BempeDoic acid in Acute Coronary Syndrome

Efficacy and Security of BempeDoic acid in Acute Coronary Syndrome - ES-BempeDACS

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-006550-31-ES

Enrollment

206

Registered

2022-01-10

Start date

2022-04-05

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute coronary syndrome with poor LDL-cholesterol control

Interventions

Trade Name: NUSTENDI Product Name: Bempedoic Acid / Ezetimibe Product Code: SUB183128 Pharmaceutical Form: Film-coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Persistent LDL-C =70 mg/dl despite stable baseline regimen (=4 weeks) of high-potency statins, OR 2. LDL-C =100 mg/dl in patients who do not tolerate high-potency statins or who are not treated with high-potency statins, including statin-naïve patients. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 103 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 103

Exclusion criteria

Exclusion criteria: 1) Patients under 18 years of age, pregnant or breastfeeding. 2) Patients with absolute or relative contraindication to bempedoic acid or ezetimibe. 3) Patients with Triglycerides =400 mg / dL. 4) Patients treated with fibrates and/or PCSK9 inhibitor. 5) Patients with limited life expectancy (<1 year) at the judgment of the responsible physician. 6) Patients in another clinical trial.

Design outcomes

Primary

Measure	Time frame
Main Objective: Percentage of patients who achieve LDL-cholesterol values < 55 mg/dL at 8 weeks;Secondary Objective: 1. Absolute change in baseline LDL-C at 8 weeks. 2. Percentage change in baseline non-HDL cholesterol at 8 weeks. 3. Percentage change in HDL-C and basal triglycerides at 8 weeks.;Primary end point(s): Percentage of patients who achieve LDL-cholesterol values < 55 mg/dL at 8 weeks;Timepoint(s) of evaluation of this end point: 8 weeks	—

Measure

Time frame

Main Objective: Percentage of patients who achieve LDL-cholesterol values < 55 mg/dL at 8 weeks;Secondary Objective: 1. Absolute change in baseline LDL-C at 8 weeks. 2. Percentage change in baseline non-HDL cholesterol at 8 weeks. 3. Percentage change in HDL-C and basal triglycerides at 8 weeks.;Primary end point(s): Percentage of patients who achieve LDL-cholesterol values < 55 mg/dL at 8 weeks;Timepoint(s) of evaluation of this end point: 8 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Absolute change in baseline LDL-C at 8 weeks. 2. Percentage change in baseline non-HDL cholesterol at 8 weeks. 3. Percentage change in HDL-C and basal triglycerides at 8 weeks.;Timepoint(s) of evaluation of this end point: 8 weeks	—

Countries

Spain

Contacts

Public ContactALBERT ARIZA-SOLE

SPANISH SOCIETY OF CARDIOLOGY

aariza@bellvitgehospital.cat0034650027523

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 6, 2026