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

Condition(s) targeted: Coronary Disease; Arteriosclerosis; Diabetes Mellitus, Type 2

Intervention: Aspirin (Drug); No aspirin (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Kumamoto University

Official(s) and/or principal investigator(s):
Hisao Ogawa, MD, Principal Investigator, Affiliation: Professor of Medicine, Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Yoshihiko Saito, MD, Principal Investigator, Affiliation: Professor of Medicine, First Department of Internal Medicine, Nara Medical University

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.

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

Study design: Prevention, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

cardiovascular events

cerebral vascular disease

Secondary outcome: other arteriosclerotic disease, which needs internal medicine and/or surgical medical treatment

Detailed description: 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.

Minimum age: 30 Years. Maximum age: 85 Years. Gender(s): 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.

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

First Department of Internal Medicine, Nara Medical University, Kashihara, Nara 634-8522, Japan

Starting date: December 2002
Ending date: December 2008
Last updated: June 2, 2008