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Lipid-Lowering Agent

Bempedoic Acid + Ezetimibe for Acute Coronary Syndrome

Phase 4
Waitlist Available
Led By Alan S Go, MD
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women age >18 years
A documented recent ACS event (i.e., defined as up to 14 days post-discharge from an index hospitalization for a non-ST-elevation MI [NSTEMI] or ST-elevation MI [STEMI] necessitating urgent and/or emergent percutaneous coronary intervention [PCI] and/or coronary after bypass graft [CABG])
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-12 weeks
Awards & highlights

Study Summary

This trial is testing a new cholesterol-lowering drug in people who have recently had a heart attack or stroke. The goal is to see if the drug is effective and safe.

Eligible Conditions
  • Cardiovascular Disease
  • Heart Attack
  • Myocardial Infarction

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are older than 18 years old.
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You recently had a heart attack and received urgent heart procedures within the last 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the efficacy of BA/E vs. matching placebo on LDL-C level following a recent ACS event.
Secondary outcome measures
To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.
Other outcome measures
To assess the safety and tolerability of BA/E vs. matching placebo following a recent ACS event.
To explore the clinical effectiveness of BA/E vs. usual care on all-cause and cause-specific morbidity and mortality following a recent ACS event.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: InterventionActive Control1 Intervention
Bempedoic acid 180 mg/ezetimibe 10 mg
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor
534 Previous Clinical Trials
24,110,014 Total Patients Enrolled
Esperion Therapeutics, Inc.Industry Sponsor
25 Previous Clinical Trials
21,418 Total Patients Enrolled
Alan S Go, MDPrincipal InvestigatorKaiser Permanente Northern California Division of Research
1 Previous Clinical Trials
2,000 Total Patients Enrolled

Media Library

Bempedoic Acid / Ezetimibe Oral Tablet (Lipid-Lowering Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05263778 — Phase 4
Cardiovascular Disease Research Study Groups: Placebo, Intervention
Cardiovascular Disease Clinical Trial 2023: Bempedoic Acid / Ezetimibe Oral Tablet Highlights & Side Effects. Trial Name: NCT05263778 — Phase 4
Bempedoic Acid / Ezetimibe Oral Tablet (Lipid-Lowering Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05263778 — Phase 4

Frequently Asked Questions

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

Are there any unfilled positions for participants in this research project?

"As is evidenced on clinicaltrials.gov, this study has completed its recruitment and the trial was initially posted on March 1st 2022 with no updates since then. However, there are currently 604 other medical trials actively searching for patients."

Answered by AI

What risks or potential side effects should one consider when using Intervention?

"This intervention has been approved, so its safety is rated a 3 on the Power team's scale. This corresponds to being in Phase 4 of clinical trials."

Answered by AI
~167 spots leftby Mar 2025