Prasugrel 5 mg vs. Ticagrelor 60 mg in CHIP (E5TION)

• Status: Recruiting
• Trial end date: 2022-06-15
• Target enrollment: 0
• Participant gender: All

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 Indicated PCI/PatieNts).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gyeongsang National University Hospital
• Collaborator: U&I Corporation
• Treatments: Prasugrel Hydrochloride; Ticagrelor

Criteria

Inclusion Criteria:

1. Age 19 and more; and

2. Subjects who scheduled for percutaneous coronary intervention(PCI) with Firehawk® drug-eluting stent

3. 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 Criteria:

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