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

This study has been completed.
Sponsor:
Information provided by:
Kumamoto University
ClinicalTrials.gov Identifier:
NCT00110448
First received: May 9, 2005
Last updated: September 22, 2008
Last verified: August 2008

May 9, 2005
September 22, 2008
December 2002
May 2008   (final data collection date for primary outcome measure)
  • Cardiovascular events [ Time Frame: five years (median) ] [ Designated as safety issue: No ]
  • Cerebral vascular events [ Time Frame: five years (median) ] [ Designated as safety issue: No ]
  • Aortic and peripheral vascular events, which needs internal medicine and/or surgical medical treatment [ Time Frame: five years (median) ] [ Designated as safety issue: No ]
  • cardiovascular events
  • cerebral vascular disease
Complete list of historical versions of study NCT00110448 on ClinicalTrials.gov Archive Site
Not Provided
other arteriosclerotic disease, which needs internal medicine and/or surgical medical treatment
Not Provided
Not Provided
 
Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial
Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Coronary Disease
  • Arteriosclerosis
  • Diabetes Mellitus, Type 2
  • Drug: Aspirin
    Aspirin 81 mg or 100 mg per day
  • Drug: No aspirin
    No aspirin use
  • Active Comparator: 1
    Aspirin use
    Intervention: Drug: Aspirin
  • Active Comparator: 2
    No aspirin use
    Intervention: Drug: No aspirin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2539
July 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
30 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00110448
H14-Kouka(Seikatsu)-025
Yes
Hisao Ogawa, Kumamoto University
Kumamoto University
Not Provided
Principal Investigator: 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
Kumamoto University
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP