Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial
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| ClinicalTrials.gov Identifier: NCT00110448 |
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Recruitment Status :
Completed
First Posted : May 10, 2005
Last Update Posted : November 2, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Coronary Disease Arteriosclerosis Diabetes Mellitus, Type 2 | Drug: Aspirin Drug: No aspirin | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2539 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial |
| Study Start Date : | December 2002 |
| Actual Primary Completion Date : | April 2008 |
| Actual Study Completion Date : | April 2008 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
Aspirin use
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Drug: Aspirin
Aspirin 81 mg or 100 mg per day |
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Active Comparator: 2
No aspirin use
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Drug: No aspirin
No aspirin use |
- 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) ]
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| Ages Eligible for Study: | 30 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00110448
| Japan | |
| First Department of Internal Medicine, Nara Medical University | |
| Kashihara, Nara, Japan, 634-8522 | |
| Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University | |
| Kumamoto, Japan, 860-8556 | |
| 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 |
| Responsible Party: | Kumamoto University |
| ClinicalTrials.gov Identifier: | NCT00110448 |
| Other Study ID Numbers: |
H14-Kouka(Seikatsu)-025 |
| First Posted: | May 10, 2005 Key Record Dates |
| Last Update Posted: | November 2, 2016 |
| Last Verified: | August 2008 |
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type 2 diabetes coronary heart diseases primary prevention atherosclerosis aspirin |
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Atherosclerosis Coronary Disease Arteriosclerosis Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Myocardial Ischemia Heart Diseases Aspirin Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |