E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute Coronary Syndrome (ACS) |
Síndrome Coronario Agudo (SCA) |
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E.1.1.1 | Medical condition in easily understood language |
Heart attack |
Ataque al corazón |
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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 | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051592 |
E.1.2 | Term | Acute coronary syndrome |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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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 estimate the bleeding risk with rivaroxaban compared with ASA, in addition to a single antiplatelet agent (a platelet adenosine diphosphate P2Y12 receptor antagonist [P2Y12 inhibitor], clopidogrel or ticagrelor), in subjects with a recent ACS (including ST-segment elevation myocardial infarction [STEMI] and non-ST-segment elevation acute coronary syndrome [NSTE-ACS]). |
Estimar el riesgo de hemorragia con rivaroxabán, en comparación con AAS, además de un único antiagregante plaquetario (un antagonista del receptor plaquetario P2Y12 de adenosina difosfato [inhibidor del P2Y12], clopidogrel o ticagrelor), en pacientes con SCA reciente (incluido el infarto de miocardio con elevación del segmento ST [STEMI] y síndrome coronario agudo sin elevación del segmento ST [SCASEST]). |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Participants, 18 years or older, must have symptoms suggestive of acute coronary syndrome (ACS) (angina, or symptoms thought to be equivalent) within 48 hours of hospital presentation, or developed ACS while being hospitalized, and has a diagnosis of: a) ST segment elevation myocardial infarction (STEMI); b) non-ST-segment elevation acute coronary syndrome (NSTE-ACS). However, participant who is 54 years of age or younger must also have either diabetes mellitus or a history of a prior myocardial infarction (MI), in addition to the presenting ACS event - Participant must be randomized within the screening window of 10 days after hospital admission for the index ACS event. Participant should have received acute phase treatment for the index ACS, such as intravenous anticoagulant or antiplatelet, and are receiving maintenance dual antiplatelet therapy (DAPT) with either clopidogrel plus acetyl salicylic acid (ASA), or ticagrelor plus ASA, with the intent to continue the treatment with a platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor) after randomization - Participants must agree to provide a pharmacogenomics deoxyribonucleic acid (DNA) sample |
- Los participantes, de 18 años o más, deben tener síntomas que sugieran un síndrome coronario agudo (SCA) (angina o síntomas considerados equivalentes) dentro de las 48h siguientes al ingreso hospitalario, o haber desarrollado SCA mientras estaba hospitalizado, y tener un diagnóstico de: a) Infarto de miocardio con elevación del segmento ST (STEMI); b) síndrome coronario agudo sin elevación del segmento ST(NSTE-ACS). Sin embargo, los participantes de 54 años de edad o menos deberán presentar diabetes mellitus o tener antecedentes de infarto de miocardio previo además del evento de SCA. - El participante debe ser aleatorizado dentro de la ventana del periodo de selección (como máximo 10 días después de ser admitido en el hospital por el SCA). El participante debe haber recibido tratamiento en la fase aguda del SCA, tales como anticoagulante o antiagregante plaquetario intravenoso, y estar recibiendo terapia de mantenimiento antiplaquetario dual (DAPT) con, o bien clopidogrel y Ácido Acetil Salicílico o con Ticagrelor y Ácido Acetil Salicílico, con la intención de continuar el tratamiento con un antagonista del receptor plaquetario P2Y12 de adenosina difosfato [inhibidor del P2Y12] después de la aleatorización. - Los participantes deben aceder a proporcionar una muestra farmacogenómica de ácido desoxirribonucleico (ADN) |
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E.4 | Principal exclusion criteria |
- Participant has any conditions that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk - Participant with a prior stroke of any etiology or transient ischemic attack (TIA) - Participant who received thrombolytic therapy as treatment for the index ACS event cannot be enrolled in the ticagrelor stratum - Participant has anticipated need for chronic administration of omeprazole or esomeprazole concomitantly with clopidogrel - Participant has known allergy or intolerance to ASA or rivaroxaban |
- Participantes con cualquier condición que, en opinión del investigador, suponga una contraindicación para utilizar terapia anticoagulante o suponga un riesgo inaceptable - Participantes con ictus previo de cualquier etiología o ataque isquémico transitorio (TIA) - Participantes que hayan recibido terapia trombolítica como tratamiento para el SCA no pueden ser incluidos en la rama de ticagrelor - El participante necesita la administración crónica de omeprazol y esomeprazol como medicación concomitante al clopidogrel - El participante tiene una alergia conocida o intolerancia a AAS o rivaroxaban |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of Participants with Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events |
Número de participantes con eventos hemorrágicos clinicamente significativos según clasificación TIMI (Trombolisis en Infarto de Miocardio) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to Day 390 |
Hasta el día 390 |
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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 | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Doble enmascarado |
Double-dummy |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 159 |
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 |
Argentina |
Australia |
Belgium |
Bulgaria |
Canada |
Czech Republic |
Denmark |
France |
Germany |
Hungary |
Italy |
Japan |
Korea, Republic of |
Netherlands |
Poland |
Russian Federation |
Spain |
Sweden |
Turkey |
Ukraine |
United States |
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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
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |