Status:
UNKNOWN
Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events
Lead Sponsor:
Hanyang University
Collaborating Sponsors:
Ajou University School of Medicine
Kyunghee University Medical Center
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
40+ years
Phase:
PHASE4
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) pat...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2014
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00886574
Start Date
April 1 2009
End Date
February 1 2014
Last Update
June 4 2010
Active Locations (6)
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1
Inha University Hospital
Incheon, South Korea
2
Hallym University Hospital
Pyungcheon, South Korea
3
Hallym University Hospital
Seoul, South Korea
4
Korea University Guro Hospital
Seoul, South Korea