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Cardiovascular DiseasesPhase 4NCT02194686

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

A Phase 4 study testing Cilostazol in people with Cardiovascular Diseases, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

1. The number and function of circulating endothelial progenitor cells (EPCs) are inversely associated with coronary risk factors and atherosclerotic diseases. 2. This double-blind, randomized, placebo-controlled trial to evaluate the effects of cilostazol on human early EPCs and endothelial function as well as the… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Cardiovascular Diseases
What is being tested?
Cilostazol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
71 participants
Where
1 siteTaiwan
Study dates
Jan 2013to Aug 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Cheng Kung University Hospital

    Tainan, 704

Other trials in Taiwan

About this study

Official title: Cilostazol Enhances the Number and Functions of Circulating Endothelial Progenitor Cells Mediated Through Multiple Mechanisms in Patients With High Risk for Cardiovascular Disease

  1. The number and function of circulating endothelial progenitor cells (EPCs) are inversely associated with coronary risk factors and atherosclerotic diseases.
  2. This double-blind, randomized, placebo-controlled trial to evaluate the effects of cilostazol on human early EPCs and endothelial function as well as the potential mechanisms of action in patients with high risk for cardiovascular disease.
Read the detailed description
  1. titration of drugs
  2. run-in period: eligible subjects are screened and baseline blood samples are obtained
  3. study period: 12 weeks
  • subjects with cilostazol and subjects with dummy placebo
  • On the first day after the end of the study period, the follow-up data are obtained by the same procedure
  1. blood sampling and measurement of serum biomarkers
  • obtained from peripheral veins in all study subjects at the run-in period and the end of the treatment period of the study
  • sent for isolation, cell culture, and assays of human EPCs
  • also stored for enzyme-linked immunosorbent assay (stromal cell derived factor-alfa1, adiponectin, soluble thrombomodulin, vascular endothelial growth factor)
  1. assays of human EPCs
  2. colony formation by EPCs
  3. quantification of EPCs and apoptotic endothelial cells
  4. chemotactic motility, proliferation/viability and apoptosis assays
  5. measurement of flow-mediated dilatation (FMD) of left brachial artery by sonography
Being tested
Cilostazol, Dummy Placebo
Keywords
cilostazol, progenitor cells, cardiovascular disease, risk factors, angiogenesis, biological markers, endothelial function
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CilostazolDrug

    Also called Pletaal (brand name)

    One tablet (100 mg) twice per day for 12 weeks

  • Dummy PlaceboDrug

    Also called Placebo, Control

    One tablet twice per day for 12 weeks

Study groups in NCT02194686
Study groupRoleWhat they receive
CilostazolActive comparatorOne tablet (100 mg) twice per day for 12 weeks
Receives: Drug: Cilostazol
Dummy PlaceboPlacebo comparatorOne tablet twice per day for 12 weeks
Receives: Drug: Dummy Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Circulating EPCs Number

    Peripheral blood mononuclear cells (one million cells in each) are suspended in 100 µL phosphate-buffered saline and incubated for 30 min with monoclonal antibodies against human peridinin chlorophyll protein-conjugated cluster of differentiation antigen-45, phycoerythrin-conjugated anti-human cluster of differentiation antigen-34 antibody and anti-human kinase insert domain receptor (KDR) antibody conjugated with Alexa Flour 647. Cells are washed and analyzed on a FACSCalibur flow cytometer with 100,000 events in the lymphocyte gate. EPCs, which are defined as negative for cluster of differentiation antigen-45 and positive for cluster of differentiation antigen-34 and KDR. Based on the peripheral blood mononuclear cell counts, the absolute number of circulating EPCs/µL is calculated.

    Measured: 3 months

Secondary outcomes (1)

  1. Viability (Proliferation) of EPCs

    250,000 cells are seeded in each well of a 96-well plate and the cells are added with 200 μl of the culture medium and incubated at 37°C. Medium change is performed 3 days later. On 7th day, the plate is then re-incubated with 100 μl fresh medium and additional 50 μl of 2,3-Bis-(2-Methoxy-4-Nitro-5-Sulfophenyl)-2 Hydrogen-Tetrazolium-5-Carboxanilide reagent, and further incubated in dark at 37°C for 4 h. After incubation, the orange colored complex formed is read at 450 nm using a microplate reader with a 450 nm reference filter.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2014 (estimated)
  2. Study startJan 2013
  3. Primary completionMar 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02194686
Sponsor's protocol ID
B-BR-101-121
Other IDs
NCKUH-10203022
Status last verified
Oct 2015
First submitted
16 Jul 2014
Last updated
14 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Chao TH, Tseng SY, Li YH, Liu PY, Cho CL, Shi GY, Wu HL, Chen JH. A novel vasculo-angiogenic effect of cilostazol mediated by cross-talk between multiple signalling pathways including the ERK/p38 MAPK signalling transduction cascade. Clin Sci (Lond). 2012 Aug 1;123(3):147-59. doi: 10.1042/CS20110432.

    PubMed 22339730

  • Biscetti F, Pecorini G, Straface G, Arena V, Stigliano E, Rutella S, Locatelli F, Angelini F, Ghirlanda G, Flex A. Cilostazol promotes angiogenesis after peripheral ischemia through a VEGF-dependent mechanism. Int J Cardiol. 2013 Aug 10;167(3):910-6. doi: 10.1016/j.ijcard.2012.03.103. Epub 2012 Apr 2.

    PubMed 22473072

  • Chao TH, Tseng SY, Chen IC, Tsai YS, Huang YY, Liu PY, Ou HY, Li YH, Wu HL, Cho CL, Tsai LM, Chen JH. Cilostazol enhances mobilization and proliferation of endothelial progenitor cells and collateral formation by modifying vasculo-angiogenic biomarkers in peripheral arterial disease. Int J Cardiol. 2014 Mar 15;172(2):e371-4. doi: 10.1016/j.ijcard.2013.12.295. Epub 2014 Jan 11. No abstract available.

    PubMed 24439864

  • Chao TH, Chen IC, Li YH, Lee PT, Tseng SY. Plasma Levels of Proprotein Convertase Subtilisin/Kexin Type 9 Are Elevated in Patients With Peripheral Artery Disease and Associated With Metabolic Disorders and Dysfunction in Circulating Progenitor Cells. J Am Heart Assoc. 2016 May 20;5(5):e003497. doi: 10.1161/JAHA.116.003497.

    PubMed 27207972

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cilostazol in people with Cardiovascular Diseases, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Circulating EPCs Number (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02194686, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.

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