Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events

• Status: Unknown status
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanyang University
• Collaborators: Ajou University School of Medicine; Hallym University Medical Center; Inha University Hospital; Inje University; Korea University Guro Hospital; Kyunghee University Medical Center
• Treatments: Aspirin; Cilostazol

Criteria

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