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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Ajou University School of Medicine
Kyunghee University Medical Center
Korea University Guro Hospital
Inha University Hospital
Inje University
Hallym University Medical Center
Information provided by:
Hanyang University
ClinicalTrials.gov Identifier:
NCT00886574
First received: April 22, 2009
Last updated: June 3, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Cilostazol
Drug: Aspirin
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hanyang University:

Primary Outcome Measures:
  • Maximal and mean intima media thickness (IMT) of both common carotid artery of the cilostazol group in comparison with the aspirin group [ Time Frame: every 6 months following randomization, for 48 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Events of the ischemic heart disease [ Time Frame: every 12 months following randomization, for 48 months ] [ Designated as safety issue: Yes ]
  • Events of cerebrovascular disease [ Time Frame: every 12 months following randomization, for 48 months ] [ Designated as safety issue: Yes ]
  • Events of peripheral vascular disease [ Time Frame: every 12 months following randomization, for 48 months ] [ Designated as safety issue: Yes ]
  • Events of hemorrhagic vascular complication [ Time Frame: every 12 months following randomization, for 48 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: April 2009
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Pletaal

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886574

Locations
Korea, Republic of
Inha University Hospital
In Cheon, Korea, Republic of
Hallym University Hospital
Pyungcheon, Korea, Republic of
Kyung hee University Medical Center
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Hallym University Hospital
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Sponsors and Collaborators
Hanyang University
Ajou University School of Medicine
Kyunghee University Medical Center
Korea University Guro Hospital
Inha University Hospital
Inje University
Hallym University Medical Center
Investigators
Principal Investigator: Yongsoo Park, M.D. Ph.D Department of Internal Medicine, Hanyang University
  More Information

No publications provided

Responsible Party: Yongsoo, Park, M. D., Department of Internal Medicine, Hanyang University
ClinicalTrials.gov Identifier: NCT00886574     History of Changes
Other Study ID Numbers: HY-2009-11
Study First Received: April 22, 2009
Last Updated: June 3, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanyang University:
Cilostazol versus Aspirin
Anti-PLT drug
Primary Prevention of Atherosclerotic Events
Type 2 DM
Intima media thickness (IMT)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Aspirin
Cilostazol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
 Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Vasodilator Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 19, 2013