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Trial record 9 of 523 for:    aspirin AND prevention

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

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ClinicalTrials.gov Identifier: NCT00886574
Recruitment Status : Unknown
Verified May 2010 by Hanyang University.
Recruitment status was:  Active, not recruiting
First Posted : April 23, 2009
Last Update Posted : June 4, 2010
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

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Cilostazol Drug: Aspirin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2009
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


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 Name: Pletaal




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Events of the ischemic heart disease [ Time Frame: every 12 months following randomization, for 48 months ]
  2. Events of cerebrovascular disease [ Time Frame: every 12 months following randomization, for 48 months ]
  3. Events of peripheral vascular disease [ Time Frame: every 12 months following randomization, for 48 months ]
  4. Events of hemorrhagic vascular complication [ Time Frame: every 12 months following randomization, for 48 months ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886574


Locations
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, 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

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
First Posted: April 23, 2009    Key Record Dates
Last Update Posted: June 4, 2010
Last Verified: May 2010

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:
Aspirin
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cilostazol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors