Effect of Cilostazol on Endothelial Progenitor Cells and Endothelial Function in High Risk for Cardiovascular Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 26 October 2015
• Main ID: NCT02194686
• Date of registration: 16/07/2014
• Prospective Registration: No
• Primary sponsor: National Cheng-Kung University Hospital
• Public title: Effect of Cilostazol on Endothelial Progenitor Cells and Endothelial Function in High Risk for Cardiovascular Disease
• Scientific title: Cilostazol Enhances the Number and Functions of Circulating Endothelial Progenitor Cells Mediated Through Multiple Mechanisms in Patients With High Risk for Cardiovascular Disease
• Date of first enrolment: January 2013
• Target sample size: 71
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02194686
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Taiwan

Contacts

• Name: Ting-Hsing Chao, MD
• Affiliation: National Cheng-Kung University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria: high-risk patients who have at least one of the following situations
without pre-existing cardiovascular disease including peripheral artery disease or
coronary artery disease:

- type 2 diabetes mellitus

- metabolic syndrome

- stage 3 (or more advanced) chronic kidney disease

- 2 or more coronary risk factors (male > 45 years or female > 55 years, hypertension,
tobacco smoking, hyperlipidemia, family history of cardiovascular disease)

Exclusion Criteria:

- ankle-brachial index less than 0.9 or more than 1.3 in one or both legs

- significant stenosis (more than 50% as compared to reference vessel) in peripheral
artery on image study

- symptoms suggesting peripheral artery disease in at least one leg

- clinical or electrocardiographic evidence of coronary artery disease

- clinical evidence of cerebrovascular disease

- severe liver dysfunction (transaminases >10 times of upper normal limit, history of
liver cirrhosis, or hepatoma)

- left ventricular ejection fraction (<50% by echocardiography)

- documented active malignancy

- chronic inflammatory disease

- known drug allergy history for cilostazol

- current use of cilostazol or any other cAMP-elevator

- premenopausal women



Age minimum: 20 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cardiovascular Diseases

Intervention(s)

Drug: Dummy Placebo

Drug: Cilostazol

Primary Outcome(s)

Circulating EPCs Number [Time Frame: 3 months]

Secondary Outcome(s)

Viability (Proliferation) of EPCs [Time Frame: 3 months]

Secondary ID(s)

NCKUH-10203022

B-BR-101-121

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Department of Health, Executive Yuan, R.O.C. (Taiwan)