Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial - Full Text View

Sponsored by:	Kumamoto University
Information provided by:	Kumamoto University
ClinicalTrials.gov Identifier:	NCT00110448

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 IV

MedlinePlus related topics: Coronary Artery Disease Diabetes

Drug Information available for: Acetylsalicylic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Japanese Primary Prevention of Atherosclerosis With Aspirin for Diabetes (JPAD) Trial

Further study details as provided by Kumamoto University:

Primary Outcome Measures:

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 ]

Enrollment:	2539
Study Start Date:	December 2002
Study Completion Date:	July 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Aspirin use	Drug: Aspirin Aspirin 81 mg or 100 mg per day
2: Active Comparator 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

Ages Eligible for Study:	30 Years to 85 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110448

Locations

Japan
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Kumamoto, Japan, 860-8556
Japan, Nara
First Department of Internal Medicine, Nara Medical University
Kashihara, Nara, Japan, 634-8522

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 indexed to this study:

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. Epub 2008 Nov 9.

Responsible Party:	Kumamoto University ( Hisao Ogawa )
Study ID Numbers:	H14-Kouka(Seikatsu)-025
Study First Received:	May 9, 2005
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00110448
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kumamoto University:

type 2 diabetes
coronary heart diseases
primary prevention
atherosclerosis
aspirin

Study placed in the following topic categories:

Atherosclerosis
Arterial Occlusive Diseases
Heart Diseases
Metabolic Diseases
Myocardial Ischemia
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Arteriosclerosis

Ischemia
Coronary Disease
Aspirin
Diabetes Mellitus, Type 2
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Coronary Artery Disease

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009