Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
NCT ID: NCT03248401
Last Updated: 2020-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2016-09-26
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cilostazol group
Cilostazol 200 mg or maximal tolerate dose
Cilostazol
Cilostazol 200 mg/day
Aspirin group
Aspirin 100 mg
Aspirin
Aspirin 100 mg/day
Interventions
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Cilostazol
Cilostazol 200 mg/day
Aspirin
Aspirin 100 mg/day
Eligibility Criteria
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Inclusion Criteria
* Patients with type 2 diabetes on treatment (HbA1c 6.0-11.0%)
* Carotid plaque on 3D ultrasound
Exclusion Criteria
* Diagnosed with heart failure
* Suggestive of ischemia on ECG
* Uncontrolled hypertension
* Recently diagnosed with peptic ulcer disease
* Taking other antiplatelet agents
* Hypersensitivity to salicylic acid
* Aspirin induced asthma
* Severe kidney, liver, heart disease
30 Years
80 Years
ALL
No
Sponsors
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Seoul National University Bundang Hospital
OTHER
Responsible Party
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Soo Lim
Professor
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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References
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Katakami N, Kim YS, Kawamori R, Yamasaki Y. The phosphodiesterase inhibitor cilostazol induces regression of carotid atherosclerosis in subjects with type 2 diabetes mellitus: principal results of the Diabetic Atherosclerosis Prevention by Cilostazol (DAPC) study: a randomized trial. Circulation. 2010 Jun 15;121(23):2584-91. doi: 10.1161/CIRCULATIONAHA.109.892414. Epub 2010 Jun 1.
Huh JH, Seok H, Lee BW, Kang ES, Lee HC, Cha BS. Effect of cilostazol on carotid intima-media thickness in type 2 diabetic patients without cardiovascular event. Endocrine. 2014 Sep;47(1):138-45. doi: 10.1007/s12020-013-0120-y. Epub 2014 Jan 1.
Lee DH, Chun EJ, Moon JH, Yun HM, Lim S. Effect of cilostazol on carotid plaque volume measured by three-dimensional ultrasonography in patients with type 2 diabetes: The FANCY study. Diabetes Obes Metab. 2020 Dec;22(12):2257-2266. doi: 10.1111/dom.14147. Epub 2020 Sep 17.
Other Identifiers
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Cilostazol_Carotid a. plaque
Identifier Type: -
Identifier Source: org_study_id
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