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Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes Mellitus, Carotid Atherosclerosis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cilostazol
Aspirin
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 30 and 80 years
  • Patients with type 2 diabetes on treatment (HbA1c 6.0-11.0%)
  • Carotid plaque on 3D ultrasound

Exclusion Criteria:

  • Acute bleeding or bleeding tendency
  • 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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cilostazol group

Aspirin group

Arm Description

Cilostazol 200 mg or maximal tolerate dose

Aspirin 100 mg

Outcomes

Primary Outcome Measures

Change of carotid artery atherosclerosis
Plaque composition

Secondary Outcome Measures

Change of carotid artery atherosclerosis 1
Changes in carotid intima-media thickness after treatment
Change of carotid artery atherosclerosis 2
Changes in carotid artery stenosis after treatment
Change of carotid artery atherosclerosis 3
Plaque volume in carotid artery

Full Information

First Posted
August 9, 2017
Last Updated
April 6, 2020
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03248401
Brief Title
Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
Official Title
Effect of Cilostazol, a Phosphodiesterase 3 Inhibitor, on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 26, 2016 (Actual)
Primary Completion Date
October 21, 2018 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To investigate the effect of cilostazol compared with aspirin on carotid atherosclerosis in patients with type 2 diabetes mellitus

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Carotid Atherosclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cilostazol group
Arm Type
Experimental
Arm Description
Cilostazol 200 mg or maximal tolerate dose
Arm Title
Aspirin group
Arm Type
Active Comparator
Arm Description
Aspirin 100 mg
Intervention Type
Drug
Intervention Name(s)
Cilostazol
Intervention Description
Cilostazol 200 mg/day
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Aspirin 100 mg/day
Primary Outcome Measure Information:
Title
Change of carotid artery atherosclerosis
Description
Plaque composition
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change of carotid artery atherosclerosis 1
Description
Changes in carotid intima-media thickness after treatment
Time Frame
6 months
Title
Change of carotid artery atherosclerosis 2
Description
Changes in carotid artery stenosis after treatment
Time Frame
6 months
Title
Change of carotid artery atherosclerosis 3
Description
Plaque volume in carotid artery
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Glucose metabolism 1
Description
HOMA-Insulin Resistance
Time Frame
6 months
Title
Diabetic complication
Description
Albuminuria
Time Frame
6 months
Title
Glucose metabolism 2
Description
HbA1c
Time Frame
6 months
Title
Body composition
Description
Body fat mass and percent
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 30 and 80 years Patients with type 2 diabetes on treatment (HbA1c 6.0-11.0%) Carotid plaque on 3D ultrasound Exclusion Criteria: Acute bleeding or bleeding tendency 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
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
20516379
Citation
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.
Results Reference
background
PubMed Identifier
24381128
Citation
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.
Results Reference
background
PubMed Identifier
32700396
Citation
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.
Results Reference
derived

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Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes

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