E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Coronary artery disease |
Enfermedad arterial coronaria |
|
E.1.1.1 | Medical condition in easily understood language |
Coronary artery disease |
Enfermedad arterial coronaria |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011078 |
E.1.2 | Term | Coronary artery disease |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
|
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 |
To evaluate the effect of ivabradine treatment for 18 months on atherosclerotic disease progression as assessed using coronary Intravascular Ultrasound (IVUS) |
Evaluar el efecto del tratamiento con ivabradina durante 18 meses sobre la progresión de la enfermedad ateroesclerótica evaluada mediante Ultrasonido Intravascular (IVUS) |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate the effect of ivabradine on coronary plaque composition and other plaque characteristics using Virtual Histology IVUS (VH-IVUS) and Optical Coherence Tomography (OCT), - To assess the effect of ivabradine on wall shear stress. - To evaluate the effect of ivabradine on atherosclerosis progression using quantitative coronary angiography, - To assess the effect of ivabradine on several clinical endpoints as well as safety. |
- Evaluar el efecto de la ivabradina sobre la composición de la placa coronaria y otras características de la placa mediante Ultrasonido Intravascular con Histología Virtual (VH-IVUS) y Tomografía de Coherencia Optica (OCT), - Evaluar el efecto de la ivabradina en el estrés de cizallamiento de la pared arterial (WSS). - Evaluar el efecto de la ivabradina sobre la progresión de la ateroesclerosis mediante Angiografía Coronaria Cuantitativa (ACC), - Evaluar el efecto de la ivabradina en ciertas variables clínicas así como la seguridad. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female of any ethnic origin aged 18 years or older at the date of selection, - Patients with a clinically indicated coronary angiography, - Patients in sinus rhythm and heart rate equal or higher than 70 bpm, - Treatment with optimal dose of lipid lowering therapies including statins (unless not-tolerated) to ensure that LDL dosage is within recommended range following local practice, as well as recommended treatment for CAD. |
- Hombres o mujeres, de cualquier etnia, con edad igual o superior a 18 años en el momento de la selección, - Pacientes con indicación clínica de angiografía coronaria, - Pacientes con ritmo sinusal y frecuencia cardíaca (FC) mayor o igual a 70 lpm, - Tratamiento con terapia hipolipemiante en dosis óptimas, incluidas estatinas (a no ser que no sean toleradas) para asegurar que los niveles de LDL están dentro del rango local recomendado, así como tratamiento recomendado para la EAC. |
|
E.4 | Principal exclusion criteria |
- Primary percutaneous coronary intervention for acute myocardial infarction with ST elevation at selection visit; - Previous coronary artery bypass graft (CABG) surgery or probable need for CABG in the next 18 months; - Valvular disease likely to require surgery during the treatment period of the study; - Patients with transplanted heart; - Implanted pacemaker, implantable cardioverter defibrillator, cardiac resynchronisation therapy; - Known hypersensitivity to ivabradine; - Known hereditary problems of galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption; - Myocardial infarction in the target coronary artery for IVUS. |
- ICP primaria por infarto agudo de miocardio con elevación de ST en la visita de selección; - Cirugía previa de bypass coronario o probable necesidad de la misma en los 18 meses siguientes; - Valvulopatía con probable necesidad de cirugía durante el periodo de tratamiento del estudio; - Trasplante de corazón; - Marcapasos implantado, desfibrilador automático implantable, terapia de resincronización cardíaca; - Hipersensibilidad conocida a la ivabradina; - Problemas hereditarios conocidos de intolerancia a la galactosa, deficiencia de la lactasa Lapp o malabsorción de glucosa y galactosa; - Infarto de miocardio en la arteria coronaria diana para el IVUS |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Nominal change in coronary Percent Atheroma Volume (PAV) |
Volumen porcentual basal del ateroma coronario (VPA) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline to the end of the study |
Desde basal hasta el final del estudio |
|
E.5.2 | Secondary end point(s) |
- Various imaging efficacy endpoints assessed by coronary IVUS, coronary VH-IVUS in a sub-population, coronary QCA, coronary OCT in a sub-population and WSS - Clinical efficacy endpoints - Safety endpoints |
- Variables de eficacia (estudios de imagen) mediante coronarias IVUS, coronarias VH-IVUS en una subpoblación, Angiografía Coronaria Cuantitativa (ACC), OCT coronaria en una subpoblación y WSS - Variables de eficacia clínica - Variables de seguridad |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
From baseline to study end |
Desde basal hasta el final del estudio |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 70 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Belgium |
Canada |
Czech Republic |
Finland |
France |
Germany |
Italy |
Korea, Republic of |
Malaysia |
Netherlands |
Poland |
Russian Federation |
Singapore |
Slovakia |
Spain |
Switzerland |
Taiwan |
United Kingdom |
|
E.8.7 | Trial has a data monitoring committee | No |
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
|
Last Visit Last Participant as stated in the protocol |
Última Visita del Último Paciente como indica el protocolo |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |