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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03578809
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : November 18, 2019
Thrombolysis in Myocardial Infarction (TIMI) Study Group
Information provided by (Responsible Party):
MedImmune LLC

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 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
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Cohort A
Biological: MEDI6012

Experimental: Cohort B
Biological: MEDI6012

Placebo Comparator: Placebo Other: Placebo

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.

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

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)

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 identifier (NCT number): NCT03578809

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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479

  Show 55 Study Locations
Sponsors and Collaborators
MedImmune LLC
Thrombolysis in Myocardial Infarction (TIMI) Study Group

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Responsible Party: MedImmune LLC Identifier: NCT03578809     History of Changes
Other Study ID Numbers: D5780C00007
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019

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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
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases