E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The use of ticagrelor in ACS is related to a reduction in the number of CECs and/or an increase in the number of EPCs from the baseline values as compared with clopidogrel. |
El uso de ticagrelor en el SCA se relaciona con una reducción en el número de CECs y/o un aumento en el número de EPCs en comparación con el tratamiento con clopidogrel. |
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E.1.1.1 | Medical condition in easily understood language |
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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 |
To evaluate the impact of treatment with ticagrelor or clopidogrel in the number of CECs and EPCs in ACS patients, from baseline values to subacute (?48 hours) or chronic (1 month) levels. |
Analizar la influencia del tratamiento con ticagrelor o clopidogrel en el número de CECs y EPCs en pacientes con SCA, desde niveles basales hasta niveles en fase subaguda (?48 horas) o crónica (1 mes). |
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E.2.2 | Secondary objectives of the trial |
To analyze platelet reactivity at 3 time points (before establishing dual antiplatelet treatment (DAPT), 48 hours after the last episode of angina and after 1 month on DAPT) and its correlation with the number of CECs and EPCs. This parameter is also a control of the primary antiplatelet effect |
Analizar la reactividad plaquetaria en distintos momentos (antes del inicio del doble tratamiento antiagregante, 48 horas tras el último episodio anginoso y al mes de tratamiento) y su correlación con el recuento de CECs y EPCs. Este parámetro sirve, además, de control de la acción primaria de los antiagregantes. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Provision of informed consent prior to any study specific procedures 2.Patients older than 18 years. 3.Males; postmenopausal women or under contraceptive treatment. 4.Clinical diagnosis of ACS + Elevation of myocardial damage diagnostic biomarkers, using the 3rd universal definition of myocardial infarction31 5.Planned early invasive strategy, coronary angiography <72 hours after admission |
1.Declaración de Consentimiento Informado específico firmado. 2.Pacientes mayores de 18 años. 3.Varones; mujeres post-menopaúsicas o bajo tratamiento anticonceptivo. 4.Diagnóstico clínico de SCA + Elevación de biomarcadores diagnósticos de infarto de miocardio según la 3ª definición universal de infarto31 5.Estrategia invasiva precoz planeada, con realización de coronariografía en las primeras 72 horas tras el ingreso |
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E.4 | Principal exclusion criteria |
1.Allergy or contraindication to aspirin, clopidogrel or ticagrelor. 2.Bleeding diathesis or very high risk of bleeding. 3.Participation in another study that has not reached the programmed follow-up. 4.Current treatment with oral anticoagulants, thienopyridines or ticagrelor. 5.Limited life expectancy. 6.Planned elective surgery. 7.Failure for completing the study |
1.Alergia o contraindicación formal al uso de aspirina, clopidogrel o ticagrelor. 2.Diátesis hemorrágica o riesgo muy elevado de hemorragias. 3.Participación en otro estudio que no ha alcanzado el objetivo. 4.Tratamiento actual con anticoagulantes orales, tienopiridinas o ticagrelor. 5.Esperanza de vida limitada. 6.Cirugía electiva planificada. 7.Elevada posibilidad de no poder completar el seguimiento |
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E.5 End points |
E.5.1 | Primary end point(s) |
The clinical variables of each patient included in the study will be recorded in the Case Report Form (CRF) by the investigators or co-investigators from personal interviews or from the medical records. All these variables will be registered in single, local, specific databases |
Las variables propias de cada paciente incluido en el estudio serán obtenidas mediante entrevista del paciente y recogida de datos de la historia clínica del paciente por parte de los investigadores y co-investigadores. El registro de las variables se realizará en una base de datos electrónica local en cada centro |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
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 | No |
E.8.1.3 | Single blind | Yes |
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 | 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
| 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 | 3 |
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
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LVLS |
Última visita del último paciente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |