Rationale, design, and baseline data of the Japanese Primary Prevention Project (JPPP)—A randomized, open-label, controlled trial of aspirin versus no aspirin in patients with multiple risk factors for vascular events

Received 22 May 2009; accepted 25 November 2009.

Background

Prevention of atherosclerotic disease has become an important public health priority in Japan due to the aging of the population and changes in diet and lifestyle factors.

Methods

The Japanese Primary Prevention Project (JPPP) is a multicenter, open-label, randomized, parallel-group trial that is evaluating primary prevention with low-dose aspirin in Japanese patients aged 60 to 85 years with hypertension, dyslipidemia, or diabetes mellitus. The study cohort will be followed for a mean of 4 years. The primary end point is a composite of death from cardiovascular causes (including fatal myocardial infarction [MI], fatal stroke, and other cardiovascular death), nonfatal stroke (ischemic or hemorrhagic), and nonfatal MI. Key secondary end points include a composite of cardiovascular death, nonfatal stroke, nonfatal MI, transient ischemic attack, angina pectoris, or arteriosclerotic disease requiring surgery or intervention; each component of the primary end point; noncerebrovascular and noncardiovascular death; and extracranial hemorrhage requiring transfusion or hospitalization. End point assessment is done by a central adjudication committee that is blinded to treatment assignments.

Results

Enrollment began in March 2005 and was completed in June 2007. A total of 14,466 patients were randomly allocated to receive enteric-coated aspirin, 100 mg/d, or no aspirin. At randomization, the study cohort had a mean (SD) age of 70.6 (6.2) years; 57.8% were women, 85.0% had hypertension, 71.7% had dyslipidemia, and 33.9% had diabetes. In the study cohort, 80.4% of patients had ≥3 risk factors.

Conclusion

The JPPP is the largest primary prevention trial of aspirin in a Japanese population that is investigating whether the benefit of aspirin in reducing risk of vascular events outweighs any bleeding risk in elderly patients with multiple risk factors.

a Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan

b Department of Cardiology, Jichi Medical University Hospital, Tochigi, Japan

c Department of Neurology, Tokyo Women's Medical University, Tokyo, Japan

d Japan Physicians Association, Japan

e Tsukuba University Hospital, Institute of Clinical Medicine, University of Tsukuba, Ibaraki, Japan

f Department of Medicine, Nippon Medical University, Tokyo, Japan

g Division of Molecular Cardiovascular Metabolism, Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine, Tokyo, Japan

h Division of Preventive Medicine, Department of Community Health and Medicine, Research Institute, International Medical Center of Japan, Tokyo, Japan

i Faculty of Medicine, Department of Clinical Epidemiology and Systems, Graduate School of Medicine, Center for Epidemiology and Preventive Medicine, The University of Tokyo, Tokyo, Japan

j Division of Hematology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan

k Clinical Laboratory, Keio University School of Medicine, Tokyo, Japan

l Major in Life Science and Medical Bioscience Graduate School of Advanced Science and Engineering, Waseda University, Tokyo, Japan

Reprint requests: Tamio Teramoto, MD, PhD, Internal Medicine, Teikyo University School of Medicine, 2-11-1, Kaga, Itabashi-ku, Tokyo 173-8606, Japan.

RCT#:NCT00225849.

PII: S0002-8703(09)00955-7

doi:10.1016/j.ahj.2009.11.030

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