Ignite Creation Date:
2024-05-06 @ 3:48 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02379676
Status:
UNKNOWN
Last Update Posted:
2016-07-06
First Post:
2015-02-28
Brief Title:
Effect of Ticagrelor Versus Clopidogrel on Endothelial Dysfunction and Vascular Inflammation
Sponsor:
Kiyuk Chang
Organization:
Seoul St Marys Hospital
Study Overview
Official Title:
Comparison of the Effects of Ticagrelor Versus Clopidogrel on Endothelial Dysfunction and Vascular Inflammation in Patients With Prior Non-ST-segment Acute Coronary Syndrome
Status:
UNKNOWN
Status Verified Date:
2016-07
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:
The purpose of this study is to compare the effects of ticagrelor and clopidogrel on endothelial dysfunction and vascular inflammation
Ticagrelor will lead to beneficial pleiotropic effects compared with treatment with clopidogrel in patients receiving a drug-eluting stents DES during percutaneous coronary intervention PCI for non-ST-segment acute coronary syndrome NSTE-ACS beyond 1 month after the index event Ticagrelor treatment will improve percent flow-mediated dilation FMD values and reduces inflammatory gene expression on peripheral blood mononuclear cells
Ticagrelor will lead to beneficial pleiotropic effects compared with treatment with clopidogrel in patients receiving a drug-eluting stents DES during percutaneous coronary intervention PCI for non-ST-segment acute coronary syndrome NSTE-ACS beyond 1 month after the index event Ticagrelor treatment will improve percent flow-mediated dilation FMD values and reduces inflammatory gene expression on peripheral blood mononuclear cells
Detailed Description:
The primary objective of this study lies in whether ticagrelor improves endothelial dysfunction compared to clopidogrel measured by endothelium-dependent flow-mediated dilation FMD The secondary objective is to demonstrate whether ticagrelor has an anti-atherosclerotic effect compared to clopidogrel in terms of reducing systemic low-grade inflammation Endpoints are 1 difference of flow-mediated dilation values and 2 messenger ribonucleic acid mRNA expression measured by quantitative real-time reverse transcription-polymerase chain reaction qRT-PCR of inflammation-associated key genes in circulation monocytes between non-ST-segment acute coronary syndrome patients treated with ticagrelor and clopidogrel
Patients who agree to participate study are screened at Visit 1 30 365 days after index percutaneous coronary intervention Patients with endothelial dysfunction defined as screening flow-mediated dilation are randomly assigned at Visit 2 07 days after screening test And then patients should receive study drugs according to allocated groups from the day of randomization Ticagrelor 90mg twice daily or clopidogrel 75mg daily will be maintained for 30 days Flow-mediated dilation are performed at screening and at Visit 3 day 30 from the treatment of study drugs and blood sampling are performed before the first dose of study drugs at Visit 2 and at Visit 3
Patients who agree to participate study are screened at Visit 1 30 365 days after index percutaneous coronary intervention Patients with endothelial dysfunction defined as screening flow-mediated dilation are randomly assigned at Visit 2 07 days after screening test And then patients should receive study drugs according to allocated groups from the day of randomization Ticagrelor 90mg twice daily or clopidogrel 75mg daily will be maintained for 30 days Flow-mediated dilation are performed at screening and at Visit 3 day 30 from the treatment of study drugs and blood sampling are performed before the first dose of study drugs at Visit 2 and at Visit 3
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