E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute myocardial infarction |
Infarto agudo de miocardio |
|
E.1.1.1 | Medical condition in easily understood language |
Heart attack. |
Ataque al corazón |
|
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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000891 |
E.1.2 | Term | Acute myocardial infarction |
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 |
The primary objective of the study is to assess the clinical efficacy of selatogrel when self-administered upon occurrence of symptoms suggestive of an acute myocardial infarction (AMI) in subjects at risk of having a recurrent AMI. |
El objetivo principal del estudio es evaluar la eficacia clínica de selatogrel cuando se autoadministra ante la aparición de síntomas indicativos de un infarto agudo de miocardio (IAM) en sujetos con riesgo de presentar un IAM recurrente. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to assess the safety of self-administration of selatogrel. |
El objetivo secundario es evaluar la seguridad de la autoadministración de selatogrel. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Signed and dated informed consent prior to any study-mandated procedure • Male or female subject > or = 18 years old at the time of signing the informed consent form • Discharged with a confirmed diagnosis of symptomatic Type 1 acute myocardial infarction ST-elevation myocardial infarction (STEMI) or Non-ST-elevation myocardial infarction (NSTEMI), no longer than 4 weeks prior to randomization • Presence of either a second prior AMI within 1 year of screening or at least 2 of the following risk factors: - Second prior AMI more than 1 year before screening, - Diabetes mellitus defined by ongoing glucose lowering treatment, - Chronic kidney disease with estimated glomerular filtration rate less-than 60 mL/min/1.73 m2, - Multivessel coronary artery disease, - Peripheral artery disease, - Age greater than or equal to 65 years, - Absence of coronary revascularization of the qualifying AMI, - Active daily smoking at screening.
• Successfully self-administered placebo according to the autoinjector Instructions for use during screening |
• Consentimiento informado firmado y fechado antes de cualquier procedimiento exigido por el estudio. • Varones o mujeres > o = 18 años en el momento de firmar el DCI. • Alta con diagnóstico confirmado de IAM tipo 1 sintomático (IMEST o IMSEST 2 ), no más de 4 semanas antes de la aleatorización. • Presencia de un segundo IAM previo en el año previo a la selección o al menos 2 de los siguientes factores de riesgo: - Segundo IAM previo más de 1 año antes de la selección. - Diabetes mellitus definida por un tratamiento hipoglucemiante continuo. - Enfermedad renal crónica con filtración glomerular estimada <60 ml/min/1,73 m 2 . - Enfermedad coronaria de múltiples vasos - Arteriopatía periférica - Ausencia de revascularización coronaria del IAM cualificante - Consumo activo de tabaco a diario en la selección. 5. El sujeto se ha autoadministrado correctamente el placebo siguiendo las instrucciones de uso del autoinyector durante la selección. |
|
E.4 | Principal exclusion criteria |
• Increased risk of serious bleeding including any of the following: - History of intracranial bleed at any time. - Known uncorrected intracranial vascular abnormality. - Gastrointestinal bleed requiring hospitalization or transfusion within 1 year prior to screening. - Already on oral triple antithrombotic therapy (i.e., Dual antiplatelet therapy and oral anticoagulant). - Known liver impairment significantly affecting the hepatic function. - Current dialysis. - Ischemic stroke or transient ischemic attack within 3 months of screening. • Chronic anemia with hemoglobin < 10 g/dL. • Chronic thrombocytopenia with platelet count < 100,000/mm3. • Concomitant diseases or conditions that, in the opinion of the investigator, are not compatible with study participation. • Known hypersensitivity to selatogrel, any of its excipients, or drugs of the P2Y12 class. • Previous exposure to an investigational drug within 3 months prior to randomization. • Participation in another clinical trial with an investigational product or device within 3 months prior to randomization. |
• Mayor riesgo de hemorragia grave, incluida cualquiera de las siguientes circunstancias: - Antecedentes de hemorragia intracraneal en algún momento. - Anomalía vascular intracraneal no corregida conocida. - Hemorragia digestiva con necesidad de hospitalización o transfusión en el año previo a la selección. - Tratamiento antitrombótico triple oral (tratamiento antiagregante plaquetario doble y anticoagulante oral). - Insuficiencia hepática conocida que afecte significativamente a la función hepática (por ejemplo, ascitis, ictericia o signos de coagulopatía). - Diálisis actual. - Ictus isquémico o accidente isquémico transitorio en los 3 meses previos a la selección. • Anemia crónica con hemoglobina <10 g/dl. • Trombocitopenia crónica con recuento de plaquetas <100 000/mm 3 • Enfermedades o afecciones concomitantes que, en opinión del investigador, no sean compatibles con la participación en el estudio • Hipersensibilidad conocida a selatogrel, a cualquiera de sus excipientes o a fármacos del grupo P2Y12 • Exposición previa a un fármaco en investigación en los 3 meses previos a la aleatorización. • Participación en otro ensayo clínico con un producto o dispositivo en investigación en los 3 meses previos a la aleatorización. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• The primary efficacy endpoint is defined as the occurrence of death from any cause, or non-fatal AMI after any study treatment self-administration.
The outcomes will be ranked based on severity, from the most severe to the least severe outcome, as follows: 1. Death (all causes). 2. AMI with compromised electro-hemodynamics. 3. STEMI. 4. High-risk NSTEMI. 5. NSTEMI with peak Cardiac troponin (cTn) > 10 × (upper limit of normal) ULN. 6. None of the above.
The Clinical Event Committee (CEC) will adjudicate all events in a blinded manner. Each outcome will be assessed after each study treatment administration and, for each subject, only the worst outcome will be retained as a primary endpoint.
• The primary safety endpoint is the occurrence of type 3 or 5 treatment-emergent bleeding events according to the Bleeding Academic Research Consortium (BARC) definition. |
• El criterio de valoración principal de la eficacia se define como la aparición de muerte por cualquier causa o IAM no mortal después de la autoadministración de cualquier tratamiento autoadministrado del estudio Los resultados se clasificarán en función de la intensidad, desde el resultado más intenso hasta el menos intenso, como sigue: 1. Muerte (por cualquier causa) 2. IAM con compromiso electrohemodinámico 3. STEMI 4. NSTEMI de alto riesgo 5. NSTEMI con Tnc máxima >10 veces el límite superior de la normalidad (LSN) 6. Ninguno de los anteriores
El Comité de Eventos Clínicos (CEC) adjudicará todos los eventos de manera ciega. Cada resultado se evaluará después de la administración de cada tratamiento del estudio y, para cada sujeto, sólo el peor resultado se mantendrá como criterio de valoración primario.
• El criterio primario de valoración de la seguridad es la aparición de hemorragias de tipo 3 o 5 emergentes del tratamiento según la definición del Bleeding Academic Research Consortium (BARC). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
• Primary efficacy endpoint: Outcome 1, i.e. death (all causes) within 7 days after study treatment administration. Outcomes 2,3,4,5, and 6 within 2 days after any study treatment administration.
• Primary safety endpoint within 2 days after any study treatment administration. |
- Criterio primario de eficacia: Desenlace 1, es decir, muerte (por todas las causas) dentro de los 7 días siguientes a la administración del tratamiento del estudio. Desenlaces 2,3,4,5 y 6 dentro de los 2 días siguientes a la administración de cualquier tratamiento del estudio.
- Criterio primario de seguridad dentro de los 2 días posteriores a la administración de cualquier tratamiento del estudio. |
|
E.5.2 | Secondary end point(s) |
The secondary efficacy endpoint is a composite of death from all causes, non-fatal AMI, or hospitalization or unplanned visit to emergency department for heart failure. |
El criterio de valoración secundario de la eficacia es un compuesto de muerte por todas las causas, IAM no mortal u hospitalización o visita no planificada al servicio de urgencias por insuficiencia cardíaca. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
within 30 days after any study treatment administration |
dentro de los 30 días siguientes a la administración de cualquier tratamiento del estudio |
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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 | 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 | Yes |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 135 |
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 |
Canada |
Israel |
Serbia |
United States |
Austria |
Belgium |
Bulgaria |
Denmark |
Estonia |
Finland |
France |
Germany |
Hungary |
Ireland |
Italy |
Lithuania |
Netherlands |
Norway |
Poland |
Romania |
Slovakia |
Spain |
Switzerland |
United Kingdom |
Czechia |
|
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
|
Last Subject Last Visit. |
Última visita del último paciente |
|
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 | 4 |
E.8.9.1 | In the Member State concerned days | |
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 | 6 |