E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute coronary syndrome with poor LDL-cholesterol control |
Síndrome coronario agudo con mal control de colesterol LDL |
|
E.1.1.1 | Medical condition in easily understood language |
Acute coronary syndrome |
Síndrome coronario agudo |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Percentage of patients who achieve LDL-cholesterol values < 55 mg/dL at 8 weeks |
Porcentaje de pacientes que consiguen cifras de colesterol LDL < 55 mg/dL a las 8 semanas |
|
E.2.2 | Secondary objectives of the trial |
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. |
1. Cambio absoluto del cLDL basal a las 8 semanas. 2. Cambio porcentual del colesterol no-HDL basal a 8 semanas. 3. Cambio porcentual de cHDL y triglicéridos basales a 8 semanas. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
1. cLDL ≥70 mg/dl persistente a pesar de régimen basal estable (≥4 semanas) de estatinas de alta potencia hipolipemiante, O 2. cLDL ≥100 mg/dl en pacientes que no toleran estatinas de alta potencia hipolipemiante o que no están tratados con estatinas de alta potencia, incluyendo pacientes no tratados con estatinas. |
|
E.4 | Principal 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. |
1) Pacientes con menos de 18 años, embarazadas o en fase de lactancia. 2) Pacientes con contraindicación absoluta o relativa para ácido bempedoico o ezetimibe. 3) Pacientes con Triglicéridos ≥400 mg/dL. 4) Pacientes a tratamiento con fibratos y/o inhibidor de PCSK9. 5) Pacientes con esperanza de vida limitada (< 1 año) a juicio del médico responsable. 6) Pacientes en otro ensayo clínico. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of patients who achieve LDL-cholesterol values < 55 mg/dL at 8 weeks |
Porcentaje de pacientes que consiguen cifras de colesterol LDL < 55 mg/dL a las 8 semanas |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | 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. |
1. Cambio absoluto del cLDL basal a las 8 semanas. 2. Cambio porcentual del colesterol no-HDL basal a 8 semanas. 3. Cambio porcentual de cHDL y triglicéridos basales a 8 semanas. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
PRAGMATICO, INDEPENDIENTE |
PRAGMATIC, INDEPENDENT |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
PRÁCTICA CLÍNICA DIARIA |
CLINCIAL DAILY PRACTICE |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |