Coronary DiseasePhase 4NCT00110448
Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial
A Phase 4 study testing Aspirin and No aspirin in people with Coronary Disease and Arteriosclerosis, run by Kumamoto University at 2 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Coronary Disease, Arteriosclerosis, Diabetes Mellitus, Type 2
- What is being tested?
- Aspirin and No aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,539 participants
- Where
- 2 sitesJapan
- Study dates
- Dec 2002to Apr 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients have type 2 diabetes mellitus (30 or more years old and 85 years old or less).
- Patients give their informed consent to participate.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
First Department of Internal Medicine, Nara Medical University
Kashihara, Nara, 634-8522
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Kumamoto, Kumamoto, 860-8556
About this study
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.
Read the 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.
- Being tested
- Aspirin, No aspirin
- Keywords
- type 2 diabetes, coronary heart diseases, primary prevention, atherosclerosis, aspirin
- Medical subject headings
- Coronary Disease, Arteriosclerosis, Diabetes Mellitus, Type 2, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Aspirin 81 mg or 100 mg per day
No aspirinDrug
No aspirin use
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Aspirin use Receives: Drug: Aspirin |
| 2 | Active comparator | No aspirin use Receives: Drug: No aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular events
Measured: five years (median)
Cerebral vascular events
Measured: five years (median)
Aortic and peripheral vascular events, which needs internal medicine and/or surgical medical treatment
Measured: five years (median)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2005 (estimated)
- Study startDec 2002
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,539 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kumamoto University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hisao Ogawa, MD, Principal investigator, Professor of Medicine, Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto UniversityYoshihiko Saito, MD, Principal investigator, Professor of Medicine, First Department of Internal Medicine, Nara Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110448
- Sponsor's protocol ID
- H14-Kouka(Seikatsu)-025
- Status last verified
- Aug 2008
- First submitted
- 9 May 2005
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35361621Natale 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.
PubMed 35224730Matsumoto 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.
PubMed 31801787Saito 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.
PubMed 27881565Okada 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.
PubMed 21515838Saito 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.
PubMed 21270185Ogawa 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.
PubMed 18997198
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial
- ClinicalTrials.gov ID
- NCT00110448
- Acronym / sponsor ID
- H14-Kouka(Seikatsu)-025
- Keywords
- type 2 diabetes, coronary heart diseases, primary prevention, atherosclerosis, aspirin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,539 participants (actual)
- Lead sponsor
- Kumamoto UniversityUniversity, hospital or other
- Study start
- Dec 2002
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 10 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: AspirinAspirin use |
| 2 | Active comparator | Drug: No aspirinNo aspirin use |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients have type 2 diabetes mellitus (30 or more years old and 85 years old or less).
- Patients give their informed consent to participate.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAspirin 81 mg or 100 mg per day | Drug | 1 |
| No aspirinNo aspirin use | Drug | 2 |
Primary outcome
Cardiovascular events
Time frame: five years (median)
Cerebral vascular events
Time frame: five years (median)
Aortic and peripheral vascular events, which needs internal medicine and/or surgical medical treatment
Time frame: five years (median)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 35361621Matsumoto 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.
- Derived from this study: PubMed 35224730Natale 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.
- Derived from this study: PubMed 31801787Matsumoto 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.
- Derived from this study: PubMed 27881565Saito 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.
- Derived from this study: PubMed 21515838Okada 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.
- Derived from this study: PubMed 21270185Saito 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.
- Derived from this study: PubMed 18997198Ogawa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hisao Ogawa, MD principal investigator
Professor of Medicine, Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Yoshihiko Saito, MD principal investigator
Professor of Medicine, First Department of Internal Medicine, Nara Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin and No aspirin in people with Coronary Disease and Arteriosclerosis, run by Kumamoto University at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular events (time frame: five years (median)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00110448, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.