Effect of Cilostazol Endothelial Progenitor Cells and Collateral Formation in Peripheral Occlusive Artery Disease (PAOD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-09-30

Brief Summary

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1. The number and function of circulating endothelial progenitor cells (EPCs) are inversely associated with coronary risk factors and atherosclerotic diseases such as PAOD.
2. This double-blind, randomized, placebo-controlled trial to evaluate the effects of cilostazol on human early EPCs and angiogenesis as well as the potential mechanisms of action in patients with mild-to-moderate PAOD.

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Detailed Description

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1. titration of drugs

1. run-in period: eligible subjects are screened and baseline blood samples are obtained
2. study period: 12 weeks

* 24 subjects with cilostazol and 20 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
3. 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)
2. assays of human EPCs

1. colony formation by EPCs
2. quantification of EPCs and apoptotic endothelial cells
3. chemotactic motility, proliferation/viability and apoptosis assays
3. collateral vessels formation and distal run-off assessed by dual-energy multi-slice computed tomography angiography
4. echocardiographic examinations to evaluate left ventricular functions

Conditions

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Peripheral Arterial Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cilostazol

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

Group Type ACTIVE_COMPARATOR

Cilostazol

Intervention Type DRUG

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

Dummy Placebo

One tablet twice per day for 12 weeks

Group Type PLACEBO_COMPARATOR

Dummy Placebo

Intervention Type DRUG

One tablet twice per day for 12 weeks

Interventions

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Cilostazol

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

Intervention Type DRUG

Dummy Placebo

One tablet twice per day for 12 weeks

Intervention Type DRUG

Other Intervention Names

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Pletaal (brand name) Placebo Control

Eligibility Criteria

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Inclusion Criteria

* ankle-brachial index (ABI) less than 0.9 in one or both legs but no obvious symptoms of intermittent claudication

Exclusion Criteria

* obvious symptoms of intermittent claudication
* severe PAD (Fontaine grading \> 3) or critical limb ischemia in at least one leg
* severe liver dysfunction (transaminases \>10 times of upper normal limit, history of liver cirrhosis, or hepatoma)
* \> stage 4 chronic kidney disease (end-stage renal disease with chronic dialysis not excluded)
* left ventricular ejection fraction \<50% by echocardiography
* documented active malignancy
* chronic inflammatory disease
* planned coronary intervention or endovascular therapy or bypass surgery within 3 months
* known drug allergy history for cilostazol
* current use of cilostazol or any other cAMP-elevator
* premenopausal women

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No