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

NCT ID: NCT00110448

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2539 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2008-04-30

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.

Conditions

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Coronary Disease Arteriosclerosis Diabetes Mellitus, Type 2

Keywords

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type 2 diabetes coronary heart diseases primary prevention atherosclerosis aspirin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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1

Aspirin use

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

Aspirin 81 mg or 100 mg per day

2

No aspirin use

Group Type ACTIVE_COMPARATOR

No aspirin

Intervention Type DRUG

No aspirin use

Interventions

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Aspirin

Aspirin 81 mg or 100 mg per day

Intervention Type DRUG

No aspirin

No aspirin use

Intervention Type DRUG

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kumamoto University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hisao Ogawa, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine, Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University

Yoshihiko Saito, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine, First Department of Internal Medicine, Nara Medical University

Locations

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Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University

Kumamoto, Kumamoto, Japan

Site Status

First Department of Internal Medicine, Nara Medical University

Kashihara, Nara, Japan

Site Status

Countries

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Japan

References

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Matsumoto C, Ogawa H, Saito Y, Okada S, Soejima H, Sakuma M, Masuda I, Nakayama M, Doi N, Jinnouchi H, Waki M, Morimoto T. Incidence of atrial fibrillation in elderly patients with type 2 diabetes mellitus. BMJ Open Diabetes Res Care. 2022 Mar;10(2):e002745. doi: 10.1136/bmjdrc-2021-002745.

Reference Type DERIVED
PMID: 35361621 (View on PubMed)

Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

Reference Type DERIVED
PMID: 35224730 (View on PubMed)

Matsumoto C, Ogawa H, Saito Y, Okada S, Soejima H, Sakuma M, Masuda I, Nakayama M, Doi N, Jinnouchi H, Waki M, Morimoto T; JPAD Trial Investigators; JPAD Trial Investigators:. Sex Difference in Effects of Low-Dose Aspirin on Prevention of Dementia in Patients With Type 2 Diabetes: A Long-term Follow-up Study of a Randomized Clinical Trial. Diabetes Care. 2020 Feb;43(2):314-320. doi: 10.2337/dc19-1188. Epub 2019 Dec 4.

Reference Type DERIVED
PMID: 31801787 (View on PubMed)

Saito Y, Okada S, Ogawa H, Soejima H, Sakuma M, Nakayama M, Doi N, Jinnouchi H, Waki M, Masuda I, Morimoto T; JPAD Trial Investigators. Low-Dose Aspirin for Primary Prevention of Cardiovascular Events in Patients With Type 2 Diabetes Mellitus: 10-Year Follow-Up of a Randomized Controlled Trial. Circulation. 2017 Feb 14;135(7):659-670. doi: 10.1161/CIRCULATIONAHA.116.025760. Epub 2016 Nov 15.

Reference Type DERIVED
PMID: 27881565 (View on PubMed)

Okada S, Morimoto T, Ogawa H, Kanauchi M, Nakayama M, Uemura S, Doi N, Jinnouchi H, Waki M, Soejima H, Sakuma M, Saito Y; Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes Trial Investigators. Differential effect of low-dose aspirin for primary prevention of atherosclerotic events in diabetes management: a subanalysis of the JPAD trial. Diabetes Care. 2011 Jun;34(6):1277-83. doi: 10.2337/dc10-2451. Epub 2011 Apr 22.

Reference Type DERIVED
PMID: 21515838 (View on PubMed)

Saito Y, Morimoto T, Ogawa H, Nakayama M, Uemura S, Doi N, Jinnouchi H, Waki M, Soejima H, Sugiyama S, Okada S, Akai Y; Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes Trial Investigators. Low-dose aspirin therapy in patients with type 2 diabetes and reduced glomerular filtration rate: subanalysis from the JPAD trial. Diabetes Care. 2011 Feb;34(2):280-5. doi: 10.2337/dc10-1615.

Reference Type DERIVED
PMID: 21270185 (View on PubMed)

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. Low-dose aspirin for primary prevention of atherosclerotic events in patients with type 2 diabetes: a randomized controlled trial. JAMA. 2008 Nov 12;300(18):2134-41. doi: 10.1001/jama.2008.623. Epub 2008 Nov 9.

Reference Type DERIVED
PMID: 18997198 (View on PubMed)

Other Identifiers

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H14-Kouka(Seikatsu)-025

Identifier Type: -

Identifier Source: org_study_id