A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction - REAL-TIMI 63B
Study identifier:D5780C00007
ClinicalTrials.gov identifier:NCT03578809
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction
Medical condition
ST Elevation Myocardial Infarction
Phase
Phase 2
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
594
Study type
Interventional
Age
30 Years - 80 Years
Date
Study Start Date: 05 Jun 2018
Primary Completion Date: 18 Jan 2021
Study Completion Date: 18 Jan 2021
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2022 by MedImmune, LLC
Sponsors
MedImmune, LLC
Collaborators
Thrombolysis in Myocardial Infarction (TIMI) Study Group
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Cohort A: Placebo 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. | Other: Placebo Placebo Other Name: Placebo matched to MEDI6012 will be administered on Day 1 and Day 3 by IV push in Cohorts A and B, and on Days 10, 17, 24, and 31 by IV push in Cohort B. |
| Experimental: Cohort A: MEDI6012 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. | Biological/Vaccine: MEDI6012 MEDI6012 Other Name: MEDI6012 300 mg will be administered on Day 1 and MEDI6012 150 mg on Day 3 by IV push in Cohorts A and B. In Cohort B, MEDI6012 100 mg will be administered on Days 10, 17, 24, and 31 by IV push. |
| Placebo Comparator: Cohort B: Placebo 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. | Other: Placebo Placebo Other Name: Placebo matched to MEDI6012 will be administered on Day 1 and Day 3 by IV push in Cohorts A and B, and on Days 10, 17, 24, and 31 by IV push in Cohort B. |
| Experimental: Cohort B: MEDI6012 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. | Biological/Vaccine: MEDI6012 MEDI6012 Other Name: MEDI6012 300 mg will be administered on Day 1 and MEDI6012 150 mg on Day 3 by IV push in Cohorts A and B. In Cohort B, MEDI6012 100 mg will be administered on Days 10, 17, 24, and 31 by IV push. |
