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| Sponsors and Collaborators: |
Japanese Ministry of Health, Labor and Welfare The Program for Promotion of Fundamental Studies in Health Sciences of the National Institute of Biomedical Innovation (NIBIO) of Japan |
|---|---|
| Information provided by: | Ministry of Health, Labour and Welfare |
| ClinicalTrials.gov Identifier: | NCT00250380 |
Purpose
The purpose of this study is to determine the clinically meaningful definition and prevalence of aspirin resistance based on data linking aspirin-dependent laboratory tests to recurrent vascular events in cardiovascular patients taking aspirin.
| Study Type: | Observational |
| Study Design: | Prospective |
| Estimated Enrollment: | 600 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | September 2009 |
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.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adult males or females who met the criteria listed below:
Exclusion Criteria:
Contacts and Locations| Contact: Toshiyuki Miyata, PhD | 81-6-6833-5012 ext 2512 | miyata@ri.ncvc.go.jp |
| Contact: Shigeki Miyata, MD | 81-6-6833-5012 ext 8084 | smiyata@hsp.ncvc.go.jp |
Show 23 Study Locations| Principal Investigator: | Toshiyuki Miyata, PhD | National Cardiovascular Center, Research Institute, |
| Principal Investigator: | Shigeki Miyata, MD | National Cardiovascular Center |
| Principal Investigator: | Kazuo Minematsu, MD | National Cardiovascular Center |
| Principal Investigator: | Masafumi Kitakaze, MD, PhD | National Cardiovascular Center |
| Principal Investigator: | Kazuyuki Nagatsuka, MD, PhD | National Cardiovascular Center |
| Principal Investigator: | Atsushi Kawamura, MD, PhD | National Cardiovascular Center |
| Principal Investigator: | Akiko Kada, MPH | National Cardiovascular Center |
| Principal Investigator: | Shinichiro Uchiyama, MD | Tokyo Women's Medical University |
| Principal Investigator: | Takehiko Nagao, MD, PhD | Tokyo Metropolitan Ebara Hospital |
| Principal Investigator: | Naohisa Hosomi, MD, PhD | Kagawa University School of Medicine |
| Principal Investigator: | Takemori Yamawaki, MD, PhD | Nagoya City University Graduate School of Medical Science |
| Principal Investigator: | Kazumi Kimura, MD, PhD | Kawasaki Medical School |
| Principal Investigator: | Kozue Saito, MD | Nara Medical University |
| Principal Investigator: | Hiroshi Nakane, MD | National Fukuoka-Higashi Medical Center |
| Principal Investigator: | Jyoji Nakagawara, MD | Nakamura Memorial Hospital |
| Principal Investigator: | Shinya Goto, MD | Tokai University School of Medicine |
| Principal Investigator: | Takaaki Isshiki, MD | Teikyo University |
| Principal Investigator: | Kazuo Kitagawa, MD | Osaka University Graduate School of Medicine |
| Principal Investigator: | Kazuomi Kario, MD | Jichi Medical School |
| Principal Investigator: | Hideo Wada, MD, PhD | Mie University Graduate School of Medicine |
| Principal Investigator: | Ken Nagata, MD | Research Institute for Brain and Blood Vessels Akita |
| Principal Investigator: | Koichi Kaikita, MD | Kumamoto University Graduate School of Medicine |
| Principal Investigator: | Keiji Tanaka, MD | Nippon Medical School Hospital |
| Principal Investigator: | Akira Hattori, MD | Sado Hospital |
| Principal Investigator: | Eisuke Furui, MD, PhD | Kohnan Hospital |
| Principal Investigator: | Yoshihiko Saito, MD, PhD | Nara Medical University |
| Principal Investigator: | Satoshi Ueno, MD | Nara Medical University |
| Principal Investigator: | Yasuo Katayama, MD | Nippon Medical School Hospital |
| Principal Investigator: | Takeo Abumiya, MD | Hokkaido Neurosurgical Memorial Hospital |
| Principal Investigator: | Masakatsu Nishikawa, MD | Mie University Graduate School of Medicine |
| Principal Investigator: | Shin Takiuchi, MD, PhD | Higashi Takarazuka Satoh Hospital |
| Principal Investigator: | Hideyuki Ohnishi, MD | Ohnishi Neurological Center |
More Information
| Study ID Numbers: | H17-CV(Seishu)-002 |
| Study First Received: | November 7, 2005 |
| Last Updated: | May 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00250380 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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Aspirin Platelet Aggregation Inhibitors |
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Arterial Occlusive Diseases Ischemic Attack, Transient Heart Diseases Cerebral Infarction Myocardial Ischemia Stroke Vascular Diseases Central Nervous System Diseases Arteriosclerosis Ischemia |
Brain Diseases Cerebrovascular Disorders Coronary Disease Necrosis Aspirin Brain Ischemia Brain Infarction Infarction Coronary Artery Disease |
|
Pathologic Processes Nervous System Diseases Cardiovascular Diseases |
