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

ST Elevation Myocardial Infarction Clinical Trial

— REAL-TIMI 63B  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03578809
• Other study ID #: D5780C00007
• Status: Completed
• Phase: Phase 2
• Start date: June 5, 2018
• Est. completion date: January 18, 2021

Study information

• Verified date: January 2022
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 593
• Est. completion date: January 18, 2021
• Est. primary completion date: January 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Biological:
• MEDI6012
MEDI6012

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Brazil	Research Site	Belo Horizonte
Brazil	Research Site	Campinas
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Czechia	Research Site	Brno
Czechia	Research Site	Hradec Kralove
Czechia	Research Site	Liberec
Czechia	Research Site	Pardubice
Czechia	Research Site	Praha 10
Czechia	Research Site	Praha 2
Czechia	Research Site	Usti nad Labem
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Israel	Research Site	Beer Sheva
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
Netherlands	Research Site	Alkmaar
Netherlands	Research Site	Nijmegen
Netherlands	Research Site	Nijmegen
Poland	Research Site	Bydgoszcz
Poland	Research Site	Lodz
Poland	Research Site	Lodz
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint Petersburg
Slovakia	Research Site	Banska Bystrica
Slovakia	Research Site	Nitra
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Pontevedra
United Kingdom	Research Site	Dundee
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	Stevenage

Sponsors (2)

Lead Sponsor	Collaborator
MedImmune LLC	Thrombolysis in Myocardial Infarction (TIMI) Study Group

Countries where clinical trial is conducted

Brazil,  Czechia,  Hungary,  Israel,  Netherlands,  Poland,  Russian Federation,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Infarct Size	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.	70 to 84 days post Day 1 dose
Secondary	Left Ventricular Ejection Fraction (LVEF)	The LVEF measured by cine magnetic resonance imaging (MRI) at 10-12 weeks post-MI is reported.	70 to 84 days post Day 1 dose
Secondary	Change in Non-calcified Plaque Volume (NCPV) in the Coronary Arteries in Cohort B	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.	Day 1 dose (48 to 72 hours post Dose 1) through 70 to 84 days post Day 1 dose
Secondary	Left Ventricular Mass by Late Gadolinium Enhancement (LGE)	The left ventricular mass by LGE is reported.	70 to 84 days post Day 1 dose
Secondary	Left Ventricular Mass by Cine Magnetic Resonance Imaging (MRI)	The left ventricular mass by cine MRI is reported.	70 to 84 days post Day 1 dose
Secondary	Left Ventricular End-diastolic and End-systolic Volume	Left ventricular end-diastolic and end-systolic volume is reported.	70 to 84 days post Day 1 dose
Secondary	Left Ventricular End-diastolic and End-systolic Volume Index	Left ventricular end-diastolic and end-systolic volume index is reported.	70 to 84 days post Day 1 dose
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)	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.	Day 1 through Day 195 post Day 1 dose
Secondary	Serum Concentration of MEDI6012 (Lecithin-cholesterol Acyltransferaes [LCAT] Mass)	Serum concentration of MEDI6012 is reported.	Pre- and post-dose on Days 1, 3, 17, and 31
Secondary	Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI6012	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.	Predose on Day 1, Day 17, Day 31, 70 to 84 days, and on Day 195 post Day 1 dose

External Links

•   D5780C00007 CSP Redacted
•   D5780C00007 CSR Synopsis Redacted
•   D5780C00007 SAP Redacted