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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

492 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2022-06-15

Brief Summary

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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).

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Detailed Description

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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., intensified antiplatelet treatment) for this cohort. During antithrombotic treatment, East Asian patients have been prone to bleed compared with Western patients ("East Asian Paradox"). For example, standard-dose potent P2Y12 inhibitors (e.g., ticagrelor, prasugrel) vs. clopidogrel did not demonstrate the better net clinical benefit in patients with acute coronary syndrome. One of the tailored antiplatelet strategies for East Asian patients would be the de-escalated strategy of potent P2Y12 inhibitors (e.g., ticagrelor, prasugrel). The ISAR-REACT5 trial showed the lower ischemic event and better tolerability of ticagrelor vs. prasugrel in ACS patients. This E5TION trial will compare the efficacy, safety and tolerability of the de-escalated strategies (low-dose prasugrel and ticagrelor) in East Asian patients with CHIP character.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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E5 group

Escalation in CHIP

Group Type EXPERIMENTAL

Prasugrel 5mg

Intervention Type DRUG

Prasugrel 20 mg loading, followed by prasugrel 5 mg/day for 12 months

T60 group

Escalation in CHIP

Group Type ACTIVE_COMPARATOR

Ticagrelor 60mg

Intervention Type DRUG

Ticagrelor 120 mg loading, followed by ticagrelor 60 mg bid for 12 months

Interventions

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Prasugrel 5mg

Prasugrel 20 mg loading, followed by prasugrel 5 mg/day for 12 months

Intervention Type DRUG

Ticagrelor 60mg

Ticagrelor 120 mg loading, followed by ticagrelor 60 mg bid for 12 months

Intervention Type DRUG

Other Intervention Names

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Effient Brillinta

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No