Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events
Information source: Hanyang University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Cilostazol (Drug); Aspirin (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Hanyang University Official(s) and/or principal investigator(s): Yongsoo Park, M.D. Ph.D, Principal Investigator, Affiliation: Department of Internal Medicine, Hanyang University
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Maximal and mean intima media thickness (IMT) of both common carotid artery of the cilostazol group in comparison with the aspirin group
Secondary outcome: Events of the ischemic heart diseaseEvents of cerebrovascular disease Events of peripheral vascular disease Events of hemorrhagic vascular complication
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Inha University Hospital, In Cheon, Korea, Republic of
Hallym University Hospital, Pyungcheon, 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
Additional Information
Starting date: April 2009
Last updated: June 3, 2010
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