Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00886574

Acronym

CAPPA

Enrollment

400

Registered

2009-04-23

Start date

2009-04-30

Completion date

2014-02-28

Last updated

2010-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Cilostazol versus Aspirin, Anti-PLT drug, Primary Prevention of Atherosclerotic Events, Type 2 DM, Intima media thickness (IMT)

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.

Interventions

DRUGCilostazol

Cilostazol 200 mg (50 mg 2T twice per day)

DRUGAspirin

100 mg once a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026