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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00110448
• Other study ID #: H14-Kouka(Seikatsu)-025
• Status: Completed
• Phase: Phase 4
• First received: May 9, 2005
• Last updated: October 31, 2016
• Start date: December 2002
• Est. completion date: April 2008

Study information

• Verified date: August 2008
• Source: Kumamoto University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2539
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arteriosclerosis
• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Aspirin
Aspirin 81 mg or 100 mg per day
• No aspirin
No aspirin use

Locations

Country	Name	City	State
Japan	First Department of Internal Medicine, Nara Medical University	Kashihara	Nara
Japan	Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University	Kumamoto

Sponsors (1)

Lead Sponsor	Collaborator
Kumamoto University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular events		five years (median)	No
Primary	Cerebral vascular events		five years (median)	No
Primary	Aortic and peripheral vascular events, which needs internal medicine and/or surgical medical treatment		five years (median)	No