The Study on Profile and Genetic Factors of Aspirin Resistance (ProGEAR Study)
This study has been completed.
Sponsor:
Ministry of Health, Labour and Welfare, Japan
Collaborator:
The National Institute of Biomedical Innovation
Information provided by (Responsible Party):
Toshiyuki Miyata, National Cerebral and Cardiovascular Center
ClinicalTrials.gov Identifier:
NCT00250380
First received: November 7, 2005
Last updated: December 12, 2011
Last verified: December 2011
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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: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Study on Profile and Genetic Factors of Aspirin Resistance (ProGEAR Study)－A Prospective Multicenter Cohort Study- |
Resource links provided by NLM:
Further study details as provided by Ministry of Health, Labour and Welfare, Japan:
Biospecimen Retention: Samples With DNA
Detailed Description:
whole blood, serum, urine
| Enrollment: | 583 |
| Study Start Date: | November 2005 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
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 |
| Sampling Method: | Probability Sample |
Study Population
out-patient clinic
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00250380
Locations
| Japan | |
| National Fukuoka-Higashi Medical Center | |
| Koga, Fukuoka, Japan, 8113195 | |
| Hokkaido Neurosurgical Memorial Hospital | |
| Sapporo, Hokkaido, Japan, 0600022 | |
| Nakamura Memorial Hospital | |
| Sapporo, Hokkaido, Japan, 0600061 | |
| Ohnishi Neurological Center | |
| Akashi, Hyogo, Japan, 674-0064 | |
| Higashi Takarazuka Satoh Hospital | |
| Takarazuka, Hyogo, Japan, 6650973 | |
| Kagawa University School of Medicine | |
| Kida-gun, Kagawa, Japan, 7610793 | |
| Tokai University School of Medicine | |
| Isehara, Kanagawa, Japan, 2591193 | |
| Mie University Graduate School of Medicine | |
| Tsu, Mie, Japan, 5148507 | |
| Kohnan Hospital | |
| Sendai, Miyagi, Japan, 9828523 | |
| Nara Medical University | |
| Kashihara, Nara, Japan, 6348521 | |
| Sado Hospital | |
| Sado, Niigata, Japan, 9521209 | |
| Kawasaki Medical School | |
| Kurashiki, Okayama, Japan, 7010192 | |
| Osaka University Graduate School of Medicine | |
| Suita, Osaka, Japan, 5650871 | |
| National Cardiovascular Center | |
| Suita, Osaka, Japan, 5658565 | |
| National Hospital Organization Ureshino Medical Center | |
| Fujitsu-gun, Saga, Japan, 8430393 | |
| Jichi Medical School | |
| Kawachi-gun, Tochigi, Japan, 3290498 | |
| Research Institute for Brain and Blood Vessels Akita | |
| Akita, Japan, 0100874 | |
| Kumamoto University Graduate School of Medicine | |
| Kumamoto, Japan, 8608556 | |
| Nagoya City University Graduate School of Medical Sciences | |
| Nagoya, Japan, 4678602 | |
| Tokyo Women's Medical University | |
| Tokyo, Japan, 1628666 | |
| Tokyo Metropolitan Ebara Hospital | |
| Tokyo, Japan, 1450065 | |
| Teikyo University | |
| Tokyo, Japan, 1738606 | |
| Nippon Medical School Hospital | |
| Tokyo, Japan, 1138603 | |
Sponsors and Collaborators
Ministry of Health, Labour and Welfare, Japan
The National Institute of Biomedical Innovation
Investigators
| Principal Investigator: | Toshiyuki Miyata, PhD | National Cardiovascular Center, Research Institute, |
| Principal Investigator: | Shigeki Miyata, MD | National Cerebral and Cardiovascular Center |
| Principal Investigator: | Kazuo Minematsu, MD | National Cerebral and Cardiovascular Center |
| Principal Investigator: | Masafumi Kitakaze, MD, PhD | National Cerebral and Cardiovascular Center |
| Principal Investigator: | Kazuyuki Nagatsuka, MD, PhD | National Cerebral and Cardiovascular Center |
| Principal Investigator: | Atsushi Kawamura, MD, PhD | National Cerebral and Cardiovascular Center |
| Principal Investigator: | Akiko Kada, MPH | National Cerebral and 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
No publications provided
| Responsible Party: | Toshiyuki Miyata, Director, National Cerebral and Cardiovascular Center |
| ClinicalTrials.gov Identifier: | NCT00250380 History of Changes |
| Other Study ID Numbers: | H17-CV(Seishu)-002 |
| Study First Received: | November 7, 2005 |
| Last Updated: | December 12, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Ministry of Health, Labour and Welfare, Japan:
|
Aspirin Platelet Aggregation Inhibitors |
Additional relevant MeSH terms:
|
Cerebral Infarction Stroke Ischemic Attack, Transient Coronary Disease Coronary Artery Disease Infarction Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Myocardial Ischemia |
Heart Diseases Arteriosclerosis Arterial Occlusive Diseases Ischemia Pathologic Processes Necrosis Aspirin Platelet Aggregation Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013