Status:
COMPLETED
Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome
Lead Sponsor:
CSL Behring
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2023
Estimated Enrollment :
18226 Patients enrolled
Trial Details
Trial ID
NCT03473223
Start Date
March 21 2018
End Date
November 17 2023
Last Update
January 14 2025
Active Locations (903)
Enter a location and click search to find clinical trials sorted by distance.
1
8400896 - Advanced Cardiovascular LLC
Alexander City, Alabama, United States, 35010
2
8400350 - Cardiology, PC
Birmingham, Alabama, United States, 35211
3
8400337 - Heart Center Research, LLC
Huntsville, Alabama, United States, 35801
4
8400713 - University of South Alabama College of Medicine
Mobile, Alabama, United States, 36617