triPle Oral thERapy With Bempedoic Acid vs uSual Care in Early Lipid Management of Patients With acUte coronAry synDromE (PERSUADE)

February 26, 2026 updated by: Heart Care Foundation

triPle Oral thERapy With Bempedoic Acid vs uSual Care in Early Lipid Management of Patients With acUte coronAry synDromE (PERSUADE) Trial

Early and intensive LDL-cholesterol (LDL-c) reduction is associated with improved short-term and long-term outcomes. Bempedoic acid is an oral ATP citrate lyase inhibitor that lowers LDL-c upstream of HMG-CoA reductase. When added to maximally tolerated statins, it has demonstrated significant LDL-c reduction and cardiovascular benefit, particularly in statin-intolerant or high-risk patients. However, evidence on early initiation of bempedoic acid during the index ACS hospitalization is currently lacking. The investigators therefore would like to see whether early (pre-discharge) initiation of an oral triple lipid-lowering therapy including bempedoic acid, high-intensity statin (HIS), and ezetimibe is superior to usual care in reducing LDL-c levels at 8 weeks after randomization in patients hospitalized for ACS.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Despite major improvements in the acute management of Acute Coronary Syndromes (ACS), recurrent cardiovascular events remain frequent after hospital discharge. Real-world registries consistently show suboptimal implementation of guideline-recommended lipid-lowering strategies, with more than 60% of patients failing to achieve recommended LDL-cholesterol (LDL-c) targets after ACS. Early and intensive LDL-c reduction is associated with improved short-term and long-term outcomes. While injectable lipid-lowering therapies such as PCSK9 inhibitors have demonstrated rapid LDL-c reduction when initiated early after ACS, their high cost and parenteral administration limit widespread adoption. Bempedoic acid is an oral ATP citrate lyase inhibitor that lowers LDL-c upstream of HMG-CoA reductase. When added to maximally tolerated statins, it has demonstrated significant LDL-c reduction and cardiovascular benefit, particularly in statin-intolerant or high-risk patients. However, evidence on early initiation of bempedoic acid during the index ACS hospitalization is currently lacking.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • Male and females at birth
  • Admitted for ACS caused by an atherothrombotic coronary event;
  • Calculated LDL-c: 70-140 mg/dL within 24 hours from admission for the ACS index event
  • Lipid lowering therapy on admission consisting of a low/moderate intensity statin or a high intensity statin (HIS); or no lipid lowering therapy (naïve patients)
  • Lipid-lowering therapy at discharge (at the time of randomization) consisting of HIS or HIS + ezetimibe
  • Scheduled home discharge
  • Written informed consent provided; patients who are unable to give informed consent for any reason will be excluded from the study.

Exclusion Criteria:

  • Patients already treated with HIS+Ezetimibe on admission for the ACS event,
  • Patients currently, previously or planned to be treated with PCSK9i or inclisiran,
  • Patients treated currently or in the last 3 months with bempedoic acid or in whom this treatment is planned in the following 8 weeks,
  • Known allergy, sensitivity or intolerance to bempedoic acid and/or study drugs' formulation ingredients (e.g. lactose intolerance),
  • Patients with history of documented intolerance to statins, ezetimibe or bempedoic acid
  • Patients with known Familial Hypercholesterolemia (FH; heterozygous or homozygous),
  • Patients with plasma triglycerides concentration exceeding 400 mg/dL (4.52 mmol/L),
  • Patients with dysbetalipoproteinemia (type III hyperlipoproteinemia),
  • Unstable clinical status (hemodynamic or electrical instability),
  • Severe renal dysfunction (eGFR <30 ml/min/1.73m2 using the CKD-EPI formula),
  • Active liver disease or hepatic dysfunction (AST or ALT levels > 3xUNL),
  • Current enrolment in another investigational device or drug study,
  • Current pregnancy, lactation or women of childbearing potential, unless using highly effective contraception,
  • Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual Care
Experimental: High intensity statin plus ezetimibe plus bempedoic acid
patients will receive a triple oral lipid lowering therapy including a high intensity statin, ezetimibe and bempedoic acid
Drug: Triple oral lipid lowering treatment
Triple oral lipid lowering treatment including high intensity statin, ezetimibe and bembedoic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean percent change in LDL-c levels
Time Frame: 8 weeks
the difference in the mean percent change in LDL-c levels from baseline at 8 weeks between triple combo therapy and usual care.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with LDL-c level <70 mg/dL
Time Frame: 8 weeks
Difference in percentage of patients with LDL-c level <70 mg/dL at 8 weeks
8 weeks
Percentage of patients with LDL-c level <55 mg/dL
Time Frame: 8 weeks
Difference in percentage of patients with LDL-c level <55 mg/dL at 8 weeks
8 weeks
Percentage of patients with LDL-c level <40 mg/dL in those with a recurrent ACS event in the previous 48 months
Time Frame: 8 weeks
Difference in percentage of patients with LDL-c level <40 mg/dL at 8 weeks in those with a recurrent ACS event in the previous 48 months
8 weeks
Change in high-sensitivity CRP (hs-CRP)
Time Frame: 8 weeks
Change in high-sensitivity CRP (hs-CRP) at 8 weeks
8 weeks
Persistence of active treatment and discontinuation rate
Time Frame: 8 weeks
Rate of persistence of active treatment and discontinuation rate of allocated treatment
8 weeks
Rate of adverse events
Time Frame: 8 weeks
Safety of the investigational study drug by adverse event recording
8 weeks
Rate of adverse events
Time Frame: 3 months
Safety of the investigational study drug by adverse event recording
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Care Foundation

Collaborators

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Investigators

  • Study Chair: Furio Colivicchi, MD, San Filippo neri Hospital - Rome
  • Study Chair: Aldo P Maggioni, MD, Fondazione per il Tuo cuore
  • Study Chair: Pietro Scicchitano, MD, Ospedale Miulli - Bari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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