NCT00886574

Brief Summary

This multi-center, randomized controlled study aims to evaluate the efficacy of Cilostazol versus Aspirin for primary prevention of atherosclerotic events with Korean type 2 Diabetes Mellitus (DM) patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

6 active sites

Status
unknown

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

April 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

June 4, 2010

Status Verified

May 1, 2010

Enrollment Period

1.8 years

First QC Date

April 22, 2009

Last Update Submit

June 3, 2010

Conditions

Type 2 Diabetes Mellitus

Keywords

Cilostazol versus AspirinAnti-PLT drugPrimary Prevention of Atherosclerotic EventsType 2 DMIntima media thickness (IMT)

Outcome Measures

Primary Outcomes (1)

  • Maximal and mean intima media thickness (IMT) of both common carotid artery of the cilostazol group in comparison with the aspirin group

    every 6 months following randomization, for 48 months

Secondary Outcomes (4)

  • Events of the ischemic heart disease

    every 12 months following randomization, for 48 months

  • Events of cerebrovascular disease

    every 12 months following randomization, for 48 months

  • Events of peripheral vascular disease

    every 12 months following randomization, for 48 months

  • Events of hemorrhagic vascular complication

    every 12 months following randomization, for 48 months

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

Aspirin 100 mg once a day

Drug: Aspirin

Cilostazol

ACTIVE COMPARATOR

Cilostazol 200 mg (50 mg 2T twice per day)

Drug: Cilostazol

Interventions

CilostazolDRUG

Cilostazol 200 mg (50 mg 2T twice per day)

Also known as: Pletaal
Cilostazol
AspirinDRUG

100 mg once a day

Aspirin

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus with high risk of macrovascular complications; high risk is one or more as follows:
  • Hypertension (≧ 140/90 or anti-hypertensive therapy)
  • Hypercholesterolemia (LDL-C \> 130 mg/dL or anti-hyperlipidemic therapy)
  • TG \> 200 mg/dL
  • Non proliferative retinopathy or macular edema
  • Microalbuminuria or macroalbuminuria
  • Smoker
  • Patients on no anti PLT drug history
  • Patients who are agree with this research

You may not qualify if:

  • Type 1 diabetes mellitus
  • Macrovascular complication history
  • Uncontrolled hypertension, unstable angina history
  • Congestive heart failure
  • Bleeding tendency
  • Chronic liver disease (ALT \> 100 or AST \> 100) or Chronic renal disease creatinine \> 3.0 mg/dl)
  • Anemia (hemoglobin \< 10 mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3)
  • Pregnant or lactation women
  • Plan to be revascularized in 4 weeks
  • Plan to go to surgery or invasive intervention in 4 weeks
  • Plan to need to admission for acute cardiovascular disease in 4 weeks
  • Contraindication of this medication
  • Other anti-PLT drug therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Inha University Hospital

Incheon, South Korea

Location

Hallym University Hospital

Pyungcheon, South Korea

Location

Hallym University Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Kyung hee University Medical Center

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

CilostazolAspirin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Yongsoo Park, M.D. Ph.D

    Department of Internal Medicine, Hanyang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 22, 2009

First Posted

April 23, 2009

Study Start

April 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2014

Last Updated

June 4, 2010

Record last verified: 2010-05

Locations

KR(6)