A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction
NCT ID: NCT03578809
Last Updated: 2022-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
593 participants
INTERVENTIONAL
2018-06-05
2021-01-18
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Placebo
Placebo
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.
MEDI6012
MEDI6012
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.
Placebo
Placebo
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.
MEDI6012
MEDI6012
Interventions
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MEDI6012
MEDI6012
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
30 Years
80 Years
ALL
No
Sponsors
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The TIMI Study Group
OTHER
MedImmune LLC
INDUSTRY
Responsible Party
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Locations
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Research Site
Belo Horizonte, , Brazil
Research Site
Campinas, , Brazil
Research Site
Porto Alegre, , Brazil
Research Site
Porto Alegre, , Brazil
Research Site
Brno, , Czechia
Research Site
Hradec Králové, , Czechia
Research Site
Liberec, , Czechia
Research Site
Pardubice, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Ústí nad Labem, , Czechia
Research Site
Budapest, , Hungary
Research Site
Budapest, , Hungary
Research Site
Beersheba, , Israel
Research Site
Haifa, , Israel
Research Site
Jerusalem, , Israel
Research Site
Jerusalem, , Israel
Research Site
Petah Tikva, , Israel
Research Site
Ramat Gan, , Israel
Research Site
Tel Aviv, , Israel
Research Site
Alkmaar, , Netherlands
Research Site
Nijmegen, , Netherlands
Research Site
Nijmegen, , Netherlands
Research Site
Bydgoszcz, , Poland
Research Site
Lodz, , Poland
Research Site
Lodz, , Poland
Research Site
Kazan', , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Banská Bystrica, , Slovakia
Research Site
Nitra, , Slovakia
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Pontevedra, , Spain
Research Site
Dundee, , United Kingdom
Research Site
Leeds, , United Kingdom
Research Site
Stevenage, , United Kingdom
Countries
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References
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Bonaca MP, Morrow DA, Bergmark BA, Berg DD, Lima JAC, Hoffmann U, Kato Y, Lu MT, Kuder J, Murphy SA, Spinar J, Oude Ophuis T, Kiss RG, Lopez-Sendon J, Averkov O, Wheatcroft SB, Kubica J, Carlos Nicolau J, Furtado RHM, Abuhatzira L, Hirshberg B, Omar SA, Vavere AL, Chang YT, George RT, Sabatine MS. Randomized, Placebo-Controlled Phase 2b Study to Evaluate the Safety and Efficacy of Recombinant Human Lecithin Cholesterol Acyltransferase in Acute ST-Segment-Elevation Myocardial Infarction: Results of REAL-TIMI 63B. Circulation. 2022 Sep 20;146(12):907-916. doi: 10.1161/CIRCULATIONAHA.122.059325. Epub 2022 Aug 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D5780C00007
Identifier Type: -
Identifier Source: org_study_id
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