UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000215 |
|---|---|
| Receipt number | R000000252 |
| Scientific Title | Study on Therapeutic Effects of Antiplatelet Drugs in Prevention of Occurrence and Inhibition of Progression of Diabetic Atherosclerosis |
| Date of disclosure of the study information | 2005/10/01 |
| Last modified on | 2010/06/23 16:30:53 |
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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
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
Sponsor or person
Institute
DAPC Study Steering Committee
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000252
