title: Aspirin for Stroke Prevention in Elderly Patients With Vascular Risk Factors: Japanese Primary Prevention Project.
abstract: The effect of aspirin in primary prevention of stroke is controversial among clinical trials conducted in Western countries, and no data are available for Asian populations with a high risk of intracranial hemorrhage. The objective of this study was to evaluate the effect of aspirin on the risk of stroke and intracranial hemorrhage in the Japanese Primary Prevention Project (JPPP).
  
  
  
  A total of 14 464 patients (age, 60-85 years) with hypertension, dyslipidemia, and diabetes mellitus participated and were randomized into 2 treatment groups: 100 mg of aspirin or no aspirin. The median follow-up period was 5.02 years.
  
  
  
  The cumulative rate of fatal or nonfatal stroke was similar for the aspirin (2.068%; 95% confidence interval [CI], 1.750-2.443) and no aspirin (2.299%; 95% CI, 1.963-2.692) groups at 5 years; the estimated hazard ratio was 0.927 (95% CI, 0.741-1.160; P=0.509). Aspirin nonsignificantly reduced the risk of ischemic stroke or transient ischemic attack (hazard ratio, 0.783; 95% CI, 0.606-1.012; P=0.061) and nonsignificantly increased the risk of intracranial hemorrhage (hazard ratio, 1.463; 95% CI; 0.956-2.237; P=0.078). A Cox regression adjusted by the risk factors for all stroke, which were age >70 years, smoking, and diabetes mellitus, supported the above result.
  
  
  
  Aspirin did not show any net benefit for the primary prevention of stroke in elderly Japanese patients with risk factors for stroke, whereas age >70 years, smoking, and diabetes mellitus were risk factors for stroke regardless of aspirin treatment.
  
  
  
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00225849.
authors.affiliation: From the Clinical Research Center for Medicine, International University of Health and Welfare, Tokyo, Japan (S.U.); Clinical Trial Department, Cancer Institute Hospital, Tokyo, Japan (N.I.); Department of Cardiology, Shin-Oyama City Hospital, Tochigi, Japan (K.S.); Teikyo Academic Research Center, Teikyo University, Tokyo, Japan (T.T.); Clinical Research Support Center, Center for Epidemiology and Preventive Medicine, The University of Tokyo Hospital, Tokyo, Japan (T.Y.); Diabetes and Life Style Disease Center, Fukujyuji Hospital, Tokyo, Japan (S.O.); Japan Physician's Association, Tokyo, Japan (M.S.); Department of Internal Medicine, Kitamura Memorial Clinic, Tokyo, Japan (K.A.); Department of Laboratory Medicine, Keio University School of Medicine, Tokyo, Japan (M. Murata); Department of Hematology/Oncology, Tokai University Hachioji Hospital, Tokyo, Japan (K.Y.); National Cerebral and Cardiovascular Center, Osaka, Japan (K.M.); Department of Clinical Neuroscience and Therapeutics, Hiroshima University, Hiroshima, Japan (M. Matsumoto); and Graduate School of Advanced Science and Engineering, Waseda University, Tokyo, Japan (Y.I.). suchiyama@iuhw.ac.jp.
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Uchiyama
authors.affiliation: From the Clinical Research Center for Medicine, International University of Health and Welfare, Tokyo, Japan (S.U.); Clinical Trial Department, Cancer Institute Hospital, Tokyo, Japan (N.I.); Department of Cardiology, Shin-Oyama City Hospital, Tochigi, Japan (K.S.); Teikyo Academic Research Center, Teikyo University, Tokyo, Japan (T.T.); Clinical Research Support Center, Center for Epidemiology and Preventive Medicine, The University of Tokyo Hospital, Tokyo, Japan (T.Y.); Diabetes and Life Style Disease Center, Fukujyuji Hospital, Tokyo, Japan (S.O.); Japan Physician's Association, Tokyo, Japan (M.S.); Department of Internal Medicine, Kitamura Memorial Clinic, Tokyo, Japan (K.A.); Department of Laboratory Medicine, Keio University School of Medicine, Tokyo, Japan (M. Murata); Department of Hematology/Oncology, Tokai University Hachioji Hospital, Tokyo, Japan (K.Y.); National Cerebral and Cardiovascular Center, Osaka, Japan (K.M.); Department of Clinical Neuroscience and Therapeutics, Hiroshima University, Hiroshima, Japan (M. Matsumoto); and Graduate School of Advanced Science and Engineering, Waseda University, Tokyo, Japan (Y.I.).
authors.forename: Naoki
authors.initials: N
authors.lastname: Ishizuka
authors.affiliation: From the Clinical Research Center for Medicine, International University of Health and Welfare, Tokyo, Japan (S.U.); Clinical Trial Department, Cancer Institute Hospital, Tokyo, Japan (N.I.); Department of Cardiology, Shin-Oyama City Hospital, Tochigi, Japan (K.S.); Teikyo Academic Research Center, Teikyo University, Tokyo, Japan (T.T.); Clinical Research Support Center, Center for Epidemiology and Preventive Medicine, The University of Tokyo Hospital, Tokyo, Japan (T.Y.); Diabetes and Life Style Disease Center, Fukujyuji Hospital, Tokyo, Japan (S.O.); Japan Physician's Association, Tokyo, Japan (M.S.); Department of Internal Medicine, Kitamura Memorial Clinic, Tokyo, Japan (K.A.); Department of Laboratory Medicine, Keio University School of Medicine, Tokyo, Japan (M. Murata); Department of Hematology/Oncology, Tokai University Hachioji Hospital, Tokyo, Japan (K.Y.); National Cerebral and Cardiovascular Center, Osaka, Japan (K.M.); Department of Clinical Neuroscience and Therapeutics, Hiroshima University, Hiroshima, Japan (M. Matsumoto); and Graduate School of Advanced Science and Engineering, Waseda University, Tokyo, Japan (Y.I.).
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Shimada
authors.affiliation: From the Clinical Research Center for Medicine, International University of Health and Welfare, Tokyo, Japan (S.U.); Clinical Trial Department, Cancer Institute Hospital, Tokyo, Japan (N.I.); Department of Cardiology, Shin-Oyama City Hospital, Tochigi, Japan (K.S.); Teikyo Academic Research Center, Teikyo University, Tokyo, Japan (T.T.); Clinical Research Support Center, Center for Epidemiology and Preventive Medicine, The University of Tokyo Hospital, Tokyo, Japan (T.Y.); Diabetes and Life Style Disease Center, Fukujyuji Hospital, Tokyo, Japan (S.O.); Japan Physician's Association, Tokyo, Japan (M.S.); Department of Internal Medicine, Kitamura Memorial Clinic, Tokyo, Japan (K.A.); Department of Laboratory Medicine, Keio University School of Medicine, Tokyo, Japan (M. Murata); Department of Hematology/Oncology, Tokai University Hachioji Hospital, Tokyo, Japan (K.Y.); National Cerebral and Cardiovascular Center, Osaka, Japan (K.M.); Department of Clinical Neuroscience and Therapeutics, Hiroshima University, Hiroshima, Japan (M. Matsumoto); and Graduate School of Advanced Science and Engineering, Waseda University, Tokyo, Japan (Y.I.).
authors.forename: Tamio
authors.initials: T
authors.lastname: Teramoto
authors.affiliation: From the Clinical Research Center for Medicine, International University of Health and Welfare, Tokyo, Japan (S.U.); Clinical Trial Department, Cancer Institute Hospital, Tokyo, Japan (N.I.); Department of Cardiology, Shin-Oyama City Hospital, Tochigi, Japan (K.S.); Teikyo Academic Research Center, Teikyo University, Tokyo, Japan (T.T.); Clinical Research Support Center, Center for Epidemiology and Preventive Medicine, The University of Tokyo Hospital, Tokyo, Japan (T.Y.); Diabetes and Life Style Disease Center, Fukujyuji Hospital, Tokyo, Japan (S.O.); Japan Physician's Association, Tokyo, Japan (M.S.); Department of Internal Medicine, Kitamura Memorial Clinic, Tokyo, Japan (K.A.); Department of Laboratory Medicine, Keio University School of Medicine, Tokyo, Japan (M. Murata); Department of Hematology/Oncology, Tokai University Hachioji Hospital, Tokyo, Japan (K.Y.); National Cerebral and Cardiovascular Center, Osaka, Japan (K.M.); Department of Clinical Neuroscience and Therapeutics, Hiroshima University, Hiroshima, Japan (M. Matsumoto); and Graduate School of Advanced Science and Engineering, Waseda University, Tokyo, Japan (Y.I.).
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Yamazaki
authors.affiliation: From the Clinical Research Center for Medicine, International University of Health and Welfare, Tokyo, Japan (S.U.); Clinical Trial Department, Cancer Institute Hospital, Tokyo, Japan (N.I.); Department of Cardiology, Shin-Oyama City Hospital, Tochigi, Japan (K.S.); Teikyo Academic Research Center, Teikyo University, Tokyo, Japan (T.T.); Clinical Research Support Center, Center for Epidemiology and Preventive Medicine, The University of Tokyo Hospital, Tokyo, Japan (T.Y.); Diabetes and Life Style Disease Center, Fukujyuji Hospital, Tokyo, Japan (S.O.); Japan Physician's Association, Tokyo, Japan (M.S.); Department of Internal Medicine, Kitamura Memorial Clinic, Tokyo, Japan (K.A.); Department of Laboratory Medicine, Keio University School of Medicine, Tokyo, Japan (M. Murata); Department of Hematology/Oncology, Tokai University Hachioji Hospital, Tokyo, Japan (K.Y.); National Cerebral and Cardiovascular Center, Osaka, Japan (K.M.); Department of Clinical Neuroscience and Therapeutics, Hiroshima University, Hiroshima, Japan (M. Matsumoto); and Graduate School of Advanced Science and Engineering, Waseda University, Tokyo, Japan (Y.I.).
authors.forename: Shinichi
authors.initials: S
authors.lastname: Oikawa
authors.affiliation: From the Clinical Research Center for Medicine, International University of Health and Welfare, Tokyo, Japan (S.U.); Clinical Trial Department, Cancer Institute Hospital, Tokyo, Japan (N.I.); Department of Cardiology, Shin-Oyama City Hospital, Tochigi, Japan (K.S.); Teikyo Academic Research Center, Teikyo University, Tokyo, Japan (T.T.); Clinical Research Support Center, Center for Epidemiology and Preventive Medicine, The University of Tokyo Hospital, Tokyo, Japan (T.Y.); Diabetes and Life Style Disease Center, Fukujyuji Hospital, Tokyo, Japan (S.O.); Japan Physician's Association, Tokyo, Japan (M.S.); Department of Internal Medicine, Kitamura Memorial Clinic, Tokyo, Japan (K.A.); Department of Laboratory Medicine, Keio University School of Medicine, Tokyo, Japan (M. Murata); Department of Hematology/Oncology, Tokai University Hachioji Hospital, Tokyo, Japan (K.Y.); National Cerebral and Cardiovascular Center, Osaka, Japan (K.M.); Department of Clinical Neuroscience and Therapeutics, Hiroshima University, Hiroshima, Japan (M. Matsumoto); and Graduate School of Advanced Science and Engineering, Waseda University, Tokyo, Japan (Y.I.).
authors.forename: Masahiro
authors.initials: M
authors.lastname: Sugawara
authors.affiliation: From the Clinical Research Center for Medicine, International University of Health and Welfare, Tokyo, Japan (S.U.); Clinical Trial Department, Cancer Institute Hospital, Tokyo, Japan (N.I.); Department of Cardiology, Shin-Oyama City Hospital, Tochigi, Japan (K.S.); Teikyo Academic Research Center, Teikyo University, Tokyo, Japan (T.T.); Clinical Research Support Center, Center for Epidemiology and Preventive Medicine, The University of Tokyo Hospital, Tokyo, Japan (T.Y.); Diabetes and Life Style Disease Center, Fukujyuji Hospital, Tokyo, Japan (S.O.); Japan Physician's Association, Tokyo, Japan (M.S.); Department of Internal Medicine, Kitamura Memorial Clinic, Tokyo, Japan (K.A.); Department of Laboratory Medicine, Keio University School of Medicine, Tokyo, Japan (M. Murata); Department of Hematology/Oncology, Tokai University Hachioji Hospital, Tokyo, Japan (K.Y.); National Cerebral and Cardiovascular Center, Osaka, Japan (K.M.); Department of Clinical Neuroscience and Therapeutics, Hiroshima University, Hiroshima, Japan (M. Matsumoto); and Graduate School of Advanced Science and Engineering, Waseda University, Tokyo, Japan (Y.I.).
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Ando
authors.affiliation: From the Clinical Research Center for Medicine, International University of Health and Welfare, Tokyo, Japan (S.U.); Clinical Trial Department, Cancer Institute Hospital, Tokyo, Japan (N.I.); Department of Cardiology, Shin-Oyama City Hospital, Tochigi, Japan (K.S.); Teikyo Academic Research Center, Teikyo University, Tokyo, Japan (T.T.); Clinical Research Support Center, Center for Epidemiology and Preventive Medicine, The University of Tokyo Hospital, Tokyo, Japan (T.Y.); Diabetes and Life Style Disease Center, Fukujyuji Hospital, Tokyo, Japan (S.O.); Japan Physician's Association, Tokyo, Japan (M.S.); Department of Internal Medicine, Kitamura Memorial Clinic, Tokyo, Japan (K.A.); Department of Laboratory Medicine, Keio University School of Medicine, Tokyo, Japan (M. Murata); Department of Hematology/Oncology, Tokai University Hachioji Hospital, Tokyo, Japan (K.Y.); National Cerebral and Cardiovascular Center, Osaka, Japan (K.M.); Department of Clinical Neuroscience and Therapeutics, Hiroshima University, Hiroshima, Japan (M. Matsumoto); and Graduate School of Advanced Science and Engineering, Waseda University, Tokyo, Japan (Y.I.).
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Murata
authors.affiliation: From the Clinical Research Center for Medicine, International University of Health and Welfare, Tokyo, Japan (S.U.); Clinical Trial Department, Cancer Institute Hospital, Tokyo, Japan (N.I.); Department of Cardiology, Shin-Oyama City Hospital, Tochigi, Japan (K.S.); Teikyo Academic Research Center, Teikyo University, Tokyo, Japan (T.T.); Clinical Research Support Center, Center for Epidemiology and Preventive Medicine, The University of Tokyo Hospital, Tokyo, Japan (T.Y.); Diabetes and Life Style Disease Center, Fukujyuji Hospital, Tokyo, Japan (S.O.); Japan Physician's Association, Tokyo, Japan (M.S.); Department of Internal Medicine, Kitamura Memorial Clinic, Tokyo, Japan (K.A.); Department of Laboratory Medicine, Keio University School of Medicine, Tokyo, Japan (M. Murata); Department of Hematology/Oncology, Tokai University Hachioji Hospital, Tokyo, Japan (K.Y.); National Cerebral and Cardiovascular Center, Osaka, Japan (K.M.); Department of Clinical Neuroscience and Therapeutics, Hiroshima University, Hiroshima, Japan (M. Matsumoto); and Graduate School of Advanced Science and Engineering, Waseda University, Tokyo, Japan (Y.I.).
authors.forename: Kenji
authors.initials: K
authors.lastname: Yokoyama
authors.affiliation: From the Clinical Research Center for Medicine, International University of Health and Welfare, Tokyo, Japan (S.U.); Clinical Trial Department, Cancer Institute Hospital, Tokyo, Japan (N.I.); Department of Cardiology, Shin-Oyama City Hospital, Tochigi, Japan (K.S.); Teikyo Academic Research Center, Teikyo University, Tokyo, Japan (T.T.); Clinical Research Support Center, Center for Epidemiology and Preventive Medicine, The University of Tokyo Hospital, Tokyo, Japan (T.Y.); Diabetes and Life Style Disease Center, Fukujyuji Hospital, Tokyo, Japan (S.O.); Japan Physician's Association, Tokyo, Japan (M.S.); Department of Internal Medicine, Kitamura Memorial Clinic, Tokyo, Japan (K.A.); Department of Laboratory Medicine, Keio University School of Medicine, Tokyo, Japan (M. Murata); Department of Hematology/Oncology, Tokai University Hachioji Hospital, Tokyo, Japan (K.Y.); National Cerebral and Cardiovascular Center, Osaka, Japan (K.M.); Department of Clinical Neuroscience and Therapeutics, Hiroshima University, Hiroshima, Japan (M. Matsumoto); and Graduate School of Advanced Science and Engineering, Waseda University, Tokyo, Japan (Y.I.).
authors.forename: Kazuo
authors.initials: K
authors.lastname: Minematsu
authors.affiliation: From the Clinical Research Center for Medicine, International University of Health and Welfare, Tokyo, Japan (S.U.); Clinical Trial Department, Cancer Institute Hospital, Tokyo, Japan (N.I.); Department of Cardiology, Shin-Oyama City Hospital, Tochigi, Japan (K.S.); Teikyo Academic Research Center, Teikyo University, Tokyo, Japan (T.T.); Clinical Research Support Center, Center for Epidemiology and Preventive Medicine, The University of Tokyo Hospital, Tokyo, Japan (T.Y.); Diabetes and Life Style Disease Center, Fukujyuji Hospital, Tokyo, Japan (S.O.); Japan Physician's Association, Tokyo, Japan (M.S.); Department of Internal Medicine, Kitamura Memorial Clinic, Tokyo, Japan (K.A.); Department of Laboratory Medicine, Keio University School of Medicine, Tokyo, Japan (M. Murata); Department of Hematology/Oncology, Tokai University Hachioji Hospital, Tokyo, Japan (K.Y.); National Cerebral and Cardiovascular Center, Osaka, Japan (K.M.); Department of Clinical Neuroscience and Therapeutics, Hiroshima University, Hiroshima, Japan (M. Matsumoto); and Graduate School of Advanced Science and Engineering, Waseda University, Tokyo, Japan (Y.I.).
authors.forename: Masayasu
authors.initials: M
authors.lastname: Matsumoto
authors.affiliation: From the Clinical Research Center for Medicine, International University of Health and Welfare, Tokyo, Japan (S.U.); Clinical Trial Department, Cancer Institute Hospital, Tokyo, Japan (N.I.); Department of Cardiology, Shin-Oyama City Hospital, Tochigi, Japan (K.S.); Teikyo Academic Research Center, Teikyo University, Tokyo, Japan (T.T.); Clinical Research Support Center, Center for Epidemiology and Preventive Medicine, The University of Tokyo Hospital, Tokyo, Japan (T.Y.); Diabetes and Life Style Disease Center, Fukujyuji Hospital, Tokyo, Japan (S.O.); Japan Physician's Association, Tokyo, Japan (M.S.); Department of Internal Medicine, Kitamura Memorial Clinic, Tokyo, Japan (K.A.); Department of Laboratory Medicine, Keio University School of Medicine, Tokyo, Japan (M. Murata); Department of Hematology/Oncology, Tokai University Hachioji Hospital, Tokyo, Japan (K.Y.); National Cerebral and Cardiovascular Center, Osaka, Japan (K.M.); Department of Clinical Neuroscience and Therapeutics, Hiroshima University, Hiroshima, Japan (M. Matsumoto); and Graduate School of Advanced Science and Engineering, Waseda University, Tokyo, Japan (Y.I.).
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ikeda
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000009:adverse effects / Q000627:therapeutic use*; D002545:Brain Ischemia / Q000453:epidemiology / Q000517:prevention & control*; D015897:Comorbidity; D003920:Diabetes Mellitus / Q000453:epidemiology; D050171:Dyslipidemias / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000453:epidemiology; D020300:Intracranial Hemorrhages / Q000139:chemically induced / Q000453:epidemiology*; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data*; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011322:Primary Prevention / Q000706:statistics & numerical data*; D012307:Risk Factors; D020521:Stroke / Q000453:epidemiology / Q000517:prevention & control*
chemical_list: D010975:Platelet Aggregation Inhibitors; D001241:Aspirin
keywords: aspirin; diabetes mellitus; intracranial hemorrhage; risk factor; stroke prevention