NCT07440381

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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Heart Care Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Acute Coronary Syndromes
• Secondary Prevention
• Lipids

Interventions

Type	Name	Description
DRUG	Triple oral lipid lowering treatment	Triple oral lipid lowering treatment including high intensity statin, ezetimibe and bembedoic acid

Timeline

• Start date: 2026-09-01
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

35 sites across 1 country: Italy