Back to resultsJapanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial
Primary Purpose
Coronary Disease, Arteriosclerosis, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Aspirin
No aspirin
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Disease focused on measuring type 2 diabetes, coronary heart diseases, primary prevention, atherosclerosis, aspirin
Eligibility 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.
Sites / Locations
- First Department of Internal Medicine, Nara Medical University
- Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Aspirin use
No aspirin use
Outcomes
Primary Outcome Measures
Cardiovascular events
Cerebral vascular events
Aortic and peripheral vascular events, which needs internal medicine and/or surgical medical treatment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00110448
Brief Title
Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial
Official Title
Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kumamoto University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Arteriosclerosis, Diabetes Mellitus, Type 2
Keywords
type 2 diabetes, coronary heart diseases, primary prevention, atherosclerosis, aspirin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2539 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Aspirin use
Arm Title
2
Arm Type
Active Comparator
Arm Description
No aspirin use
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Aspirin 81 mg or 100 mg per day
Intervention Type
Drug
Intervention Name(s)
No aspirin
Intervention Description
No aspirin use
Primary Outcome Measure Information:
Title
Cardiovascular events
Time Frame
five years (median)
Title
Cerebral vascular events
Time Frame
five years (median)
Title
Aortic and peripheral vascular events, which needs internal medicine and/or surgical medical treatment
Time Frame
five years (median)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisao Ogawa, MD
Organizational Affiliation
Professor of Medicine, Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yoshihiko Saito, MD
Organizational Affiliation
Professor of Medicine, First Department of Internal Medicine, Nara Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Department of Internal Medicine, Nara Medical University
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
35361621
Citation
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.
Results Reference
derived
PubMed Identifier
35224730
Citation
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.
Results Reference
derived
PubMed Identifier
31801787
Citation
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.
Results Reference
derived
PubMed Identifier
27881565
Citation
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.
Results Reference
derived
PubMed Identifier
21515838
Citation
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.
Results Reference
derived
PubMed Identifier
21270185
Citation
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.
Results Reference
derived
PubMed Identifier
18997198
Citation
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. Erratum In: JAMA. 2009 May 13;301(18):1882. JAMA. 2012 Nov 14;308(18):1861.
Results Reference
derived
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Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial
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