E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
CORONARY ARTERY DISEASE |
ENFERMEDAD CORONARIA |
|
E.1.1.1 | Medical condition in easily understood language |
CORONARY ARTERY DISEASE |
ENFERMEDAD 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 | 16.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10011082 |
E.1.2 | Term | Coronary artery disorders |
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 compare the degree of inhibition of platelet aggregation (IPA) after administration of prasugrel versus ticagrelor at 1 week on treatment. |
Comparar el grado de inhibición de la agregación plaquetaria (IAP) producido por prasugrel con el producido por ticagrelor a la semana de su administración. |
|
E.2.2 | Secondary objectives of the trial |
To compare the degree of inhibition of platelet aggregation (IPA) at 0 (baseline), and 24 hours after the administration of both treatment groups. To compare the degree of inhibition of platelet reactivity (IRP) throughout the time period in both treatment groups. To evaluate the safety of the treatment administered. |
Comparar el grado de inhibición de la agregación plaquetaria (IAP) basal y a las 24 horas de la administración de prasugrel o ticagrelor. Comparar el grado de inhibición de la reactividad plaquetaria (IRP) en toda la secuencia temporal en ambos grupos de tratamiento. Evaluar la seguridad de los tratamientos administrados |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age ? 75 years. Angiographically documented Coronary Artery Disease. Chronic treatment (? 1 month) with dual antiplatelet therapy: aspirin (100mg/day) and clopidogrel (75mg/day). High platelet reactivity Informed consent appropriately signed. |
|
E.4 | Principal exclusion criteria |
Known allergies to aspirin, clopidogrel, prasugrel, or ticagrelor. Blood dyscrasia or bleeding diathesis. Recent acute coronary syndrome (< 30 days) or hemodinamic instability. Recent antiplatelet therapy (< 14 days), with the exception of aspirin and clopidogrel, including: cilostazol, dipiridamol, glycoprotein IIb/IIIa inhibitors. Concomitant oral anticoagulation. Any active bleeding. History of stroke, ischemic transient attack or intracranial bleeding. Platelet count < 100,000 / ?L. Any active neoplasm. Severe chronic kidney disease (creatinine clearance measured with Cockroft-Gault formula < 30mL/min). Baseline ALT > 2.5 times the upper limit of normality. Participation in another study involving the administration of an investigational product in the past 4 months. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Inhibition of platelet aggregation (IPA) by light transmission aggregometry at one week after administration of study drugs |
Grado de inhibición de la agregación plaquetaria cuantificada mediante agregometría de transmisión de luz a la semana del tratamiento experimental |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
screening, baseline, 24 hours and one week |
|
E.5.2 | Secondary end point(s) |
IAP by light transmission aggregometry at baseline and 24 hours after administration of study medication. Inhibition of platelet reactivity (IRP) throughout the sequence. Incidence of adverse events. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
screening, baseline, 24 hours and one week |
|
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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
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) | Yes |
E.8.2.2 | Placebo | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 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
|
lvls |
ultima visita del ultimo paciente |
|
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 |