Clinical trial NCT00110448: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Disease
Arteriosclerosis
Diabetes Mellitus, Type 2
Keywords: type 2 diabetes
coronary heart diseases
primary prevention
atherosclerosis
aspirin
Lead sponsor: Kumamoto University
Sponsor class: OTHER
First posted: 2005-05-10
Enrollment: 2539
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Cardiovascular events
timeFrame: five years (median)
measure: Cerebral vascular events
timeFrame: five years (median)
measure: Aortic and peripheral vascular events, which needs internal medicine and/or surgical medical treatment
timeFrame: five years (median)
Secondary outcomes:
Other outcomes:
Locations:
city: Kashihara
country: Japan
facility: First Department of Internal Medicine, Nara Medical University
state: Nara
city: Kumamoto
country: Japan
facility: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Study officials:
affiliation: Professor of Medicine, Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
name: Hisao Ogawa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Medicine, First Department of Internal Medicine, Nara Medical University
name: Yoshihiko Saito, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.