Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events

Type 2 Diabetes Mellitus Clinical Trial

— CAPPA  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00886574
• Other study ID #: HY-2009-11
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 22, 2009
• Last updated: June 3, 2010
• Start date: April 2009
• Est. completion date: February 2014

Study information

• Verified date: May 2010
• Source: Hanyang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: February 2014
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Cilostazol
Cilostazol 200 mg (50 mg 2T twice per day)
• Aspirin
100 mg once a day

Locations

Country	Name	City	State
Korea, Republic of	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

Sponsors (7)

Lead Sponsor	Collaborator
Hanyang University	Ajou University School of Medicine, Hallym University Medical Center, Inha University Hospital, Inje University, Korea University Guro Hospital, Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Events of the ischemic heart disease		every 12 months following randomization, for 48 months	Yes
Secondary	Events of cerebrovascular disease		every 12 months following randomization, for 48 months	Yes
Secondary	Events of peripheral vascular disease		every 12 months following randomization, for 48 months	Yes
Secondary	Events of hemorrhagic vascular complication		every 12 months following randomization, for 48 months	Yes