A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction (REAL-TIMI 63B)

MedImmune

Status and phase: Completed; Phase 2

Conditions: ST Elevation Myocardial Infarction

Treatments: Biological: MEDI6012; Other: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03578809

D5780C00007

Details and patient eligibility

About

This is a Phase 2b randomized, blinded, placebo controlled study to evaluate the efficacy, safety, PK/pharmacodynamic, and immunogenicity of repeat doses of MEDI6012 in adult participants presenting with acute STEMI (ST segment elevation myocardial infarction).

The study will enrol participants presenting with acute STEMI who are planned for primary percutaneous coronary intervention (pPCI). For all participants, an end of study CMR will be performed at 10-12 weeks (70-84 days following Dose 1). A subset of participants will also undergo an index and an end of study CTA.

Enrollment: 593 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute STEMI (ST segment elevation myocardial infarction) diagnosed by ST elevation
• Planned for primary PCI (percutaneous coronary intervention)
• Men and women without child-bearing potential aged 30-80 years of age
• Capable and willing to provide informed consent.
• Capable of completing study visits

Exclusion criteria

• Fibrinolytic administration for index event
• Known prior MI or prior coronary artery bypass graft (CABG) surgery
• Known pre-existing cardiomyopathy
• History of anaphylaxis
• Suspected non-thrombotic etiology (ie, vasospasm, dissection, Takotsubo cardiomyopathy)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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593 participants in 4 patient groups, including a placebo group

Cohort A: Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to MEDI6012 on Day 1 prior to pPCI followed by a second inpatient dose on Day 3 by IV push.

Treatment:

Other: Placebo

Cohort A: MEDI6012

Experimental group

Description:

Participants will receive loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3 by IV push.

Treatment:

Biological: MEDI6012

Cohort B: Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to MEDI6012 on Day 1 prior to pPCI followed by a second inpatient dose on Day 3, and outpatient maintenance doses on Days 10, 17, 24, and 31 by IV push.

Treatment:

Other: Placebo

Cohort B: MEDI6012

Experimental group

Description:

Participants will receive loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3, and outpatient maintenance doses of MEDI6012 100 mg on Days 10, 17, 24, and 31 by IV push.

Treatment:

Biological: MEDI6012