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- Ensayo clínico NCT02110303
DIAMOND - Dual Antiplatelet Therapy to Reduce Myocardial Injury (DIAMOND)
Dual Antiplatelet Therapy to Inhibit Coronary Atherosclerosis and Myocardial Injury in Patients With Necrotic High-Risk Coronary Plaque Disease
Heart attacks are most commonly caused by rupture of fatty deposits (plaques) within the wall of heart blood vessels. It appears that this process can also frequently occur without causing any symptoms and these events likely explain the development of narrowing within the heart arteries which can subsequently produce symptoms of angina (chest pain).
Previous research has shown a specialised scanner known as a PET (positron emission tomography) scan can identify these recently ruptured plaques in patients without symptoms of a heart attack and these patients have changes on a blood test (troponin) which suggest that they are at higher risk of having a heart attack in the future. This study aims to identify these patients using the PET scan and then see if the markers of increased heart attack risk can be reduced by the use of a blood thinning medication (ticagrelor) which is already a well recognised treatment for people who have suffered a recent heart attack.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Lothian
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Edinburgh, Lothian, Reino Unido, EH16 4SA
- Edinburgh Heart Centre
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients aged ≥40 years with angiographically proven multivessel coronary artery disease defined as at least two major epicardial vessels with any combination of either (a) >50% luminal stenosis, or (b) previous revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery).
- Provision of informed consent prior to any study specific procedures
Exclusion Criteria:
- An acute coronary syndrome within the last 12 months
- An indication for dual anti-platelet therapy, such as drug eluting stent
- Inability to take aspirin
- Receiving thienopyridine therapy such as clopidogrel or prasugrel
- Percutaneous coronary intervention or coronary artery bypass graft surgery within the last 3 months
- Inability or unwilling to give informed consent
- Woman with child-bearing potential and who are breastfeeding will not be enrolled into the trial (woman who have experienced menarche, are pre-menopausal, have not been sterilised or who are currently pregnant)
- Known hypersensitivity to ticagrelor or one of its excipients
- Active pathological bleeding or bleeding diathesis
- Significant thrombocytopenia: <100 x 10^9 /L
- History of intracranial haemorrhage
- Moderate to severe liver impairment (Child's Grade B or C)
- Maintenance therapy with strong cytochrome P450 3A4 (CYP3A4) inhibitors, such as ketoconazole, nefazodone, ritonavir, indinavir, atazanavir, or clarithromycin
- Major intercurrent illness or life expectancy <1 year
- Renal dysfunction (eGFR ≤30 mL/min/1.73 m2)
- Contraindication to iodinated contrast agents
- Planned coronary revascularization or major non-cardiac surgery in the next 12 months
- Maintenance therapy with simvastatin at doses greater than 40mg daily
- Receiving oral anticoagulants including warfarin, rivaroxaban, dabigatran or apixaban.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 18F-F Positive - Ticagrelor
Ticagrelor oral tablets, one (90mg) tablet, twice daily, 12 month duration
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oral, 90mg tablets, twice daily, 12 month duration
Otros nombres:
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Comparador de placebos: 18F-F Positive - Placebo
Identical placebo, one tablet, twice daily, 12 month duration
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Oral tablet (identical to ticagrelor), twice daily, 12 month duration
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Experimental: 18F-F Negative - Ticagrelor
Ticagrelor oral tablets, one (90mg) tablet, twice daily, 12 month duration
|
oral, 90mg tablets, twice daily, 12 month duration
Otros nombres:
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Comparador de placebos: 18F-F Negative - Placebo
Identical placebo, one tablet, twice daily, 12 month duration
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Oral tablet (identical to ticagrelor), twice daily, 12 month duration
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Plasma high sensitivity cardiac troponin I (hsTnI) concentration in patients with coronary 18F-fluoride uptake.
Periodo de tiempo: 30 days
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30 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Plasma hsTnI concentrations in patients without coronary 18F-fluoride uptake.
Periodo de tiempo: 30 days
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30 days
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High sensitivity cardiac troponin I (hsTnI) concentration in total study population.
Periodo de tiempo: 30 days
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30 days
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Plasma high-sensitivity troponin (hsTnI) concentration
Periodo de tiempo: 1 year
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In total population and in 18F-F PET positive and negative sub-groups
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1 year
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Calcium score and plaque volume at the site of baseline coronary 18F-fluoride uptake
Periodo de tiempo: 1 year
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1 year
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: David E. Newby, PhD, University of Edinburgh
- Investigador principal: Philip D. Adamson, MBChB, University of Edinburgh
Publicaciones y enlaces útiles
Publicaciones Generales
- Joshi NV, Vesey AT, Williams MC, Shah AS, Calvert PA, Craighead FH, Yeoh SE, Wallace W, Salter D, Fletcher AM, van Beek EJ, Flapan AD, Uren NG, Behan MW, Cruden NL, Mills NL, Fox KA, Rudd JH, Dweck MR, Newby DE. 18F-fluoride positron emission tomography for identification of ruptured and high-risk coronary atherosclerotic plaques: a prospective clinical trial. Lancet. 2014 Feb 22;383(9918):705-13. doi: 10.1016/S0140-6736(13)61754-7. Epub 2013 Nov 11.
- Dweck MR, Chow MW, Joshi NV, Williams MC, Jones C, Fletcher AM, Richardson H, White A, McKillop G, van Beek EJ, Boon NA, Rudd JH, Newby DE. Coronary arterial 18F-sodium fluoride uptake: a novel marker of plaque biology. J Am Coll Cardiol. 2012 Apr 24;59(17):1539-48. doi: 10.1016/j.jacc.2011.12.037.
- Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
- Moss AJ, Doris MK, Andrews JPM, Bing R, Daghem M, van Beek EJR, Forsyth L, Shah ASV, Williams MC, Sellers S, Leipsic J, Dweck MR, Parker RA, Newby DE, Adamson PD. Molecular Coronary Plaque Imaging Using 18F-Fluoride. Circ Cardiovasc Imaging. 2019 Aug;12(8):e008574. doi: 10.1161/CIRCIMAGING.118.008574. Epub 2019 Aug 6.
- Doris MK, Meah MN, Moss AJ, Andrews JPM, Bing R, Gillen R, Weir N, Syed M, Daghem M, Shah A, Williams MC, van Beek EJR, Forsyth L, Dey D, Slomka PJ, Dweck MR, Newby DE, Adamson PD. Coronary 18F-Fluoride Uptake and Progression of Coronary Artery Calcification. Circ Cardiovasc Imaging. 2020 Dec;13(12):e011438. doi: 10.1161/CIRCIMAGING.120.011438. Epub 2020 Dec 10.
- Moss AJ, Dweck MR, Doris MK, Andrews JPM, Bing R, Forsythe RO, Cartlidge TR, Pawade TA, Daghem M, Raftis JB, Williams MC, van Beek EJR, Forsyth L, Lewis SC, Lee RJ, Shah ASV, Mills NL, Newby DE, Adamson PD. Ticagrelor to Reduce Myocardial Injury in Patients With High-Risk Coronary Artery Plaque. JACC Cardiovasc Imaging. 2020 Jul;13(7):1549-1560. doi: 10.1016/j.jcmg.2019.05.023. Epub 2019 Aug 14.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Isquemia miocardica
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedad coronaria
- Enfermedad de la arteria coronaria
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Inhibidores de la agregación plaquetaria
- Antagonistas del receptor P2Y purinérgico
- Antagonistas del receptor P2 purinérgico
- Antagonistas purinérgicos
- Agentes Purinérgicos
- Ticagrelor
Otros números de identificación del estudio
- DIAMOND-14/SS/0089
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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