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Apolipoprotein

Apolipoprotein A-I [human] (apoA-I) for Acute Coronary Syndrome (AEGIS-II Trial)

Phase 3
Waitlist Available
Research Sponsored by CSL Behring
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No suspicion of acute kidney injury
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 365 days
Awards & highlights

AEGIS-II Trial Summary

This trial will test if CSL112 can reduce the risk of major adverse cardiovascular events in people with acute coronary syndrome.

Eligible Conditions
  • Acute Coronary Syndrome

AEGIS-II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You do not have any signs of sudden kidney damage.

AEGIS-II Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 365 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 365 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to first occurrence of any component of composite MACE (CV death, MI, or stroke )
Secondary outcome measures
Key : Time to first occurrence of CV death, MI, or stroke
Key : Total number of hospitalizations for coronary, cerebral, or peripheral ischemia
Number 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)
+11 more

AEGIS-II Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CSL112Experimental Treatment1 Intervention
Apolipoprotein A-I [human]
Group II: PlaceboPlacebo Group1 Intervention
25% albumin solution diluted to 4.4%
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apolipoprotein A-I [human] (apoA-I)
2018
Completed Phase 3
~18200

Find a Location

Who is running the clinical trial?

CSL BehringLead Sponsor
194 Previous Clinical Trials
1,193,022 Total Patients Enrolled
Danielle Duffy, MDStudy DirectorCSL Behring - Sr Global Clinical Program Dir - CV & Metabolism
2 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

CSL112 (Apolipoprotein) Clinical Trial Eligibility Overview. Trial Name: NCT03473223 — Phase 3
Acute Coronary Syndrome Research Study Groups: Placebo, CSL112
Acute Coronary Syndrome Clinical Trial 2023: CSL112 Highlights & Side Effects. Trial Name: NCT03473223 — Phase 3
CSL112 (Apolipoprotein) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03473223 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are signed up to take part in this research project?

"Per the information available on clinicaltrials.gov, this trial is currently seeking patients for enrollment. The study was first posted on March 21st, 2018 and has since been updated on October 10th, 2022. A total of 18200 individuals are needed at 100 different sites."

Answered by AI

At how many different hospitals or research facilities can people participate in this trial?

"This experiment is looking for participants at 8400572 - AtlantiCare Regional Medical Center, 8401178 - Jersey Shore University Medical Center Meridian Health, and 8400489 - Duke University Hospital as well as 100 other facilities."

Answered by AI

Are patients currently being signed up for this clinical trial?

"Yes, the trial is still looking for participants. The initial posting was on March 21st, 2018 and the clinicaltrials.gov page was updated as recently as October 10th, 2022."

Answered by AI

Does apoA-I have the potential to harm people?

"Apolipoprotein A-I [human] (apoA-I) has received a safety score of 3. This is based on the fact that it is a Phase 3 trial, meaning there is some data supporting efficacy and multiple rounds of data supporting safety."

Answered by AI
~2600 spots leftby Mar 2025