepatic impairment, recent (< 30 days), cerebrovascular accident or transient ischemic attack] unable to complete study visits)
8. Known contraindication to MR imaging (eg, metallic implant, claustrophobia, implantable cardioverter-defibrillator (ICD), pacemaker, known Cr/Cl<30mL/min (Cockcroft Gault equation)
9. Pregnant women and/or breastfeeding women
10. Current or previous participation within last 30 days in a study using an investigational therapy or device.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified