CompletedPhase 3

Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome

United States18,226 participantsStarted 2018-03-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Diabetes mellitus on pharmacotherapy OR
✓. 2 or more of the following: age ≥ 65 years, prior history of MI, peripheral arterial disease

What they're measuring

Number of Participants With First Occurrence of Any Component of Composite MACE (CV Death, MI, or Stroke)

Timeframe: From the time of randomization through 90 days

Trial details

NCT IDNCT03473223

SponsorCSL Behring

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-16

Results submitted2024-10-04

View on ClinicalTrials.gov More Acute Coronary Syndrome trials