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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Disease, Arteriosclerosis, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Aspirin
* Drug: No aspirin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Aspirin use | Drug: Aspirin<br>* Aspirin 81 mg or 100 mg per day<br>|
| Active Comparator: 2<br>No aspirin use | Drug: No aspirin<br>* No aspirin use<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes, coronary heart diseases, primary prevention, atherosclerosis, aspirin