This study is in progress, not accepting new patients

Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome

a study on Acute Coronary Syndrome Unstable Angina

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events [MACE - cardiovascular (CV) death, myocardial infarction (MI), and stroke] in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed.

Official Title

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects With Acute Coronary Syndrome

Keywords

Acute Coronary Syndrome, Syndrome, Apolipoprotein A-I [human] (apoA-I)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Male or female least 18 years of age
  • Evidence of myocardial necrosis, consistent with type I (spontaneous) MI
  • No suspicion of acute kidney injury
  • Evidence of multivessel coronary artery disease
  • Presence of established cardiovascular risk factor(s):
    1. Diabetes mellitus on pharmacotherapy OR
    2. 2 or more of the following: age ≥ 65 years, prior history of MI, peripheral arterial disease

You CAN'T join if...

  • Ongoing hemodynamic instability
  • Evidence of hepatobiliary disease
  • Evidence of severe chronic kidney disease
  • Plan to undergo scheduled coronary artery bypass graft surgery as treatment for the index MI
  • Known history of allergies, hypersensitivity, or deficiencies to soy bean, peanut or albumin

Locations

  • 8400694 - University of California San Diego Medical Center
    San Diego California 92103 United States
  • 8400719 - V.A. San Diego Health Care System
    San Diego California 92161 United States
  • 8400703 - San Diego Cardiac Center
    San Diego California 92123 United States
  • 8401166 - Sharp Grossmont Hospital
    La Mesa California 91942 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CSL Behring
ID
NCT03473223
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 18200 study participants
Last Updated