Japanese Primary Prevention Project With Aspirin

  • STATUS
    Recruiting
  • participants needed
    10000
  • sponsor
    Ministry of Health, Labour and Welfare, Japan
Updated on 7 November 2020
diabetes
hypertension
coronary artery disease
fasting
LDL Cholesterol
hemoglobin a1c
glycosylated hemoglobin
hypercholesterolemia
glucose tolerance test
cholesterol level
cholesterol measurement
hdl cholesterol

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

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.

Details
Condition Diabetes Mellitus, Hypertension, Hyperlipidemia
Treatment Aspirin
Clinical Study IdentifierNCT00225849
SponsorMinistry of Health, Labour and Welfare, Japan
Last Modified on7 November 2020

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