E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Effectiveness study of complete versus culprit-only revascularization strategies to treat multi vessel disease after primary PCI for STEMI |
Estudio de efectividad de revascularización completa frente solo a la causante para tratar la enfermedad de vasos múltiples después de ICP primaria por STEMI |
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E.1.1.1 | Medical condition in easily understood language |
revascularization in myocardial infarct |
revascularización en infartados. |
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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 determine whether, on a background of optimal medical therapy with low dose ASA and ticagrelor, a strategy of multi-vessel revascularization involving staged PCI using drug eluting stents of all suitable non-infarct related artery lesions is superior to a strategy of culprit lesion only revascularization in reducing the composite outcome of CV death or new MI in patients with multi-vessel disease who have undergone successful culprit lesion primary PCI for STEMI. |
Determinar, si con un tratamiento médico óptimo con dosis bajas de AAS y ticagrelor, una estrategia de revascularización de múltiples vasos que implica etapa de intervención percutánea coronaria utilizando stents liberadores de fármacos de todas las lesiones arteriales adecuadas no relacionadas con el infarto, es superior a una estrategia de revascularización solo de la lesión culpable en la disminución del endpoint combinado de muerte cardiovascular o nuevo infarto de miocardio en pacientes con enfermedad de múltiples vasos que han sido sometidos con éxito a intervención percutánea coronaria de la lesión culpable para la elevación del segmento ST infarto de miocardio. |
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E.2.2 | Secondary objectives of the trial |
1. To determine whether complete revascularization reduces the composite of CV death, new MI or ischemia-driven revascularization 2. To determine whether the initial strategy of complete revascularization improves angina control, as assessed by the Seattle Angina Questionnaire (SAQ) Frequency Scale, and health-related quality of life, as assessed by the EQ-5D Quality of Life scale at 6 months and 5 year/final follow up compared to baseline. |
1. Determinar si la revascularización completa reduce el endpoint combinado de muerte cardiovascular, nuevo infarto de miocardio o la revascularización inducida por isquemia. 2. Determinar si la estrategia inicial de la revascularización completa mejora el control de la angina de pecho, evaluada según la Escala de Frecuencia de la Seattle Angina Questionnaire (SAQ), y la calidad de vida relacionada con la salud, evaluada según la Escala de calidad de vida (EQ-5D), a los 6 meses y 5 años/final de seguimiento respecto al valor basal. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Men and women within 72 hours after successful PCI (preferably using a drug eluting stent) to the culprit lesion for STEMI. PCI for STEMI can be either primary PCI or rescue PCI for failed fibrinolysis or a pharmacoinvasive strategy where PCI is performed routinely 3-12 hours after initiation of fibrinolysis AND 2. Multi-vessel disease defined as at least 1 additional non-infarct related coronary artery lesion that is at least 2.5 mm in diameter that has not been stented as part of the primary PCI and that is amenable to successful treatment with PCI and has: (i) at least 70% diameter stenosis (visual estimation) or (ii) at least 50% diameter stenosis (visual estimation) with fractional flow reserve (FFR) ? 0.80 |
1. Hombres y mujeres dentro de las 72 horas después intervención coronaria percutánea (ICP) con buen resultado (preferiblemente usando un stent liberador de fármaco) de la lesión causante de STEMI. ICP para STEMI puede ser ICP primaria o ICP de rescate para la fibrinólisis fallida o una estrategia farmacoinvasiva donde PCI se realiza rutinariamente 3-12 horas después del inicio de la fibrinólisis 2.Enfermedad de múltiples vasos definida como al menos 1 no infarto adicional relacionado con lesión de la arteria coronaria que tenga al menos 2,5 mm de diámetro, que no haya sido estenosada como parte de la ICO primaria y que sea susceptible de obtener un buen resultado en el tratamiento con PCI y tiene: (i) al menos una stenos de 70% de diámetro (estimación visual) o (ii) a al menos una stenos de 50% de diámetro (estimación visual) con reserva fraccional de flujo ? 0,80 |
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E.4 | Principal exclusion criteria |
1. Planned revascularization of non-culprit lesion 2. Planned surgical revascularization 3. Non-cardiovascular co-morbidity reducing life expectancy to < 5 years 4. Any factor precluding 5 year follow-up 5. Prior Coronary Artery Bypass Graft (CABG) Surgery |
1.Revascularización planificada de la lesión no culpable 2.Revascularización quirúrgica planificada 3.Comorbilidad no cardiovascular que reduzca la esperanza de vida <5 años 4.Cualquier factor que impida 5 años de seguimiento 5.Cirugía previa de Bypass de Arterias Coronarias |
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E.5 End points |
E.5.1 | Primary end point(s) |
Cardiovascular death or new myocardial infarction |
Muerte cardiovascular o nuevo infarto de miocardio |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
until death or new event |
hasta que se produzca la muerte o nuevo evento |
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E.5.2 | Secondary end point(s) |
1. Composite of CV death, new MI or ischemia-driven revascularization. 2. Changes in Angina Status as per Seattle Angina Questionnaire Angina Frequency Scale and changes in health-related quality of life from baseline, at 6 months and 5 year/final visit, based on the EQ-5D Quality of Life Scale. |
1Conjunto de muerte cardiovascular, nuevo infarto de miocardio o revascularización isquémica. 2-Cambios en el estado de la angina según la escala de frecuencia de questionario de Angina de Seattle y los cambios en la calidad de vida en estado basal a los 6 meses y 5 años / visita final acorde la escala EQ-5D. |
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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 | No |
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 | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
ciego para el evaluador |
blinded assessment of outcomes |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 150 |
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 |
Austria |
Belgium |
Brazil |
Bulgaria |
Canada |
Chile |
China |
Croatia |
Czech Republic |
Denmark |
Estonia |
Finland |
France |
Germany |
Greece |
Hungary |
India |
Israel |
Italy |
Latvia |
Lithuania |
Macedonia, the former Yugoslav Republic of |
Malaysia |
Mexico |
New Zealand |
Norway |
Poland |
Romania |
Russian Federation |
Serbia |
Singapore |
Slovenia |
South Africa |
Spain |
Sweden |
Switzerland |
United Kingdom |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |