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 ongoing, but not recruiting participants.

First Received on April 22, 2009. Last Updated on June 3, 2010 History of Changes

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 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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2

Drug Information available for: Aspirin 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
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:

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

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 24, 2012