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Lipid-Lowering Agent
Bempedoic Acid + Ezetimibe for Acute Coronary Syndrome
Phase 4
Waitlist Available
Led By Andrew P Ambrosy, MD
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-12 weeks
Awards & highlights
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
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To evaluate the efficacy of BA/E vs. matching placebo on LDL-C level following a recent ACS event.
Secondary study objectives
To determine the efficacy of BA/E vs. matching placebo on the lipid profile following a recent ACS event.
Other study objectives
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
551 Previous Clinical Trials
27,690,460 Total Patients Enrolled
Esperion Therapeutics, Inc.Industry Sponsor
25 Previous Clinical Trials
21,418 Total Patients Enrolled
Andrew P Ambrosy, MDPrincipal InvestigatorKaiser Permanente Northern California Division of Research
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: Intervention
- Group 2: Placebo
Awards:
This trial has 4 awards, including:- 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.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
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.
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