A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction
REAL-TIMI 63B
A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction
1 other identifier
interventional
593
10 countries
37
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2018
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 5, 2018
CompletedFirst Submitted
Initial submission to the registry
June 8, 2018
CompletedFirst Posted
Study publicly available on registry
July 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2021
CompletedResults Posted
Study results publicly available
February 9, 2022
CompletedFebruary 9, 2022
January 1, 2022
2.6 years
June 8, 2018
January 13, 2022
January 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Global Infarct Size
Global infarct size expressed as a percentage of left ventricle (LV) mass measured on delayed-enhanced cardiovascular magnetic resonance (CMR) imaging in 10-12 weeks post myocardial infarction (MI) is reported.
70 to 84 days post Day 1 dose
Secondary Outcomes (9)
Left Ventricular Ejection Fraction (LVEF)
70 to 84 days post Day 1 dose
Change in Non-calcified Plaque Volume (NCPV) in the Coronary Arteries in Cohort B
Day 1 dose (48 to 72 hours post Dose 1) through 70 to 84 days post Day 1 dose
Left Ventricular Mass by Late Gadolinium Enhancement (LGE)
70 to 84 days post Day 1 dose
Left Ventricular Mass by Cine Magnetic Resonance Imaging (MRI)
70 to 84 days post Day 1 dose
Left Ventricular End-diastolic and End-systolic Volume
70 to 84 days post Day 1 dose
- +4 more secondary outcomes
Study Arms (4)
Cohort A: Placebo
PLACEBO COMPARATORParticipants will receive placebo matched to MEDI6012 on Day 1 prior to pPCI followed by a second inpatient dose on Day 3 by IV push.
Cohort A: MEDI6012
EXPERIMENTALParticipants 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.
Cohort B: Placebo
PLACEBO COMPARATORParticipants 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.
Cohort B: MEDI6012
EXPERIMENTALParticipants 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.
Interventions
MEDI6012
Placebo
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
- The TIMI Study Groupcollaborator
Study Sites (37)
Research Site
Belo Horizonte, 30110-934, Brazil
Research Site
Campinas, 13060-080, Brazil
Research Site
Porto Alegre, 90610-000, Brazil
Research Site
Porto Alegre, 90620-001, Brazil
Research Site
Brno, 65691, Czechia
Research Site
Hradec Králové, 500 05, Czechia
Research Site
Liberec, 46063, Czechia
Research Site
Pardubice, 53203, Czechia
Research Site
Prague, 10034, Czechia
Research Site
Prague, 12808, Czechia
Research Site
Ústí nad Labem, 40113, Czechia
Research Site
Budapest, 1122, Hungary
Research Site
Budapest, 1134, Hungary
Research Site
Beersheba, 8410101, Israel
Research Site
Haifa, 3109601, Israel
Research Site
Jerusalem, 9103102, Israel
Research Site
Jerusalem, 91120, Israel
Research Site
Petah Tikva, 4941492, Israel
Research Site
Ramat Gan, 5265601, Israel
Research Site
Tel Aviv, 6423906, Israel
Research Site
Alkmaar, 1815 JD, Netherlands
Research Site
Nijmegen, 6525 GA, Netherlands
Research Site
Nijmegen, 6532 SZ, Netherlands
Research Site
Bydgoszcz, 85-094, Poland
Research Site
Lodz, 90-549, Poland
Research Site
Lodz, 91-347, Poland
Research Site
Kazan', 420101, Russia
Research Site
Saint Petersburg, 197044, Russia
Research Site
Saint Petersburg, 197706, Russia
Research Site
Banská Bystrica, 974 01, Slovakia
Research Site
Nitra, 949 01, Slovakia
Research Site
Madrid, 28040, Spain
Research Site
Madrid, 28046, Spain
Research Site
Pontevedra, 36312, Spain
Research Site
Dundee, DD1 9SY, United Kingdom
Research Site
Leeds, LS13EX, United Kingdom
Research Site
Stevenage, SG1 4AB, United Kingdom
Related Publications (1)
Bonaca MP, Morrow DA, Bergmark BA, Berg DD, Lima JAC, Hoffmann U, Kato Y, Lu MT, Kuder J, Murphy SA, Spinar J, Oude Ophuis T, Kiss RG, Lopez-Sendon J, Averkov O, Wheatcroft SB, Kubica J, Carlos Nicolau J, Furtado RHM, Abuhatzira L, Hirshberg B, Omar SA, Vavere AL, Chang YT, George RT, Sabatine MS. Randomized, Placebo-Controlled Phase 2b Study to Evaluate the Safety and Efficacy of Recombinant Human Lecithin Cholesterol Acyltransferase in Acute ST-Segment-Elevation Myocardial Infarction: Results of REAL-TIMI 63B. Circulation. 2022 Sep 20;146(12):907-916. doi: 10.1161/CIRCULATIONAHA.122.059325. Epub 2022 Aug 30.
PMID: 36039762DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca Clinical Study Information Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- In this study, the participant and sponsor staff will be blinded. Sites will be trained to keep the investigator blinded. However, due to the acute nature of the study, members of the research team and, possibly, the investigator may be unblinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2018
First Posted
July 6, 2018
Study Start
June 5, 2018
Primary Completion
January 18, 2021
Study Completion
January 18, 2021
Last Updated
February 9, 2022
Results First Posted
February 9, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.