Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03578809
Previous Study | Return to List | Next Study

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03578809
Recruitment Status : Completed
First Posted : July 6, 2018
Results First Posted : February 9, 2022
Last Update Posted : February 9, 2022
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 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.


Condition or disease Intervention/treatment Phase
ST Elevation Myocardial Infarction Biological: MEDI6012 Other: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 593 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: In this study, the participant 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

Arm Intervention/treatment
Placebo Comparator: Cohort A: Placebo
Participants will receive placebo matched to MEDI6012 on Day 1 prior to pPCI followed by a second inpatient dose on Day 3 by IV push.
Other: Placebo
Placebo
Other Name: 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.

Experimental: Cohort A: MEDI6012
Participants will receive loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3 by IV push.
Biological: MEDI6012
MEDI6012
Other Name: 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 Comparator: Cohort B: Placebo
Participants will receive placebo matched to MEDI6012 on Day 1 prior to pPCI followed by a second inpatient dose on Day 3, and outpatient maintenance doses on Days 10, 17, 24, and 31 by IV push.
Other: Placebo
Placebo
Other Name: 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.

Experimental: Cohort B: MEDI6012
Participants will receive loading dose of MEDI6012 300 mg on Day 1 prior to pPCI followed by a second inpatient dose of MEDI6012 150 mg on Day 3, and outpatient maintenance doses of MEDI6012 100 mg on Days 10, 17, 24, and 31 by IV push.
Biological: MEDI6012
MEDI6012
Other Name: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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.


Layout table for eligibility information
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)

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
Layout table for location information
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
  Study Documents (Full-Text)

Documents provided by MedImmune LLC:
Study Protocol  [PDF] May 4, 2020
Statistical Analysis Plan  [PDF] December 4, 2020

Additional Information:
Layout table for additonal information
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT03578809    
Other Study ID Numbers: D5780C00007
First Posted: July 6, 2018    Key Record Dates
Results First Posted: February 9, 2022
Last Update Posted: February 9, 2022
Last Verified: January 2022
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

Layout table for additional information
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:
Layout table for MeSH terms
Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases