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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cilostazol
Aspirin
Sponsored by
Hanyang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes Mellitus focused on measuring Cilostazol versus Aspirin, Anti-PLT drug, Primary Prevention of Atherosclerotic Events, Type 2 DM, Intima media thickness (IMT)

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Inha University Hospital
  • Hallym University Hospital
  • Hallym University Hospital
  • Korea University Guro Hospital
  • Kyung hee University Medical Center
  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Aspirin

Cilostazol

Arm Description

Aspirin 100 mg once a day

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

Outcomes

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

Secondary Outcome Measures

Events of the ischemic heart disease
Events of cerebrovascular disease
Events of peripheral vascular disease
Events of hemorrhagic vascular complication

Full Information

First Posted
April 22, 2009
Last Updated
June 3, 2010
Sponsor
Hanyang University
Collaborators
Ajou University School of Medicine, Kyunghee University Medical Center, Korea University Guro Hospital, Inha University Hospital, Inje University, Hallym University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00886574
Brief Title
Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
February 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hanyang University
Collaborators
Ajou University School of Medicine, Kyunghee University Medical Center, Korea University Guro Hospital, Inha University Hospital, Inje University, Hallym University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Cilostazol versus Aspirin, Anti-PLT drug, Primary Prevention of Atherosclerotic Events, Type 2 DM, Intima media thickness (IMT)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aspirin
Arm Type
Active Comparator
Arm Description
Aspirin 100 mg once a day
Arm Title
Cilostazol
Arm Type
Active Comparator
Arm Description
Cilostazol 200 mg (50 mg 2T twice per day)
Intervention Type
Drug
Intervention Name(s)
Cilostazol
Other Intervention Name(s)
Pletaal
Intervention Description
Cilostazol 200 mg (50 mg 2T twice per day)
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
100 mg once a day
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Events of the ischemic heart disease
Time Frame
every 12 months following randomization, for 48 months
Title
Events of cerebrovascular disease
Time Frame
every 12 months following randomization, for 48 months
Title
Events of peripheral vascular disease
Time Frame
every 12 months following randomization, for 48 months
Title
Events of hemorrhagic vascular complication
Time Frame
every 12 months following randomization, for 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Patients on no anti PLT drug history Patients who are agree with this research Exclusion Criteria: Type 1 diabetes mellitus Macrovascular complication history Uncontrolled hypertension, unstable angina history Congestive heart failure Bleeding tendency Chronic liver disease (ALT > 100 or AST > 100) or Chronic renal disease creatinine > 3.0 mg/dl) Anemia (hemoglobin < 10 mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3) Pregnant or lactation women Plan to be revascularized in 4 weeks Plan to go to surgery or invasive intervention in 4 weeks Plan to need to admission for acute cardiovascular disease in 4 weeks Contraindication of this medication Other anti-PLT drug therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongsoo Park, M.D. Ph.D
Organizational Affiliation
Department of Internal Medicine, Hanyang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inha University Hospital
City
In Cheon
Country
Korea, Republic of
Facility Name
Hallym University Hospital
City
Pyungcheon
Country
Korea, Republic of
Facility Name
Hallym University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung hee University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of

12. IPD Sharing Statement

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Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events

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