Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatments cilostazol, aspirin
Phase phase 4
Sponsor Hanyang University
Collaborator Ajou University School of Medicine
Start date April 2009
End date February 2011
Trial size 400 participants
Trial identifier NCT00886574, HY-2009-11

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Aspirin 100 mg once a day
aspirin
100 mg once a day
(Active Comparator)
Cilostazol 200 mg (50 mg 2T twice per day)
cilostazol Pletaal
Cilostazol 200 mg (50 mg 2T twice per day)

Primary Outcomes

Measure
Maximal and mean intima media thickness (IMT) of both common carotid artery of the cilostazol group in comparison with the aspirin group
time frame: every 6 months following randomization, for 48 months

Secondary Outcomes

Measure
Events of the ischemic heart disease
time frame: every 12 months following randomization, for 48 months
Events of cerebrovascular disease
time frame: every 12 months following randomization, for 48 months
Events of peripheral vascular disease
time frame: every 12 months following randomization, for 48 months
Events of hemorrhagic vascular complication
time frame: every 12 months following randomization, for 48 months

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

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
Principal investigator Yongsoo Park, M.D. Ph.D
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by Hanyang University.