Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome (AEGIS-II)
Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome (AEGIS-II)
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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 17400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date: March 21, 2018
Estimated Primary Completion Date: July 2022
Estimated Study Completion Date: April 2023
Arm:
- Experimental: CSL112
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 17400 |
| Actual Study start date | 21 March 2018 |
| Estimated Study Completion Date | 01 April 2023 |