A Study to Evaluate the Safety and Efficacy of MEDI6012 in Acute ST Elevation Myocardial Infarction (REAL-TIMI 63B)
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|ClinicalTrials.gov Identifier: NCT03578809|
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : October 25, 2018
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 subjects presenting with acute STEMI (ST segment elevation myocardial infarction).
The study will enrol subjects presenting with acute STEMI who are planned for primary percutaneous coronary intervention (pPCI). For all subjects, an end of study CMR will be performed at 10-12 weeks (70-84 days following Dose 1). A subset of subjects 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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||414 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||In this study, the subject 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.|
|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|
|Estimated Primary Completion Date :||January 12, 2021|
|Estimated Study Completion Date :||January 12, 2021|
Experimental: Cohort A
Experimental: Cohort B
|Placebo Comparator: Placebo||
- Infarct size [ Time Frame: 10-12 weeks ]Infarct size as a percentage of LV mass measured on delayed-enhanced CMR imaging 10-12 weeks post-MI compared to placebo.
- Ejection Fraction [ Time Frame: 10-12 weeks ]EF measured by cine MRI at 10-12 weeks post-MI compared to placebo.
- Non Calcified Plaque Volume [ Time Frame: 10-12 weeks ]Change in NCPV in the coronary arteries from index CTA (Computed Tomography) to 10-12 weeks post-MI compared with placebo.
- Myocardial Mass [ Time Frame: 10-12 weeks ]Myocardial mass
- Adverse Events [ Time Frame: 0-12 weeks ]Incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs).
- LCAT Mass [ Time Frame: 0-12 weeks ]LCAT (lecithin-cholesterol acyltransferase) mass
- Left Ventricular Volumes [ Time Frame: 10-12 Weeks ]LV (left ventricular) volumes at end-systole
- Incidence Rate of Immunogenicity [ Time Frame: 0-12 weeks ]Immunogenicity is measured by anti-drug antibodies (ADAs).
- Left Ventricular Volumes [ Time Frame: 10-12 weeks ]LV (left ventricular) volumes at end-diastole.
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
|Contact: AstraZeneca Clinical Study Information Centeremail@example.com|
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