NCT03248401

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2016

Typical duration for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

2.1 years

First QC Date

August 9, 2017

Last Update Submit

April 6, 2020

Conditions

Type 2 Diabetes MellitusCarotid Atherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Change of carotid artery atherosclerosis

    Plaque composition

    6 months

Secondary Outcomes (3)

  • Change of carotid artery atherosclerosis 1

    6 months

  • Change of carotid artery atherosclerosis 2

    6 months

  • Change of carotid artery atherosclerosis 3

    6 months

Other Outcomes (4)

  • Glucose metabolism 1

    6 months

  • Diabetic complication

    6 months

  • Glucose metabolism 2

    6 months

  • +1 more other outcomes

Study Arms (2)

Cilostazol group

EXPERIMENTAL

Cilostazol 200 mg or maximal tolerate dose

Drug: Cilostazol

Aspirin group

ACTIVE COMPARATOR

Aspirin 100 mg

Drug: Aspirin

Interventions

CilostazolDRUG

Cilostazol 200 mg/day

Cilostazol group
AspirinDRUG

Aspirin 100 mg/day

Aspirin group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 20516379BACKGROUND

  • 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.

    PMID: 24381128BACKGROUND

  • 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.

    PMID: 32700396DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Carotid Artery Diseases

Interventions

CilostazolAspirin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 9, 2017

First Posted

August 14, 2017

Study Start

September 26, 2016

Primary Completion

October 21, 2018

Study Completion

December 31, 2019

Last Updated

April 8, 2020

Record last verified: 2020-04

Locations

KR(1)