Study to Investigate CSL112 in Subjects with Acute Coronary Syndrome (AEGIS-II)
- Conditions
- Acute coronary syndromeAcute coronary syndrome is a life-threatening condition, which most commonly occurs when an atherosclerotic plaque ruptures or erodes, leading to thrombus formation within a coronary artery.
- Registration Number
- JPRN-jRCT2080224998
- Lead Sponsor
- CSL Behring K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 18200
1. Male or female least 18 years of age
2. Evidence of myocardial necrosis, consistent
with type 1 (spontaneous) MI
3. No suspicion of acute kidney injury
4. Evidence of multivessel coronary artery disease
5. Presence of established cardiovascular risk factor(s):
a. Diabetes mellitus on pharmacotherapy OR
b. 2 or more of the following: age greater or equal to 65 years, prior history of MI, peripheral arterial disease
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>The primary endpoint is time to first occurrence of any component of the composite MACE, defined as CV death, MI, or stroke from the time of randomization through 90 days.<br>The primary endpoint will include all MIs.
- Secondary Outcome Measures
Name Time Method efficacy<br>1. Total number of hospitalizations for coronary, cerebral, or peripheral ischemia from the time of randomization through 90 days.<br>2. Time to first occurrence of CV death, MI, or stroke from the time of randomization through 180 days.<br>3. Time to first occurrence of CV death, MI, or stroke from the time of randomization through 365 days.