CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 593 enrolled
Drug / intervention
MEDI6012 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03578809
NCT03578809Phase 2Completed

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

MedImmune LLC·interventional·Posted Jul 6, 2018·Updated Feb 9, 2022

In Brief

A Phase 2 clinical trial evaluating MEDI6012 and Placebo for ST Elevation Myocardial Infarction. Completed, enrolled 593 participants across 37 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, Czechia, Hungary, Israel, Netherlands, Poland, Russia, Slovakia, Spain, United Kingdom

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 6, 2018
Enrollment StartJun 5, 2018
Primary CompletionJan 18, 2021
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 8.0 years ago

Interventions

MEDI6012biological

MEDI6012

Placeboother

Placebo