Status:
UNKNOWN
Prasugrel 5 mg vs. Ticagrelor 60 mg in CHIP (E5TION)
Lead Sponsor:
Gyeongsang National University Hospital
Collaborating Sponsors:
U&I Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
E5TION will evaluate the efficacy, safety and tolerability of tailored two regimens (prasugrel 5mg/d vs. ticagrelor 60mg bid) in high-risk patients undergoing PCI (CHIP: COmplex and Higher-Risk Indica...
Detailed Description
Because CHIP (COmplex and Higher-Risk Indicated PCI/PatieNts) has been related with the increased risk of ischemic events following PCI, there are unmet needs to develop the tailored strategies (e.g.,...
Eligibility Criteria
Inclusion
- Age 19 and more; and
- Subjects who scheduled for percutaneous coronary intervention(PCI) with Firehawk® drug-eluting stent
- At least one of the following high-risk factors;
- Clinical factors: diabetes, chronic kidney disease (GFR \< 60ml/min/1.73m2), LV dysfunction (LV EF \< 45%), or troponin (+).
- 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.
- High platelet reactivity: VerifyNow PRU ≥ 266.
Exclusion
- Cardiogenic shock at the index admission
- Bleeding tendency, congenital or acquired
- 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)
- Need for chronic oral anticoagulation
- History of intracranial hemorrhage
- Intracranial neoplasm, AV fistula or aneurysm
- Platelet counts \< 100,000/mm3
- Liver cirrhosis with ascites or coagulopathy
- Dialysis-impending or -dependent renal failure
- Pregnant and/or lactating women
- Increased risk of bradycardia events (sick sinus, AV block grade II or III, bradycardia-induced syncope)
- 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
- Concurrent medical condition with a life expectancy of less than 1 years
Key Trial Info
Start Date :
January 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2022
Estimated Enrollment :
492 Patients enrolled
Trial Details
Trial ID
NCT04734353
Start Date
January 15 2020
End Date
June 15 2022
Last Update
February 2 2021
Active Locations (8)
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1
Gyeongsang National University Changwon Hospital
Changwon, Gyeongsangnam-do, South Korea, 51472
2
Gyeongsang National University Hospita
Jinju, Gyeongsangnam-do, South Korea
3
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea, 626-770
4
Kosin University Gospel Hospital
Busan, South Korea, 602-702