Study to Investigate CSL112 in Subjects with Acute Coronary Syndrome

Phase 1

• Conditions: Acute Coronary Syndrome; MedDRA version: 20.0Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-000996-98-BG
• Lead Sponsor: CSL Behring LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-20
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 17400

Inclusion Criteria

1. Male or female least 18 years of age
2. Evidence of myocardial necrosis, consistent with type (spontaneous) MI
3. No suspicion of acute kidney injury
4. Evidence of multivessel coronary artery disease and at least 1 of the following established risk factors:age = 65 years, prior history of MI, diabetes mellitus, or peripheral artery disease
5. Presence of established cardiovascular risk factor(s):
a. Diabetes mellitus on pharmacotherapy OR
b. 2 or more of the following: age = 65 years, prior history of MI, peripheral arterial disease

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6960
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10440

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of CSL112 in reducing the risk of MACE [Major adverse cardiovascular event(s)][ (CV (cardiovascular)death, MI (Myocardial Infarction), or stroke)] in subjects with ACS (Acute Coronary Syndrome),[diagnosed with STEMI (ST-segment elevation myocardial infarction) or NSTEMI(Non-ST-segment elevation myocardial infarction)].<br>;Secondary Objective: 1. To evaluate the efficacy of CSL112 on reducing the total number of hospitalizations for coronary, cerebral, or peripheral ischemia.<br>2. To evaluate the efficacy of CSL112 on reducing the risk of MACE (CV death, MI, or stroke) in ACS (diagnosed with STEMI or NSTEMI) through 180 and 365 days<br>;Primary end point(s): Time to first occurrence of any component of composite MACE (CV death, MI, or stroke ) ;Timepoint(s) of evaluation of this end point: Through 90 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Total number of hospitalizations for coronary, cerebral, or peripheral ischemia<br>2) and 3) Time to first occurrence of CV death, MI, or stroke<br>4) Time to occurrence of CV death<br>5) Time to first occurrence of MI<br>6) Time to first occurrence of stroke<br>7) Time to first occurrence of CV death, type 1 MI, or stroke<br>8) Time to occurrence of all-cause death<br>9) Number and percent of subjects with adverse events<br>10) Number and percent of subjects with treatment-related adverse events<br>11) Number and percent of subjects with serious adverse events<br>12) Number and percent of subjects with a shift in clinical laboratory assessments from baseline to worst post-treatment value according to normal range criteria (normal, high, or low);Timepoint(s) of evaluation of this end point: 1), 4), 5), 6), 9): Through 90 days<br>2): Through 180 days<br>3), 8), 10), 11): Through 365 days<br>7): Through 90, 180, and 365 days<br>12): Baseline and 29 days