Effect of Ticagrelor Versus Clopidogrel on Endothelial Dysfunction and Vascular Inflammation

Launched by KIYUK CHANG · Mar 4, 2015

Keywords

ClinConnect Summary

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 ...

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Eligibility criteria

• Inclusion Criteria:
• • Provision of informed consent prior to any study specific procedures
• • Men and women ≥20 years of age
• • Documented history of non-ST-segment acute coronary syndrome occurring 30 \~ 365 days prior to randomization and successfully treated with percutaneous coronary intervention using drug-eluting stent
• • Patient currently prescribed and tolerating aspirin 100mg and clopidogrel 75mg.
• • Patient who have demonstrated endothelial dysfunction defined as percent flow-mediated dilation values lower than 7% at baselines test
• Exclusion Criteria:
• • Patients with angina related symptoms
• • Patients who did not undergo or failed invasive treatment
• • Patients with a history of hypersensitivity to ticagrelor or clopidogrel
• • Patients who took an anti-coagulant, anti-thrombotic regularly before the study, or plan to have continuous treatment during the study
• • Patients who took vasoactive agents or caffeine ingestion for \<48
• • Patients with decompensated congestive heart failure of cardiogenic shock (Killip classification III or IV)
• • Patients with intractable arrhythmia
• • Patients with intractable arrhythmia
• • Patients with second or third degree atrioventricular block
• • Patients with uncontrolled hypertension
• • Patients with high risk of hemorrhage like blood coagulation disorders, gastrointestinal bleeding, gross hematuria, intraocular bleeding, hemorrhagic stroke, intracranial hemorrhage
• • Patients with more than moderate chronic obstructive pulmonary disease diagnosed by symptoms or documented by pulmonary function test
• • Patients who required renal replacement therapy
• • Patients with moderate to severe hepatic impairment
• • Patients with platelet \<100,000/μL
• • Patients with hematocrit \<30%
• • Concomitant oral or parenteral therapy with strong cytochrome P450 3A4 inhibitors, cytochrome P450 3A substrates with narrow therapeutic indices, or strong cytochrome P450 3A4 inducers i) Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (but not erythromycin or azithromycin), nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir, over 1 litre daily of grapefruit juice ii) Substrates with narrow therapeutic index: cyclosporine, quinidine, simvastatin at doses \>40 mg daily or lovastatin at doses \>40 mg daily iii) Strong inducers: rifampin/rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital
• • Patient who need to take drugs other than study medications and allowed concomitant medications during study period.
• • Patients who have planned elective surgery or invasive procedure requiring temporary discontinued study medication during study period.
• • Patients who are pregnant, breast feeding and not using medically acceptable birth control.
• • Patients considered as unsuitable based on medical judgment by investigators.