Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events

NCT ID: NCT00886574

Last Updated: 2010-06-04

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Aspirin

Aspirin 100 mg once a day

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

100 mg once a day

Cilostazol

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

Group Type ACTIVE_COMPARATOR

Cilostazol

Intervention Type DRUG

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

Interventions

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Cilostazol

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

Intervention Type DRUG

Aspirin

100 mg once a day

Intervention Type DRUG

Other Intervention Names

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Pletaal

Eligibility Criteria

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Inclusion Criteria

1. 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
2. Patients on no anti PLT drug history
3. Patients who are agree with this research

Exclusion Criteria

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

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ajou University School of Medicine

OTHER

Sponsor Role collaborator

Kyunghee University Medical Center

OTHER

Sponsor Role collaborator

Korea University Guro Hospital

OTHER

Sponsor Role collaborator

Inha University Hospital

OTHER

Sponsor Role collaborator

Inje University

OTHER

Sponsor Role collaborator

Hallym University Medical Center

OTHER

Sponsor Role collaborator

Hanyang University

OTHER

Sponsor Role lead

Responsible Party

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Department of Internal Medicine, Hanyang University

Principal Investigators

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Yongsoo Park, M.D. Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Hanyang University

Locations

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Inha University Hospital

Incheon, , South Korea

Site Status

Hallym University Hospital

Pyungcheon, , South Korea

Site Status

Hallym University Hospital

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Kyung hee University Medical Center

Seoul, , South Korea

Site Status

Ajou University Hospital

Suwon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HY-2009-11

Identifier Type: -

Identifier Source: org_study_id

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