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

Conditions

Coronary Disease, Arteriosclerosis, Diabetes Mellitus, Type 2

Keywords

type 2 diabetes, coronary heart diseases, primary prevention, atherosclerosis, aspirin

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.

Chisa Matsumoto, Hisao Ogawa, Yoshihiko Saito, Sadanori Okada, Hirofumi Soejima et al. (12 authors)

BMJ Open Diabetes Research & Care2022-03-016 citations

10.1136/bmjdrc-2021-002745

Low-Dose Aspirin for Primary Prevention of Cardiovascular Events in Patients With Type 2 Diabetes Mellitus

Yoshihiko Saito, Sadanori Okada, Hisao Ogawa, Hirofumi Soejima, Mio Sakuma et al. (11 authors)

Circulation2016-11-16136 citations

10.1161/circulationaha.116.025760

How many unpublished studies? ClinicalTrials.gov (n = 2614 studies): diabetes | Closed Studies | Interventional Studies | Phase 3, 4 | Search Date: Oct 27, 2014

Ramirez Jorge H

Figshare2014-01-01

10.6084/m9.figshare.1249628.v1

Low-dose aspirin for primary prevention of atherosclerotic events in patients with type 2 diabetes: a randomized controlled trial.

Ogawa H, Nakayama M, Morimoto T, Uemura S, Kanauchi M, Doi N, Jinnouchi H, Sugiyama S, Saito Y, Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial Investigators.

2008-11-09523 citations

10.1001/jama.2008.623

Interventions

DRUGAspirin

Aspirin 81 mg or 100 mg per day

DRUGNo aspirin

No aspirin use

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 85 Years

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	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)

Countries

Japan

Outcome results

None listed