Hypertension Clinical Trial
Official title:
Japanese Primary Prevention Project With Aspirin in the Elderly With One or More Risk Factors of Vascular Events: JPPP
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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