A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction (REAL-TIMI 63B)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03578809 |
Recruitment Status :
Completed
First Posted : July 6, 2018
Last Update Posted : February 26, 2021
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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 subjects presenting with acute STEMI (ST segment elevation myocardial infarction).
The study will enrol subjects presenting with acute STEMI who are planned for primary percutaneous coronary intervention (pPCI). For all subjects, an end of study CMR will be performed at 10-12 weeks (70-84 days following Dose 1). A subset of subjects will also undergo an index and an end of study CTA.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
ST Elevation Myocardial Infarction | Biological: MEDI6012 Other: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 595 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Masking Description: | In this study, the subject 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. |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction |
Actual Study Start Date : | June 5, 2018 |
Actual Primary Completion Date : | January 18, 2021 |
Actual Study Completion Date : | January 18, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort A
MEDI6012
|
Biological: MEDI6012
MEDI6012 |
Experimental: Cohort B
MEDI6012
|
Biological: MEDI6012
MEDI6012 |
Placebo Comparator: Placebo |
Other: Placebo
Placebo |
- Infarct size [ Time Frame: 10-12 weeks ]Infarct size as a percentage of LV mass measured on delayed-enhanced CMR imaging 10-12 weeks post-MI compared to placebo.
- Ejection Fraction [ Time Frame: 10-12 weeks ]EF measured by cine MRI at 10-12 weeks post-MI compared to placebo.
- Non Calcified Plaque Volume [ Time Frame: 10-12 weeks ]Change in NCPV in the coronary arteries from index CTA (Computed Tomography) to 10-12 weeks post-MI compared with placebo.
- Myocardial Mass [ Time Frame: 10-12 weeks ]Myocardial mass
- Adverse Events [ Time Frame: 0-12 weeks ]Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs).
- LCAT Mass [ Time Frame: 0-12 weeks ]LCAT (lecithin-cholesterol acyltransferase) mass
- Left Ventricular Volumes [ Time Frame: 10-12 Weeks ]LV (left ventricular) volumes at end-systole
- Incidence Rate of Immunogenicity [ Time Frame: 0-12 weeks ]Immunogenicity is measured by anti-drug antibodies (ADAs).
- Left Ventricular Volumes [ Time Frame: 10-12 weeks ]LV (left ventricular) volumes at end-diastole.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578809
Brazil | |
Research Site | |
Belo Horizonte, Brazil, 30110-934 | |
Research Site | |
Campinas, Brazil, 13060-080 | |
Research Site | |
Porto Alegre, Brazil, 90610-000 | |
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Porto Alegre, Brazil, 90620-001 | |
Czechia | |
Research Site | |
Brno, Czechia, 65691 | |
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Hradec Kralove, Czechia, 500 05 | |
Research Site | |
Liberec, Czechia, 46063 | |
Research Site | |
Pardubice, Czechia, 53203 | |
Research Site | |
Praha 10, Czechia, 10034 | |
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Praha 2, Czechia, 12808 | |
Research Site | |
Usti nad Labem, Czechia, 40113 | |
Hungary | |
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Budapest, Hungary, 1122 | |
Research Site | |
Budapest, Hungary, 1134 | |
Israel | |
Research Site | |
Beer Sheva, Israel, 8410101 | |
Research Site | |
Haifa, Israel, 3109601 | |
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Jerusalem, Israel, 9103102 | |
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Jerusalem, Israel, 91120 | |
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Petah Tikva, Israel, 4941492 | |
Research Site | |
Ramat Gan, Israel, 5265601 | |
Research Site | |
Tel Aviv, Israel, 6423906 | |
Netherlands | |
Research Site | |
Alkmaar, Netherlands, 1815 JD | |
Research Site | |
Nijmegen, Netherlands, 6525 GA | |
Research Site | |
Nijmegen, Netherlands, 6532 SZ | |
Poland | |
Research Site | |
Bydgoszcz, Poland, 85-094 | |
Research Site | |
Lodz, Poland, 90-549 | |
Research Site | |
Lodz, Poland, 91-347 | |
Russian Federation | |
Research Site | |
Kazan, Russian Federation, 420101 | |
Research Site | |
Saint Petersburg, Russian Federation, 197044 | |
Research Site | |
Saint Petersburg, Russian Federation, 197706 | |
Slovakia | |
Research Site | |
Banska Bystrica, Slovakia, 974 01 | |
Research Site | |
Nitra, Slovakia, 949 01 | |
Spain | |
Research Site | |
Madrid, Spain, 28040 | |
Research Site | |
Madrid, Spain, 28046 | |
Research Site | |
Pontevedra, Spain, 36312 | |
United Kingdom | |
Research Site | |
Dundee, United Kingdom, DD1 9SY | |
Research Site | |
Leeds, United Kingdom, LS13EX | |
Research Site | |
Stevenage, United Kingdom, SG1 4AB |
Responsible Party: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT03578809 |
Other Study ID Numbers: |
D5780C00007 |
First Posted: | July 6, 2018 Key Record Dates |
Last Update Posted: | February 26, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (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. |
URL: | https://astrazenecagroup-dt.pharmacm.com/DT/Home |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Myocardial Infarction ST Elevation Myocardial Infarction Infarction Ischemia Pathologic Processes |
Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |