NCT00110448

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,539 (actual)
• Sponsor: Kumamoto University · Academic / Other
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Disease
• Arteriosclerosis
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Aspirin	Aspirin 81 mg or 100 mg per day
DRUG	No aspirin	No aspirin use

Timeline

• Start date: 2002-12-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2005-05-10
• Last updated: 2016-11-02

Locations

2 sites across 1 country: Japan