- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00250380
The Study on Profile and Genetic Factors of Aspirin Resistance (ProGEAR Study)
The Study on Profile and Genetic Factors of Aspirin Resistance (ProGEAR Study)-A Prospective Multicenter Cohort Study-
Descripción general del estudio
Estado
Descripción detallada
Primary Outcomes: The primary endpoint is the composite outcomes of cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, percutaneous coronary angiography, thromboembolism, and death caused by cardiovascular disease.
Secondary Outcomes: Platelet aggregation induced by collagen and arachidonic acid, serum thromboxane B2, urine 11-dehydrothromboxane B2, platelet thrombus formation under flow conditions (sub-study only at the National Cardiovascular Center)
The primary objective of this study is to determine the markers for aspirin resistance. To achieve this objective, platelet aggregation, serum thromboxane B2, and urine 11-dehydrothromboxane B2 are measured in patients receiving usual therapeutic doses of aspirin, who experienced acute coronary syndrome, cerebral infarction, or transient ischemic attack occurred in a period between the past 1 month and the past 2 years. This is a multi-center, prospective study.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Akita, Japón, 0100874
- Research Institute for Brain and Blood Vessels Akita
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Kumamoto, Japón, 8608556
- Kumamoto University Graduate School of Medicine
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Nagoya, Japón, 4678602
- Nagoya City University Graduate School of Medical Sciences
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Tokyo, Japón, 1138603
- Nippon Medical School Hospital
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Tokyo, Japón, 1450065
- Tokyo Metropolitan Ebara Hospital
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Tokyo, Japón, 1628666
- Tokyo Women's Medical University
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Tokyo, Japón, 1738606
- Teikyo University
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Fukuoka
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Koga, Fukuoka, Japón, 8113195
- National Fukuoka-Higashi Medical Center
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Hokkaido
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Sapporo, Hokkaido, Japón, 0600022
- Hokkaido Neurosurgical Memorial Hospital
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Sapporo, Hokkaido, Japón, 0600061
- Nakamura Memorial Hospital
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Hyogo
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Akashi, Hyogo, Japón, 674-0064
- Ohnishi Neurological Center
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Takarazuka, Hyogo, Japón, 6650973
- Higashi Takarazuka Satoh Hospital
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Kagawa
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Kida-gun, Kagawa, Japón, 7610793
- Kagawa University School of Medicine
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Kanagawa
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Isehara, Kanagawa, Japón, 2591193
- Tokai University School of Medicine
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Mie
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Tsu, Mie, Japón, 5148507
- Mie University Graduate School of Medicine
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Miyagi
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Sendai, Miyagi, Japón, 9828523
- Kohnan Hospital
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Nara
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Kashihara, Nara, Japón, 6348521
- Nara Medical University
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Niigata
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Sado, Niigata, Japón, 9521209
- Sado Hospital
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Okayama
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Kurashiki, Okayama, Japón, 7010192
- Kawasaki Medical School
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Osaka
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Suita, Osaka, Japón, 5658565
- National Cardiovascular Center
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Suita, Osaka, Japón, 5650871
- Osaka University Graduate School of Medicine
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Saga
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Fujitsu-gun, Saga, Japón, 8430393
- National Hospital Organization Ureshino Medical Center
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Tochigi
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Kawachi-gun, Tochigi, Japón, 3290498
- Jichi Medical School
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
Adult males or females who met the criteria listed below:
- Patients who had acute coronary syndrome, cerebral infarction (except cardioembolic stroke), or transient ischemic attack between past 28 days and the past 2 years
- patients who receive long-term aspirin therapy (at least 28 days)
- Patients who are >=20 years of age
- Patients willing and able to give written informed consent
Exclusion Criteria:
- Malignancy or suspected malignancy
- Patients who showed platelet counts less than 100,000/uL or more than 450,000/uL
- Congenital bleeding tendency
- Patients who receive other antiplatelet drugs or warfarin
- Patients with atrial fibrillation
- Patients who received surgical operation or catheter intervention within the past 2 weeks
- Patients who received anticoagulation drug therapy including heparin ( low-molecular weight heparin) and danaparoid.
- Patients with more than modified Rankin scale 4
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Toshiyuki Miyata, PhD, National Cardiovascular Center, Research Institute,
- Investigador principal: Shigeki Miyata, MD, National Cerebral and Cardiovascular Center
- Investigador principal: Kazuo Minematsu, MD, National Cerebral and Cardiovascular Center
- Investigador principal: Masafumi Kitakaze, MD, PhD, National Cerebral and Cardiovascular Center
- Investigador principal: Kazuyuki Nagatsuka, MD, PhD, National Cerebral and Cardiovascular Center
- Investigador principal: Atsushi Kawamura, MD, PhD, National Cerebral and Cardiovascular Center
- Investigador principal: Akiko Kada, MPH, National Cerebral and Cardiovascular Center
- Investigador principal: Shinichiro Uchiyama, MD, Tokyo Women's Medical University
- Investigador principal: Takehiko Nagao, MD, PhD, Tokyo Metropolitan Ebara Hospital
- Investigador principal: Naohisa Hosomi, MD, PhD, Kagawa University School of Medicine
- Investigador principal: Takemori Yamawaki, MD, PhD, Nagoya City University Graduate School of Medical Science
- Investigador principal: Kazumi Kimura, MD, PhD, Kawasaki Medical School
- Investigador principal: Kozue Saito, MD, Nara Medical University
- Investigador principal: Hiroshi Nakane, MD, National Fukuoka-Higashi Medical Center
- Investigador principal: Jyoji Nakagawara, MD, Nakamura Memorial Hospital
- Investigador principal: Shinya Goto, MD, Tokai University School of Medicine
- Investigador principal: Takaaki Isshiki, MD, Teikyo University
- Investigador principal: Kazuo Kitagawa, MD, Osaka University Graduate School of Medicine
- Investigador principal: Kazuomi Kario, MD, Jichi Medical School
- Investigador principal: Hideo Wada, MD, PhD, Mie University Graduate School of Medicine
- Investigador principal: Ken Nagata, MD, Research Institute for Brain and Blood Vessels Akita
- Investigador principal: Koichi Kaikita, MD, Kumamoto University Graduate School of Medicine
- Investigador principal: Keiji Tanaka, MD, Nippon Medical School Hospital
- Investigador principal: Akira Hattori, MD, Sado Hospital
- Investigador principal: Eisuke Furui, MD, PhD, Kohnan Hospital
- Investigador principal: Yoshihiko Saito, MD, PhD, Nara Medical University
- Investigador principal: Satoshi Ueno, MD, Nara Medical University
- Investigador principal: Yasuo Katayama, MD, Nippon Medical School Hospital
- Investigador principal: Takeo Abumiya, MD, Hokkaido Neurosurgical Memorial Hospital
- Investigador principal: Masakatsu Nishikawa, MD, Mie University Graduate School of Medicine
- Investigador principal: Shin Takiuchi, MD, PhD, Higashi Takarazuka Satoh Hospital
- Investigador principal: Hideyuki Ohnishi, MD, Ohnishi Neurological Center
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Isquemia
- Procesos Patológicos
- Necrosis
- Isquemia miocardica
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Isquemia cerebral
- Carrera
- Infarto cerebral
- Infarto
- Enfermedad coronaria
- Ataque Isquémico, Transitorio
- Infarto cerebral
Otros números de identificación del estudio
- H17-CV(Seishu)-002
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