Clinical trial NCT03578809: A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction
Official title: A Randomized, Placebo-controlled Phase 2b Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: ST Elevation Myocardial Infarction
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
Collaborators: name: The TIMI Study Group
First posted: 2018-07-06
Enrollment: 593
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Global Infarct Size
timeFrame: 70 to 84 days post Day 1 dose
Secondary outcomes:
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: 70 to 84 days post Day 1 dose
measure: Change in Non-calcified Plaque Volume (NCPV) in the Coronary Arteries in Cohort B
timeFrame: Day 1 dose (48 to 72 hours post Dose 1) through 70 to 84 days post Day 1 dose
measure: Left Ventricular Mass by Late Gadolinium Enhancement (LGE)
timeFrame: 70 to 84 days post Day 1 dose
measure: Left Ventricular Mass by Cine Magnetic Resonance Imaging (MRI)
timeFrame: 70 to 84 days post Day 1 dose
measure: Left Ventricular End-diastolic and End-systolic Volume
timeFrame: 70 to 84 days post Day 1 dose
measure: Left Ventricular End-diastolic and End-systolic Volume Index
timeFrame: 70 to 84 days post Day 1 dose
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: Day 1 through Day 195 post Day 1 dose
measure: Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass)
timeFrame: Pre- and post-dose on Days 1, 3, 17, and 31
measure: Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012
timeFrame: Predose on Day 1, Day 17, Day 31, 70 to 84 days, and on Day 195 post Day 1 dose
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Research Site
city: Campinas
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Hradec Kralove
country: Czechia
facility: Research Site
city: Liberec
country: Czechia
facility: Research Site
city: Pardubice
country: Czechia
facility: Research Site
city: Praha 10
country: Czechia
facility: Research Site
city: Praha 2
country: Czechia
facility: Research Site
city: Usti nad Labem
country: Czechia
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Beer Sheva
country: Israel
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Petah Tikva
country: Israel
facility: Research Site
city: Ramat Gan
country: Israel
facility: Research Site
city: Tel Aviv
country: Israel
facility: Research Site
city: Alkmaar
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Banska Bystrica
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Pontevedra
country: Spain
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Stevenage
country: United Kingdom
facility: Research Site
Study officials:
References:
citation: 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.