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Completed

NCT Number: NCT03578809

A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction

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.

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Key information

Conditions

ST Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Belo Horizonte, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MEDI6012

Biological

MEDI6012

Other names: MEDI6012 300 mg will be administered on Day 1 and MEDI6012 150 mg on Day 3 by IV push in Cohorts A and B. In Cohort B, MEDI6012 100 mg will be administered on Days 10, 17, 24, and 31 by IV push.

Placebo

Other

Placebo

Other names: Placebo matched to MEDI6012 will be administered on Day 1 and Day 3 by IV push in Cohorts A and B, and on Days 10, 17, 24, and 31 by IV push in Cohort B.

Primary outcomes

  1. Global Infarct Size

    Time frame: 70 to 84 days post Day 1 dose

    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.

Secondary outcomes

  1. Left Ventricular Ejection Fraction (LVEF)

    Time frame: 70 to 84 days post Day 1 dose

    The LVEF measured by cine magnetic resonance imaging (MRI) at 10-12 weeks post-MI is reported.

  2. Change in Non-calcified Plaque Volume (NCPV) in the Coronary Arteries in Cohort B

    Time frame: Day 1 dose (48 to 72 hours post Dose 1) through 70 to 84 days post Day 1 dose

    Change in NCPV in the coronary arteries from index computed tomography angiography (CTA) to 10-12 weeks post-MI is reported. The index CTA was preferably to be performed between 48 to 72 hours post Dose 1 (could be done up to 5 days post Dose 1) but no earlier than 40 hours post Dose 1. Participants with creatinine clearance >= 60 mL/min (Cockcroft Gault equation) within 6 hours underwent an index coronary CTA no earlier than 40 hours following the first dose.

  3. Left Ventricular Mass by Late Gadolinium Enhancement (LGE)

    Time frame: 70 to 84 days post Day 1 dose

    The left ventricular mass by LGE is reported.

  4. Left Ventricular Mass by Cine Magnetic Resonance Imaging (MRI)

    Time frame: 70 to 84 days post Day 1 dose

    The left ventricular mass by cine MRI is reported.

  5. Left Ventricular End-diastolic and End-systolic Volume

    Time frame: 70 to 84 days post Day 1 dose

    Left ventricular end-diastolic and end-systolic volume is reported.

  6. Left Ventricular End-diastolic and End-systolic Volume Index

    Time frame: 70 to 84 days post Day 1 dose

    Left ventricular end-diastolic and end-systolic volume index is reported.

  7. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

    Time frame: Day 1 through Day 195 post Day 1 dose

    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

  8. Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass)

    Time frame: Pre- and post-dose on Days 1, 3, 17, and 31

    Serum concentration of MEDI6012 is reported.

  9. Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012

    Time frame: Predose on Day 1, Day 17, Day 31, 70 to 84 days, and on Day 195 post Day 1 dose

    Number of participants with positive ADA titer to MEDI6012 are reported in 3 categories, ADA positive at any visit up to Day 70-84 follow-up visit, ADA positive with > 30% decrease in HDL-C from baseline (on the same date) at any visit up to D70-84 FU V, and ADA positive and > 30% decrease in HDL-C from baseline at Day 70-84 Follow-up Visit.

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Collaborators

  • The TIMI Study Group

Registry information

Official study title

A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction

Acronym: REAL-TIMI 63B

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 6, 2018
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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