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

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ClinicalTrials.gov Identifier: NCT03578809
Recruitment Status : Completed
First Posted : July 6, 2018
Last Update Posted : February 26, 2021
Sponsor:
Collaborator:
Thrombolysis in Myocardial Infarction (TIMI) Study Group
Information provided by (Responsible Party):
MedImmune LLC

Study Description
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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 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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort A
MEDI6012
 Biological: MEDI6012
MEDI6012
Experimental: Cohort B
MEDI6012
 Biological: MEDI6012
MEDI6012
Placebo Comparator: Placebo Other: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Ejection Fraction [ Time Frame: 10-12 weeks ]
    EF measured by cine MRI at 10-12 weeks post-MI compared to placebo.

  2. 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.

  3. Myocardial Mass [ Time Frame: 10-12 weeks ]
    Myocardial mass

  4. Adverse Events [ Time Frame: 0-12 weeks ]
    Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs).

  5. LCAT Mass [ Time Frame: 0-12 weeks ]
    LCAT (lecithin-cholesterol acyltransferase) mass

  6. Left Ventricular Volumes [ Time Frame: 10-12 Weeks ]
    LV (left ventricular) volumes at end-systole

  7. Incidence Rate of Immunogenicity [ Time Frame: 0-12 weeks ]
    Immunogenicity is measured by anti-drug antibodies (ADAs).

  8. Left Ventricular Volumes [ Time Frame: 10-12 weeks ]
    LV (left ventricular) volumes at end-diastole.


Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Brazil
Research Site
Belo Horizonte, Brazil, 30110-934
Research Site
Campinas, Brazil, 13060-080
Research Site
Porto Alegre, Brazil, 90610-000
Research Site
Porto Alegre, Brazil, 90620-001
Czechia
Research Site
Brno, Czechia, 65691
Research Site
Hradec Kralove, Czechia, 500 05
Research Site
Liberec, Czechia, 46063
Research Site
Pardubice, Czechia, 53203
Research Site
Praha 10, Czechia, 10034
Research Site
Praha 2, Czechia, 12808
Research Site
Usti nad Labem, Czechia, 40113
Hungary
Research Site
Budapest, Hungary, 1122
Research Site
Budapest, Hungary, 1134
Israel
Research Site
Beer Sheva, Israel, 8410101
Research Site
Haifa, Israel, 3109601
Research Site
Jerusalem, Israel, 9103102
Research Site
Jerusalem, Israel, 91120
Research Site
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
Sponsors and Collaborators
MedImmune LLC
Thrombolysis in Myocardial Infarction (TIMI) Study Group
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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

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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
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases