NCT00110448

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,539

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2002

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

November 2, 2016

Status Verified

August 1, 2008

Enrollment Period

5.3 years

First QC Date

May 9, 2005

Last Update Submit

October 31, 2016

Conditions

Coronary DiseaseArteriosclerosisDiabetes Mellitus, Type 2

Keywords

type 2 diabetescoronary heart diseasesprimary preventionatherosclerosisaspirin

Outcome Measures

Primary Outcomes (3)

  • 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)

Study Arms (2)

1

ACTIVE COMPARATOR

Aspirin use

Drug: Aspirin

2

ACTIVE COMPARATOR

No aspirin use

Drug: No aspirin

Interventions

AspirinDRUG

Aspirin 81 mg or 100 mg per day

1
No aspirinDRUG

No aspirin use

2

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients have type 2 diabetes mellitus (30 or more years old and 85 years old or less).
  • Patients give their informed consent to participate.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Kumamoto, Kumamoto, 860-8556, Japan

Location

First Department of Internal Medicine, Nara Medical University

Kashihara, Nara, 634-8522, Japan

Location

Related Publications (7)

  • 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.

    PMID: 35361621DERIVED

  • 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.

    PMID: 35224730DERIVED

  • 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.

    PMID: 31801787DERIVED

  • 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.

    PMID: 27881565DERIVED

  • 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.

    PMID: 21515838DERIVED

  • 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.

    PMID: 21270185DERIVED

  • 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.

    PMID: 18997198DERIVED

MeSH Terms

Conditions

Coronary DiseaseArteriosclerosisDiabetes Mellitus, Type 2Atherosclerosis

Interventions

AspirinN-acetyl-S-(alpha-methyl-4-(2-methylpropyl)benzeneacetyl)cysteine 4-(nitrooxy)butyl ester

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArterial Occlusive DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Hisao Ogawa, MD

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

    PRINCIPAL INVESTIGATOR

  • Yoshihiko Saito, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2005

First Posted

May 10, 2005

Study Start

December 1, 2002

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

November 2, 2016

Record last verified: 2008-08

Locations

JP(2)