Japanese Primary Prevention Project With Aspirin

• Status: Unknown status
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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 factors

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ministry of Health, Labour and Welfare, Japan
• Collaborators: Bayer; Japan Heart Foundation
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.