Status:

COMPLETED

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

Lead Sponsor:

Kumamoto University

Conditions:

Coronary Disease

Arteriosclerosis

Eligibility:

All Genders

30-85 years

Phase:

PHASE4

Brief 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.

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 throm...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

December 1 2002

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2008

Estimated Enrollment :

2539 Patients enrolled

Trial Details

Trial ID

NCT00110448

Start Date

December 1 2002

End Date

April 1 2008

Last Update

November 2 2016

Active Locations (2)

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Page 1 of 1 (2 locations)

1

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

Kumamoto, Kumamoto, Japan, 860-8556

2

First Department of Internal Medicine, Nara Medical University

Kashihara, Nara, Japan, 634-8522