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

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03248401
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
39.1
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Cilostazol, a Phosphodiesterase 3 Inhibitor, on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
Actual Study Start Date :
Sep 26, 2016
Actual Primary Completion Date :
Oct 21, 2018
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cilostazol group

Cilostazol 200 mg or maximal tolerate dose

Drug: Cilostazol
Cilostazol 200 mg/day
Active Comparator: Aspirin group

Aspirin 100 mg

Drug: Aspirin
Aspirin 100 mg/day

Outcome Measures

Primary Outcome Measures

  1. Change of carotid artery atherosclerosis [6 months]

    Plaque composition

Secondary Outcome Measures

  1. Change of carotid artery atherosclerosis 1 [6 months]

    Changes in carotid intima-media thickness after treatment

  2. Change of carotid artery atherosclerosis 2 [6 months]

    Changes in carotid artery stenosis after treatment

  3. Change of carotid artery atherosclerosis 3 [6 months]

    Plaque volume in carotid artery

Other Outcome Measures

  1. Glucose metabolism 1 [6 months]

    HOMA-Insulin Resistance

  2. Diabetic complication [6 months]

    Albuminuria

  3. Glucose metabolism 2 [6 months]

    HbA1c

  4. Body composition [6 months]

    Body fat mass and percent

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Bundang Hospital Seongnam Gyeonggi Korea, Republic of 463-707

Sponsors and Collaborators

  • Seoul National University Bundang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Soo Lim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT03248401
Other Study ID Numbers:
  • Cilostazol_Carotid a. plaque
First Posted:
Aug 14, 2017
Last Update Posted:
Apr 8, 2020
Last Verified:
Apr 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carotid Artery Diseases
Atherosclerosis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Aspirin
Cilostazol

Study Results

No Results Posted as of Apr 8, 2020