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

Last updated: October 31, 2016
Sponsor: Kumamoto University
Overall Status: Completed

Phase

4

Condition

Chest Pain

Hypercholesterolemia

Heart Disease

Treatment

N/A

Clinical Study ID

NCT00110448
H14-Kouka(Seikatsu)-025
  • Ages 30-85
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients have type 2 diabetes mellitus (30 or more years old and 85 years old orless).

  • Patients give their informed consent to participate.

Exclusion

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 surgicalmedical 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.

Study Design

Total Participants: 2539
Study Start date:
December 01, 2002
Estimated Completion Date:
April 30, 2008

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

We also analyze hemorrhagic events in this RCT.

Connect with a study center

  • First Department of Internal Medicine, Nara Medical University

    Kashihara, Nara 634-8522
    Japan

    Site Not Available

  • Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University

    Kumamoto, 860-8556
    Japan

    Site Not Available

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