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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.

Primary Objective

The primary objective of this study is to evaluate the efficacy of CSL112 on reducing the risk of MACE (CV death, MI, or stroke) from the time of randomization through 90 days in subjects with ACS (diagnosed with STEMI or NSTEMI)

Study category: Heart and Blood Conditions

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Details
Age

Adult

Phase

II/III - A combination of phases: (2) Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. and (3) Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Type of Study

Treatment

Locations

Harmony Campus
Medical Center of the Rockies

Principal Investigator
Philip Dattilo

Philip Dattilo

Study ID

Protocol Number: 18-6081

More information available at ClinicalTrials.gov: NCT03473223

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