Ignite Creation Date:
2024-05-06 @ 2:59 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02174939
Status:
UNKNOWN
Last Update Posted:
2015-10-14
First Post:
2014-06-22
Brief Title:
Effect of Cilostazol on Endothelial Progenitor Cells and Endothelial Function in Coronary Artery Disease
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
Study Overview
Official Title:
Cilostazol Enhances the Number and Functions of Circulating Endothelial Progenitor Cells and Endothelial Function Mediated Through Modification of Vasculogenesis and Angiogenesis Factors in Patients With Stable Coronary Artery Disease
Status:
UNKNOWN
Status Verified Date:
2015-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 The number and function of circulating endothelial progenitor cells EPCs are inversely associated with coronary risk factors and atherosclerotic diseases such as coronary artery disease CAD and cardiovascular high risk
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 CAD and cardiovascular high risk
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 CAD and cardiovascular high risk
Detailed Description:
1 titration of drugs
1 run-in period eligible subjects are screened and baseline blood samples are obtained
2 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
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 proliferationviability and apoptosis assays
3 measurement of flow-mediated dilatation FMD of left brachial artery by sonography
4 assessment of long-term cardiovascular outcomes
1 run-in period eligible subjects are screened and baseline blood samples are obtained
2 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
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 proliferationviability and apoptosis assays
3 measurement of flow-mediated dilatation FMD of left brachial artery by sonography
4 assessment of long-term cardiovascular outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCKUH-10304022 | OTHER_GRANT | NCKUH | None |