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Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events

Information source: Hanyang University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Cilostazol (Drug); Aspirin (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Hanyang University

Official(s) and/or principal investigator(s):
Yongsoo Park, M.D. Ph.D, Principal Investigator, Affiliation: Department of Internal Medicine, Hanyang University


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.

Clinical Details

Official title: Multi-Center, Randomized, Open Label Study of the Efficacy of Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events With Korean Type 2 DM Patients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

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

Secondary outcome:

Events of the ischemic heart disease

Events of cerebrovascular disease

Events of peripheral vascular disease

Events of hemorrhagic vascular complication


Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Inha University Hospital, In Cheon, Korea, Republic of

Hallym University Hospital, Pyungcheon, Korea, Republic of

Hallym University Hospital, Seoul, Korea, Republic of

Korea University Guro Hospital, Seoul, Korea, Republic of

Kyung hee University Medical Center, Seoul, Korea, Republic of

Ajou University Hospital, Suwon, Korea, Republic of

Additional Information

Starting date: April 2009
Last updated: June 3, 2010

Page last updated: August 23, 2015

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