Status:
UNKNOWN
Japanese Primary Prevention Project With Aspirin
Lead Sponsor:
Ministry of Health, Labour and Welfare, Japan
Collaborating Sponsors:
Japan Heart Foundation
Bayer
Conditions:
Hypertension
Hyperlipidemia
Eligibility:
All Genders
60-85 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to investigate the balance between the risks and benefits of primary prevention by Aspirin in elderly Japanese patients with one or more cerebro/cardiovascular risk factor...
Detailed Description
Cerebro/cardiovascular (CV) death accounts for approximately 30% of total deaths in Japan and therefore it is important to establish a preventive treatment for CV events from the point of public healt...
Eligibility Criteria
Inclusion
- Elderly patients not previously diagnosed to have any arteriosclerotic disease, including coronary artery disease or cerebrovascular disease, but meeting any one or more of the following criteria (or on medication for any one or more of the following conditions).
- Hypertension: SBP ≥ 140 mmHg or DBP ≥ 90 mmHg
- Hyperlipidemia: Hypercholesterolemia (total cholesterol ≥ 220 mg/dL or LDL cholesterol ≥ 140 mg/dL) or Hypertriglyceridemia (Triglycerides ≥ 150 mg/dL) or Low-HDL cholesterolemia (HDL cholesterol \< 40 mg/dL)
- Diabetes: Fasting morning blood glucose ≥ 126 mg/dL or casual blood glucose ≥ 200 mg/dL or blood glucose at 2 hrs in the 75-g glucose tolerance test ≥ 200 mg/dL, or HbA1c ≥ 6.5%
- Age: 60 to 85 years
- Patients who can give written consent for participation in the study
Exclusion
- Patients with a history of coronary artery disease or cerebrovascular disease (including transient ischemic attack)
- Patients with arteriosclerotic disease requiring surgery or intervention
- Patients who have or may have atrial fibrillation
- Patients being treated with aspirin, other antiplatelet agents or anticoagulants
- Patients using NSAIDs chronically
- Patients with a history of hypersensitivity to aspirin or salicylic acid
- Patients with peptic ulcers
- Patients with a bleeding tendency
- Patients with serious blood abnormalities
- Patients with aspirin-sensitive asthma or a history of the same
- Patients who are otherwise judged by the investigator to be unsuitable for enrollment in the study.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2010
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT00225849
Start Date
March 1 2005
End Date
September 1 2010
Last Update
September 26 2005
Active Locations (1)
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1
Keio University School of Medicine
Tokyo, Tokyo, Japan, 160-8582