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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHeart Care Foundation

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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),

Trial design

Treatments tested in this trial

  • Triple oral lipid lowering treatment

Treatment groups

600 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Heart Care Foundation

Lead sponsor

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Collaborator