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-IT
• Lead Sponsor: CSL BEHRING GMBH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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
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
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