The purpose of this study is to determine the effects of low-dose aspirin for the primary prevention of vascular events in patients with type 2 diabetes in Japan.

Condition	Treatment or Intervention	Phase
Coronary Disease Arteriosclerosis Diabetes Mellitus, Type 2	Drug: Aspirin	Phase IV

Further Study Details: 

Primary Outcomes: cardiovascular events; cerebral vascular disease
Secondary Outcomes: other arteriosclerotic disease, which needs internal medicine and/or surgical medical treatment
Expected Total Enrollment:  2450

There is a worldwide epidemic of diabetes and the number of individuals with diabetes is set to increase further. As individuals with diabetes are at high risk of accelerated atherosclerosis and thrombotic vascular events, the significant proportion of the cardiovascular disease burden is projected to be among this population. JPAD is a multicenter study with a prospective randomized open, blinded end-point (PROBE) design. The doses administered are aspirin 81 mg/day or 100 mg/day, the latter being enteric-coated Aspirin. The primary objective was to compare the effect of aspirin on: 1) cardiovascular events, such as cardiovascular death (including sudden death), myocardial infarction, angina pectoris, silent myocardial infarction; 2) cerebral vascular disease, including cerebral infarction, hemorrhage, and transient ischemic attack; 3) other arteriosclerotic disease, which needs internal medicine and/or surgical medical treatment. Cardiac death was defined as death directly or indirectly related to myocardial infarction or ischemic heart disease. Ischemic stroke was diagnosed based on the presence of neurologic deficit confirmed by computed tomography.

Ages Eligible for Study:  30 Years   -   85 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients have type 2 diabetes mellitus (30 or more years old and 85 years old or less).
• Patients give their informed consent to participate.

Exclusion Criteria:

• Patient has electrocardiographic changes, including ischemic ST-segment depression, ST-segment elevation, or pathologic Q waves.
• Patient has fixed ischemic heart disease, utilizing coronary angiography.
• Patient has cerebral vascular disease, including cerebral infarction, past hemorrhage, and experience of transient ischemic attack.
• Patient has arteriosclerotic disease, which needs internal medicine and/or surgical medical treatment.
• Patient has already taken the following anti-platelet or anti-thrombotic medicine: aspirin, ticlopidine, cilostazol, dipyridamole, trapidil, warfarin, and argatroban.
• Patient has severe gastric and/or duodenal ulcer.
• Patient has severe liver dysfunction.
• Patient has severe renal dysfunction.
• Patient has allergy for aspirin.
• Patient has atrial fibrillation.
• Pregnancy or the possible case of pregnancy.

Please refer to this study by ClinicalTrials.gov identifier  NCT00110448

Hisao Ogawa, MD      +81-96-373-5174    ogawah@kumamoto-u.ac.jp
Masafumi Nakayama, MD      +81-96-373-5175    nakama@kumamoto-u.ac.jp

Japan
      Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto,  860-8556,  Japan; Recruiting

Study chairs or principal investigators

Hisao Ogawa, MD,  Principal Investigator,  Professor of Medicine, Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University   

Study ID Numbers:  H14-Kouka(Seikatsu)-025
Record last reviewed:  May 2005
Last Updated:  May 16, 2005
Record first received:  May 9, 2005
ClinicalTrials.gov Identifier:  NCT00110448
Health Authority: Japan: Pharmaceutical and Medical Safety Bureau - Ministry of Health, Labor, and Welfare (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-05-17