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

October 31, 2016 updated by: Kumamoto 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.

Study Overview

Status

Completed

Conditions

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

We also analyze hemorrhagic events in this RCT.

Study Type

Interventional

Enrollment (Actual)

2539

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kumamoto, Japan, 860-8556
        • Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
    • Nara
      • Kashihara, Nara, Japan, 634-8522
        • First Department of Internal Medicine, Nara Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Aspirin use
Drug: Aspirin
Aspirin 81 mg or 100 mg per day
Active Comparator: 2
No aspirin use
Drug: No aspirin
No aspirin use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular events
Time Frame: five years (median)
five years (median)
Cerebral vascular events
Time Frame: five years (median)
five years (median)
Aortic and peripheral vascular events, which needs internal medicine and/or surgical medical treatment
Time Frame: five years (median)
five years (median)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kumamoto University

Investigators

  • Principal Investigator: Hisao Ogawa, MD, Professor of Medicine, Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
  • Principal Investigator: Yoshihiko Saito, MD, Professor of Medicine, First Department of Internal Medicine, Nara Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

May 9, 2005

First Submitted That Met QC Criteria

May 9, 2005

First Posted (Estimate)

May 10, 2005

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H14-Kouka(Seikatsu)-025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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