Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events (CAPPA)

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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Aspirin; Drug: Cilostazol

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • In Cheon, Korea, Republic of
    • Inha University Hospital
  • Pyungcheon, Korea, Republic of
    • HALLYM UNIVERSITY HOSPITAL
  • Seoul, Korea, Republic of
    • Kyung Hee University Medical Center
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • HALLYM UNIVERSITY HOSPITAL
  • Suwon, Korea, Republic of
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aspirin; Aspirin 100 mg once a day	Drug: Aspirin; 100 mg once a day
Active Comparator: Cilostazol; Cilostazol 200 mg (50 mg 2T twice per day)	Drug: Cilostazol; Cilostazol 200 mg (50 mg 2T twice per day); Other Names: Pletaal

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Hanyang University
• Collaborators: Korea University Guro Hospital; Ajou University School of Medicine; Inje University; Hallym University Medical Center; Kyunghee University Medical Center; Inha University Hospital
• Investigators: Principal Investigator: Yongsoo Park, M.D. Ph.D, Department of Internal Medicine, Hanyang University

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Anticipated): February 1, 2011
• Study Completion (Anticipated): February 1, 2014

Study Registration Dates

• First Submitted: April 22, 2009
• First Submitted That Met QC Criteria: April 22, 2009
• First Posted (Estimate): April 23, 2009

Study Record Updates

• Last Update Posted (Estimate): June 4, 2010
• Last Update Submitted That Met QC Criteria: June 3, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Type 2 DM; Cilostazol versus Aspirin; Anti-PLT drug; Primary Prevention of Atherosclerotic Events; Intima media thickness (IMT)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Neuroprotective Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Aspirin; Cilostazol
• Other Study ID Numbers: HY-2009-11