Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Cilostazol (Drug); Aspirin (Drug)

Phase: Phase 4

Status: 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

Overall contact:
Yongsoo Park, M. D. Ph. D, Phone: 82- 31-560-2239, Email: parkys@hanyang.ac.kr

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.

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: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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 disease

Events of cerebrovascular disease

Events of peripheral vascular disease

Events of hemorrhagic vascular complication

Minimum age: 40 Years. Maximum age: 75 Years. 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

Yongsoo Park, M. D. Ph. D, Phone: 82- 31-560-2239, Email: parkys@hanyang.ac.kr

Kyung hee University Medical Center, Seoul, Korea, Republic of; Recruiting
Young-Seol Kim, MD, PhD, Phone: 82-2-958-8128, Email: kimys@khmc.or.kr
Young-Seol Kim, MD, PhD, Principal Investigator

Ajou University Hospital, Suwon, Korea, Republic of; Recruiting
Kwan- Woo Lee, MD, PhD, Phone: 82-31-219-4526, Email: lkw65@ajou.ac.kr
Kwan Woo Lee, MD, PhD, Principal Investigator

Korea University Guro Hospital, Seoul, Korea, Republic of; Recruiting
Sei-Hyun Baik, MD. PhD, Phone: 82-2-818-6645, Email: 103hyun@korea.ac.kr
Sei-Hyun Baik, MD,PhD, Principal Investigator

Inha University Hospital, In Cheon, Korea, Republic of; Recruiting
Moon-suk Nam, MD, PhD, Phone: 82-32-890-3495, Email: namms@inha.ac.kr
Moon-Suk Nam, MD, PhD, Principal Investigator

Hallym University Hospital, Pyungcheon, Korea, Republic of; Recruiting
Jun- Goo Kang, MD.PhD, Phone: 82-10-8763-8775, Email: kjg0804@empal.com
Jun-Goo Kang, MD,PhD, Principal Investigator

Hallym University Hospital, Seoul, Korea, Republic of; Recruiting
Doo- Man Kim, Phone: 82-2-2224-2575, Email: dmjmsy@hanmail.net
Doo-Man Kim, MD, PhD, Principal Investigator

Starting date: April 2009
Ending date: February 2014
Last updated: April 22, 2009