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

ConditionsAcute Coronary SyndromesSecondary PreventionLipids
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Triple oral lipid lowering treatment

    Drug

    Triple oral lipid lowering treatment including high intensity statin, ezetimibe and bembedoic acid

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: High intensity statin plus ezetimibe plus bempedoic acidExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean percent change in LDL-c levels

the difference in the mean percent change in LDL-c levels from baseline at 8 weeks between triple combo therapy and usual care.

Time frame
8 weeks

Secondary outcomes

1

Percentage of patients with LDL-c level <70 mg/dL

Difference in percentage of patients with LDL-c level \<70 mg/dL at 8 weeks

Time frame
8 weeks
2

Percentage of patients with LDL-c level <55 mg/dL

Difference in percentage of patients with LDL-c level \<55 mg/dL at 8 weeks

Time frame
8 weeks
3

Percentage of patients with LDL-c level <40 mg/dL in those with a recurrent ACS event in the previous 48 months

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

Time frame
8 weeks
4

Change in high-sensitivity CRP (hs-CRP)

Change in high-sensitivity CRP (hs-CRP) at 8 weeks

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Heart Care Foundation

Lead sponsor

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: