Trial | NCT00110448  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    2539
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.
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 Started
Dec 31
2002
Primary Completion
Apr 30
2008
Study Completion
Apr 30
2008
Last Update
Nov 02
2016
Estimate

Drug Aspirin

Aspirin 81 mg or 100 mg per day

Drug No aspirin

No aspirin use

1 Active Comparator

Aspirin use

2 Active Comparator

No aspirin use

Criteria 

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.
No Results Posted