The Study on Profile and Genetic Factors of Aspirin Resistance (ProGEAR Study)
- Conditions
- Cerebral InfarctionIschemic Attack, TransientCoronary Disease
- Registration Number
- NCT00250380
- Lead Sponsor
- Ministry of Health, Labour and Welfare, Japan
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 583
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Ohnishi Neurological Center
🇯🇵Akashi, Hyogo, Japan
Sado Hospital
🇯🇵Sado, Niigata, Japan
Osaka University Graduate School of Medicine
🇯🇵Suita, Osaka, Japan
Tokyo Women's Medical University
🇯🇵Tokyo, Japan
Higashi Takarazuka Satoh Hospital
🇯🇵Takarazuka, Hyogo, Japan
Nara Medical University
🇯🇵Kashihara, Nara, Japan
National Cardiovascular Center
🇯🇵Suita, Osaka, Japan
Teikyo University
🇯🇵Tokyo, Japan
National Fukuoka-Higashi Medical Center
🇯🇵Koga, Fukuoka, Japan
Mie University Graduate School of Medicine
🇯🇵Tsu, Mie, Japan
Kohnan Hospital
🇯🇵Sendai, Miyagi, Japan
Jichi Medical School
🇯🇵Kawachi-gun, Tochigi, Japan
Nippon Medical School Hospital
🇯🇵Tokyo, Japan
Hokkaido Neurosurgical Memorial Hospital
🇯🇵Sapporo, Hokkaido, Japan
National Hospital Organization Ureshino Medical Center
🇯🇵Fujitsu-gun, Saga, Japan
Kumamoto University Graduate School of Medicine
🇯🇵Kumamoto, Japan
Nakamura Memorial Hospital
🇯🇵Sapporo, Hokkaido, Japan
Kagawa University School of Medicine
🇯🇵Kida-gun, Kagawa, Japan
Tokai University School of Medicine
🇯🇵Isehara, Kanagawa, Japan
Kawasaki Medical School
🇯🇵Kurashiki, Okayama, Japan
Research Institute for Brain and Blood Vessels Akita
🇯🇵Akita, Japan
Nagoya City University Graduate School of Medical Sciences
🇯🇵Nagoya, Japan
Tokyo Metropolitan Ebara Hospital
🇯🇵Tokyo, Japan