Clinical trial NCT00886574: Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Cilostazol versus Aspirin
Anti-PLT drug
Primary Prevention of Atherosclerotic Events
Type 2 DM
Intima media thickness (IMT)
Lead sponsor: Hanyang University
Sponsor class: OTHER
Collaborators: name: Ajou University School of Medicine
name: Kyunghee University Medical Center
name: Korea University Guro Hospital
name: Inha University Hospital
name: Inje University
name: Hallym University Medical Center
First posted: 2009-04-23
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

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
timeFrame: every 6 months following randomization, for 48 months
Secondary outcomes:
measure: Events of the ischemic heart disease
timeFrame: every 12 months following randomization, for 48 months
measure: Events of cerebrovascular disease
timeFrame: every 12 months following randomization, for 48 months
measure: Events of peripheral vascular disease
timeFrame: every 12 months following randomization, for 48 months
measure: Events of hemorrhagic vascular complication
timeFrame: every 12 months following randomization, for 48 months
Other outcomes:
Locations:
city: In Cheon
country: Korea, Republic of
facility: Inha University Hospital
city: Pyungcheon
country: Korea, Republic of
facility: Hallym University Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung hee University Medical Center
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Department of Internal Medicine, Hanyang University
name: Yongsoo Park, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
References: