Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events

Phase 4

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Cilostazol; Drug: Aspirin

• Registration Number: NCT00886574
• Lead Sponsor: Hanyang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-22
• Study First Submitted QC: 2009-04-22
• Study First Posted: 2009-04-23
• Status Verified: 2010-05
• Last Update Submitted: 2010-06-03
• Last Update Posted: 2010-06-04
• Primary Completion: 2011-02
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cilostazol	Cilostazol	Cilostazol 200 mg (50 mg 2T twice per day)
Aspirin	Aspirin	Aspirin 100 mg once a day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Inha University Hospital; 🇰🇷 In Cheon, 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