Heart Attacks
main-banner
Heart Attacks
CSL112_3001 Enrolling

Heart Attack Research Study (12 Months)


Treatment: Injection Age: 18 Years

Adults aged 18 and older who have experienced a recent heart attack (myocardial infarction), may qualify to participate in this study.  Evidence of coronary artery disease (blocking of the heart’s arteries) must be present.  Individuals must also have one of the following established risk factors: aged 65 years or older, prior history of myocardial infarction, on treatment for diabetes, OR have peripheral arterial disease (blocking of the arteries to other areas and organs of the body).

Eligible participants will receive investigational medication via IV infusion, meaning directly into a vein. Individuals will receive either active study drug or placebo (albumin).  Study medication and study-related care will be provided at no cost.  Reimbursement for study-related expenses may be provided.

Study participation will last approximately 12 months and include about 11 visits to the study centre (2 of these visits may occur by phone).


The following information is from ClinicalTrials.gov

Last Update Posted: November 27, 2022

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

ClinicalTrials.gov ID

NCT03473223

Sponsor

CSL Behring

Study Description

  • Brief 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.

  • Condition or Disease:

    Acute Coronary Syndrome

  • Intervention/Treatment:

    Biological: Apolipoprotein A-I [human] (apoA-I)
    Other: Placebo
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    18 Years and older (Adult)

  • Sexes Eligible for Study:

    All

Inclusion Criteria:

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):

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

Exclusion Criteria:

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


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.


Participating Locations

COUNTRY
country-icon
Canada

Participating Experts

Dr. Michael Hartleib

Cardiologist

You May Also Be Interested In

Similar Trials

No Similar Trials Found
about-icon

Learn More About

Heart Attacks

Learn More
2022 all rights reserved probity medical research inc
find a trial
filter trials