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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 belowSelect...
You are older than 18 years old.
Select...
You recently had a heart attack and received urgent heart procedures within the last 14 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-12 weeks
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with gout or have high levels of uric acid in your blood.You are living in an institution or receiving comfort care.You are older than 18 years old.You have had issues with your tendons tearing or becoming injured in the past.You are currently taking or planning to take certain medications like simvastatin, pravastatin, cyclosporine, fibrates, or bile acid sequestrants that could interact with the study drug.You have a serious illness that could limit your life, like advanced heart, liver, or kidney disease, metastatic cancer, or receiving strong chemotherapy.You recently had a heart attack and received urgent heart procedures within the last 14 days.You have received blood transfusions or blood products within the 3 months before enrolling in the study.You have had a bad reaction to BA/E in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Intervention
Awards:
This trial has 4 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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