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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000215 |
Receipt No. | 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 |
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) |
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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) |
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Region |
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Condition | ||
Condition | Diabetes | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Aspirin group (81-100mg/day)
2 years |
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Interventions/Control_2 | Cilostazol group (100-200,g/day)
2 years |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 400 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | DAPC Study Steering Committee |
Institute | |
Department |
Funding Source | |
Organization | Japan Cardiovascular Research Foundation |
Organization | |
Division | |
Category of Funding Organization | Non profit foundation |
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IRB Contact (For public release) | |
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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 |
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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 | |
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Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |