EUCTR2017-004521-32-SKActive, not recruitingPhase 1
A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction - REAL-TIMI 63B
MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC0 sites414 target enrollmentStarted: April 17, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 414
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 primary PCI
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 114
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 grafting
- •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 eGFR<30 mL/min/1.73m2)
- •9. Pregnant women
Investigators
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