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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-26

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Carotid Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cilostazol group

Cilostazol 200 mg or maximal tolerate dose

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

Cilostazol 200 mg/day

Aspirin group

Aspirin 100 mg

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

Aspirin 100 mg/day

Interventions

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Cilostazol

Cilostazol 200 mg/day

Intervention Type DRUG

Aspirin

Aspirin 100 mg/day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo Lim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

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.

Reference Type BACKGROUND
PMID: 20516379 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24381128 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32700396 (View on PubMed)

Other Identifiers

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Cilostazol_Carotid a. plaque

Identifier Type: -

Identifier Source: org_study_id

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