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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00110448
First Posted: May 10, 2005
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kumamoto University
  Purpose
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.

Condition Intervention Phase
Coronary Disease Arteriosclerosis Diabetes Mellitus, Type 2 Drug: Aspirin Drug: No aspirin Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Kumamoto University:

Primary Outcome Measures:
  • 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) ]

Enrollment: 2539
Study Start Date: December 2002
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Aspirin use
Drug: Aspirin
Aspirin 81 mg or 100 mg per day
Active Comparator: 2
No aspirin use
Drug: No aspirin
No aspirin use

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Kumamoto University
Investigators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kumamoto University
ClinicalTrials.gov Identifier: NCT00110448     History of Changes
Other Study ID Numbers: H14-Kouka(Seikatsu)-025
First Submitted: May 9, 2005
First Posted: May 10, 2005
Last Update Posted: November 2, 2016
Last Verified: August 2008

Keywords provided by Kumamoto University:
type 2 diabetes
coronary heart diseases
primary prevention
atherosclerosis
aspirin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Atherosclerosis
Coronary Disease
Coronary Artery Disease
Arteriosclerosis
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