Efficacy, Safety and Tolerability of PrasugrEl 5mg or TIcagrelor 60mg in COmplex and Higher-Risk Indicated PCI/PatieNts: The prospective, randomized, open-labeled, blinded endpoint (PROBE), multi-center E5TION trial

Gyeongsang National University Changwon Hospital0 个研究点目标入组 492 人开始时间: 待定最近更新: 2020年3月23日

适应症

试验速览

暂无简介。

•1. Age 19 and more
•2. Subjects who scheduled for percutaneous coronary intervention(PCI) with Firehawk® drug-eluting stent
•3. At least one of the following high-risk factors;
•1) Clinical factors: diabetes, chronic kidney disease (GFR < 60ml/min/1.73m2), LV dysfunction (LV EF < 45%), or troponin (+).
•2) Lesion- or procedure-related factors: left main PCI, chronic total occlusion, bifurcation lesion requiring two-stent technique, severe calcification, in-stent restenosis, multi-vessel PCI (= 2 vessels requiring stent implantation), PCI for = 3 lesions, = 3 stents implanted, or total stent length > 60 mm.
•3) High platelet reactivity: VerifyNow PRU = 266.

•1. Cardiogenic shock at the index admission
•2. Bleeding tendency, congenital or acquired
•3. Active bleeding or high-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a high-risk for bleeding, malignancies with a high-risk for bleeding)
•4. Need for chronic oral anticoagulation
•5. History of intracranial hemorrhage
•6. Intracranial neoplasm, AV fistula or aneurysm
•7. Platelet counts < 100,000/mm3
•8. Liver cirrhosis with ascites or coagulopathy
•9. Dialysis-impending or -dependent renal failure
•10. Pregnant and/or lactating women
•11. Increased risk of bradycardia events (sick sinus, AV block grade II or III, bradycardia-induced syncope)
•12. Concomitant oral or i.v. therapy with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice >1L/day), CYP3A substrates with narrow therapeutic indices (e.g., cyclosporine, quinidine), or strong CYP3A inducers
•(e.g., rifampin/ rifampicin, phenytoin, carbamazepine, dexamethason, phenobarbital) that cannot be safely discontinued
•13. Concurrent medical condition with a life expectancy of less than 1 years

发起方

Gyeongsang National University Changwon Hospital