Japanese Primary Prevention Project With Aspirin

Phase 4

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 factors

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 health. The guidelines proposed by a joint study group centering on the Japanese Circulation Society, recommend administration of aspirin to patients with multiple risk factors for primary prevention of arteriosclerotic diseases. In addition, the 2002 AHA guidelines recommend use of aspirin in patients with a 10% or higher 10-year risk of CV events. However, these descriptions are founded on randomized, comparative study results and epidemiological data obtained outside Japan, while no epidemiological data are available in Japan that would allow prediction and selection of patients who could benefit from primary prevention with aspirin. Although the benefit of aspirin for secondary prevention has been proven in Japanese patients, the benefits of primary prevention are still controversial.

JPPP is a multicenter, open-label, centrally randomized, controlled trial. In total, 10,000 elderly patients with one or more CV risk factors (age 60-85 years combined with hypertension, hyperlipidemia, and/or diabetes) will be assigned to enteric-coated aspirin (100mg/day) or control. The primary endpoint is composite event of CV death, nonfatal stroke (of any cause) and nonfatal myocardial infarction.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Composite event of cerebro/cardiovascular (CV) death, nonfatal cerebral stroke (of any cause) and nonfatal myocardial infarction (MI)

Secondary Outcome Measures

Name	Time	Method
CV death
Non CV death
Nonfatal cerebral stroke
Nonfatal MI
Angina pectoris
Transient ischemic attack
Arteriosclerotic disease requiring surgery or intervention
Extracranial bleeding requiring transfusion or admission
Severe side-effects that lead to interruption of the study medication.

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