UMIN-CTR Clinical Trial

Basic information
Public title	Study on Therapeutic Effects of Antiplatelet Drugs in Prevention of Occurrence and Inhibition of Progression of Diabetic Atherosclerosis
Acronym	Study of Diabetic Atherosclerosis Prevention by Cilostazol (DAPC Study)
Scientific Title	Study on Therapeutic Effects of Antiplatelet Drugs in Prevention of Occurrence and Inhibition of Progression of Diabetic Atherosclerosis
Scientific Title:Acronym	Study of Diabetic Atherosclerosis Prevention by Cilostazol (DAPC Study)
Region	Japan Asia(except Japan)

Condition
Condition	Diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is conducted as a large-scale interventional study performed in Asian countries, including Japan and South Korea, to clarify the efficacy and usefulness of antiplatelet drugs in the primary prevention and secondary treatment of diabetic atherosclerosis by chronologically observing the intima-media thickness (IMT) of the carotid artery, which is used as a quantitative index of atherosclerosis and by analyzing the occurrence and progression of large-vessel complications in type 2 diabetic patients with mild atherosclerosis for the purpose of investigating the efficacy of antiplatelet drugs (aspirin and cilostazol) clinically used in a wide range at present.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of maximum and mean intima-media thickness (IMT) in bilateral common carotid artery.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Aspirin group (81-100mg/day) 2 years
Interventions/Control_2	Cilostazol group (100-200,g/day) 2 years
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with type 2 diabetes who are suspected of having arteriosclerosis obliterans (ASO)
Key exclusion criteria	1 Patients with type 1 diabetes or secondary diabetes 2 Patients aged under 40 years old, or over 76 years old 3 Patients with severe ASO rated as Fontaine IIb or over 4 Patients with cerebrovascular disorders rated as Grade 4 or over in Modified Rankin Scale (Severe disorder which needs assistance for personal care and walk) 5 Patients with a medical history of angina or myocardial infarction 6 Patients with severe hepatic dysfunction (liver cirrhosis) or renal dysfunction (serum creatinine 1.5mg/dl) 7 Patients with congestive heart failure 8 Patients with bleeding tendency or bleeding 9 Patients with severe hematological abnormality 10 Patients with definite homologousfamilial hypercholesterolemia 11 Patients who have allergies or a medical history of hypersensitivity to the investigational drugs 12 Pregnant or lactating women, or women who wish to become pregnant 13 Others whom the investigator judges inappropriate as subjects for this study
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshimitsu Yamasaki
Organization	Osaka University Graduate School of Medicine
Division name	Department of Internal Medicine and Therapeutics
Zip code
Address	2-2, Yamadaoka Suita-city Osaka, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Munehide Matsuhisa
Organization	Osaka University Graduate School of Medicine
Division name	Department of Internal Medicine and Therapeutics
Zip code
Address	2-2, Yamadaoka Suita-city Osaka, Japan
TEL
Homepage URL
Email

Sponsor
Institute	DAPC Study Steering Committee
Institute
Department

Funding Source
Organization	Japan Cardiovascular Research Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2005 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2004 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date	2004 Year 12 Month 01 Day
Last follow-up date	2008 Year 06 Month 01 Day
Date of closure to data entry	2008 Year 09 Month 01 Day
Date trial data considered complete	2008 Year 12 Month 01 Day
Date analysis concluded	2009 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date	2005 Year 09 Month 13 Day
Last modified on	2010 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000252

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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