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

Phase 4

Completed

• Conditions: Arteriosclerosis; Coronary Disease; Diabetes Mellitus, Type 2
• Interventions: Drug: No aspirin; Drug: Aspirin

• Registration Number: NCT00110448
• Lead Sponsor: Kumamoto University

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 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 Timeline

• Study Start: 2002-12
• Study First Submitted: 2005-05-09
• Study First Submitted QC: 2005-05-09
• Study First Posted: 2005-05-10
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2008-08
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2539

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	No aspirin	No aspirin use
1	Aspirin	Aspirin use

Primary Outcome Measures

Name	Time	Method
Cardiovascular events	five years (median)
Aortic and peripheral vascular events, which needs internal medicine and/or surgical medical treatment	five years (median)
Cerebral vascular events	five years (median)

Trial Locations

Locations (2)

First Department of Internal Medicine, Nara Medical University; 🇯🇵 Kashihara, Nara, Japan

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University; 🇯🇵 Kumamoto, Japan