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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 : Recruiting
First Posted : July 6, 2018
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 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 : January 12, 2021
Estimated Study Completion Date : January 12, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Cohort A
MEDI6012
Biological: MEDI6012
MEDI6012

Experimental: Cohort B
MEDI6012
Biological: MEDI6012
MEDI6012

Placebo Comparator: Placebo Other: Placebo
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.



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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 grafting
  • 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 ClinicalTrials.gov identifier (NCT number): NCT03578809


Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

  Show 53 Study Locations
Sponsors and Collaborators
MedImmune LLC
Thrombolysis in Myocardial Infarction (TIMI) Study Group

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT03578809     History of Changes
Other Study ID Numbers: D5780C00007
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases