Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial

• Cardiovascular events [ Time Frame: five years (median) ] [ Designated as safety issue: No ]
• Cerebral vascular events [ Time Frame: five years (median) ] [ Designated as safety issue: No ]
• Aortic and peripheral vascular events, which needs internal medicine and/or surgical medical treatment [ Time Frame: five years (median) ] [ Designated as safety issue: No ]

• cardiovascular events
• cerebral vascular disease

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.

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 atherosclerotic events including cardiovascular events, cerebral vascular event, and other vascular events.

We also analyze hemorrhagic events in this RCT.

• Coronary Disease
• Arteriosclerosis
• Diabetes Mellitus, Type 2

• Drug: Aspirin
  Aspirin 81 mg or 100 mg per day
• Drug: No aspirin
  No aspirin use

• Active Comparator: 1
  Aspirin use
  Intervention: Drug: Aspirin
• Active Comparator: 2
  No aspirin use
  Intervention: Drug: No aspirin

• Okada S, Morimoto T, Ogawa H, Kanauchi M, Nakayama M, Uemura S, Doi N, Jinnouchi H, Waki M, Soejima H, Sakuma M, Saito Y; Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes Trial Investigators. Differential effect of low-dose aspirin for primary prevention of atherosclerotic events in diabetes management: a subanalysis of the JPAD trial. Diabetes Care. 2011 Jun;34(6):1277-83. Epub 2011 Apr 22.
• Saito Y, Morimoto T, Ogawa H, Nakayama M, Uemura S, Doi N, Jinnouchi H, Waki M, Soejima H, Sugiyama S, Okada S, Akai Y; Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes Trial Investigators. Low-dose aspirin therapy in patients with type 2 diabetes and reduced glomerular filtration rate: subanalysis from the JPAD trial. Diabetes Care. 2011 Feb;34(2):280-5.
• Ogawa H, Nakayama M, Morimoto T, Uemura S, Kanauchi M, Doi N, Jinnouchi H, Sugiyama S, Saito Y; Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial Investigators. Low-dose aspirin for primary prevention of atherosclerotic events in patients with type 2 diabetes: a randomized controlled trial. JAMA. 2008 Nov 12;300(18):2134-41. Epub 2008 Nov 9.

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.