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Effect of Ticagrelor Versus Clopidogrel on Endothelial Dysfunction and Vascular Inflammation

Endothelial Dysfunction Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 (0~7 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02379676
Study type Interventional
Source Seoul St. Mary's Hospital
Contact Kiyuk Chang, MD, PhD
Phone 82-2-2258-1139
Email kiyuk@catholic.ac.kr
Status Recruiting
Phase Phase 4
Start date January 2015
Completion date March 2017
View Details
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