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

Completed

Phase 4 Results

Trial Description

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

Interventions

  • Aspirin (stroke prevention) Drug
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
  • Aspirin Drug
    Intervention Desc: Aspirin 81 mg or 100 mg per day
    ARM 1: Kind: Experimental
    Label: 1
    Description: Aspirin use
  • No aspirin Drug
    Intervention Desc: No aspirin use
    ARM 1: Kind: Experimental
    Label: 2
    Description: No aspirin use

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients were randomized to one of two arms. The active arm received ASA and the inactive arm a placebo. Follow-up for 5 years after enrollment.

Outcomes

Type Measure Time Frame Safety Issue
Primary Cardiovascular events; cerebral vascular events; aortic and peripheral vascular events, which needs internal medicine and/or surgical medical treatment.
Primary Cardiovascular events five years (median) No
Primary Cerebral vascular events five years (median) No
Primary Aortic and peripheral vascular events, which needs internal medicine and/or surgical medical treatment five years (median) No

Sponsors