Cilostazol Versus Aspirin for Primary Prevention of Atherosclerotic Events - Full Text View

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

This study is currently recruiting participants.

Verified by Hanyang University, April 2009

First Received: April 22, 2009 No Changes Posted

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
Information provided by:	Hanyang University
ClinicalTrials.gov Identifier:	NCT00886574

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 IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Diabetes

Drug Information available for: Acetylsalicylic acid Cilostazol

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
Aspirin: Active Comparator Aspirin 100 mg once a day	Drug: Aspirin 100 mg once a day
Cilostazol: Active Comparator Cilostazol 200 mg (50 mg 2T twice per day)	Drug: Cilostazol Cilostazol 200 mg (50 mg 2T twice per day)

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886574

Contacts

Contact: Yongsoo Park, M. D. Ph. D	82- 31-560-2239	parkys@hanyang.ac.kr
Contact: Minyoung Chun, M.D	82-2-2298-2283	sunrise91@hanmail.net

Locations

Korea, Republic of
Kyung hee University Medical Center	Recruiting
Seoul, Korea, Republic of
Contact: Young-Seol Kim, MD, PhD 82-2-958-8128 kimys@khmc.or.kr
Principal Investigator: Young-Seol Kim, MD, PhD
Ajou University Hospital	Recruiting
Suwon, Korea, Republic of
Contact: Kwan- Woo Lee, MD, PhD 82-31-219-4526 lkw65@ajou.ac.kr
Principal Investigator: Kwan Woo Lee, MD, PhD
Korea University Guro Hospital	Recruiting
Seoul, Korea, Republic of
Contact: Sei-Hyun Baik, MD. PhD 82-2-818-6645 103hyun@korea.ac.kr
Principal Investigator: Sei-Hyun Baik, MD,PhD
Hallym University Hospital	Recruiting
Seoul, Korea, Republic of
Contact: Doo- Man Kim 82-2-2224-2575 dmjmsy@hanmail.net
Principal Investigator: Doo-Man Kim, MD, PhD
Hallym University Hospital	Recruiting
Pyungcheon, Korea, Republic of
Contact: Jun- Goo Kang, MD.PhD 82-10-8763-8775 kjg0804@empal.com
Principal Investigator: Jun-Goo Kang, MD,PhD
Inha University Hospital	Recruiting
In Cheon, Korea, Republic of
Contact: Moon-suk Nam, MD, PhD 82-32-890-3495 namms@inha.ac.kr
Principal Investigator: Moon-Suk Nam, MD, PhD

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:	Department of Internal Medicine, Hanyang University ( Yongsoo, Park, M. D. )
Study ID Numbers:	HY-2009-11
Study First Received:	April 22, 2009
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00886574 History of Changes
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:

Anti-Inflammatory Agents
Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents
Neuroprotective Agents
Fibrin Modulating Agents
Aspirin
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Cilostazol

Metabolic Diseases
Cyclooxygenase Inhibitors
Diabetes Mellitus
Anti-Asthmatic Agents
Endocrine System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Autonomic Agents
Analgesics, Non-Narcotic
Diabetes Mellitus, Type 2
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010