Status:
COMPLETED
The Study on Profile and Genetic Factors of Aspirin Resistance (ProGEAR Study)
Lead Sponsor:
Ministry of Health, Labour and Welfare, Japan
Collaborating Sponsors:
The National Institute of Biomedical Innovation
Conditions:
Coronary Disease
Cerebral Infarction
Eligibility:
All Genders
20+ years
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 event...
Detailed Description
Primary Outcomes: The primary endpoint is the composite outcomes of cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, percutaneous coronary angiography, thromboem...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
583 Patients enrolled
Trial Details
Trial ID
NCT00250380
Start Date
November 1 2005
End Date
March 1 2011
Last Update
December 13 2011
Active Locations (23)
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1
Research Institute for Brain and Blood Vessels Akita
Akita, Akita, Japan, 0100874
2
National Fukuoka-Higashi Medical Center
Koga, Fukuoka, Japan, 8113195
3
Hokkaido Neurosurgical Memorial Hospital
Sapporo, Hokkaido, Japan, 0600022
4
Nakamura Memorial Hospital
Sapporo, Hokkaido, Japan, 0600061