E-5TION: Prasugrel 5 mg vs. Ticagrelor 60 mg in CHIP (E5TION)
Study Details
Study Description
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 Indicated PCI/PatieNts).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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., 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: E5 group Escalation in CHIP |
Drug: Prasugrel 5mg
Prasugrel 20 mg loading, followed by prasugrel 5 mg/day for 12 months
Other Names:
|
| Active Comparator: T60 group Escalation in CHIP |
Drug: Ticagrelor 60mg
Ticagrelor 120 mg loading, followed by ticagrelor 60 mg bid for 12 months
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Major bleeding and adherence to DAPT regimen [1 year after PCI]
Incidence of major bleeding (BARC type 2, 3 or 5) and prevalence of discontinuation/switch of antiplatelet regimen
Secondary Outcome Measures
- MACE [1 year after PCI]
Incidence of MACE (CV death, myocardial infarction, stent thrombosis, stroke or urgent revascularization)
- Major bleeding [1 year after PCI]
Incidence of BARC type 2, 3 or 5 bleeding
- Major bleeding [1 year post-PCI]
Incidence of ISTH major bleeding or clinically relevant non-major (CRNM) bleeding
- Adherence to DAPT regimen [1 year after PCI]
Prevalence of discontinuation/switch of antiplatelet regimen d/t side effect
Other Outcome Measures
- Platelet function test [1 month after PCI]
VerifyNow PRU
- Bleeding assessment [1 month after PCI]
Assessment of BARC bleeding based on dedicated bleeding questionnaire
- Dyspnea assessment [1 month after PCI]
Assessment of dyspnea based on dedicated dyspnea questionnaire
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 19 and more; and
-
Subjects who scheduled for percutaneous coronary intervention(PCI) with Firehawk® drug-eluting stent
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At least one of the following high-risk factors;
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Clinical factors: diabetes, chronic kidney disease (GFR < 60ml/min/1.73m2), LV dysfunction (LV EF < 45%), or troponin (+).
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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:
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Cardiogenic shock at the index admission
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Bleeding tendency, congenital or acquired
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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)
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Need for chronic oral anticoagulation
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History of intracranial hemorrhage
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Intracranial neoplasm, AV fistula or aneurysm
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Platelet counts < 100,000/mm3
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Liver cirrhosis with ascites or coagulopathy
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Dialysis-impending or -dependent renal failure
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Pregnant and/or lactating women
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Increased risk of bradycardia events (sick sinus, AV block grade II or III, bradycardia-induced syncope)
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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
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Concurrent medical condition with a life expectancy of less than 1 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gyeongsang National University Changwon Hospital | Changwon | Gyeongsangnam-do | Korea, Republic of | 51472 |
| 2 | Gyeongsang National University Hospita | Jinju | Gyeongsangnam-do | Korea, Republic of | |
| 3 | Pusan National University Yangsan Hospital | Yangsan | Gyeongsangnam-do | Korea, Republic of | 626-770 |
| 4 | Kosin University Gospel Hospital | Busan | Korea, Republic of | 602-702 | |
| 5 | Dong-A University Hospital | Busan | Korea, Republic of | 602-714 | |
| 6 | Pusan National University Hospital, | Busan | Korea, Republic of | 602-739, | |
| 7 | Inje University Busan Paik Hospital, | Busan | Korea, Republic of | ||
| 8 | Ulsan University Hospital | Ulsan | Korea, Republic of |
Sponsors and Collaborators
- Gyeongsang National University Hospital
- U&I Corporation
Investigators
- Principal Investigator: Young-Hoon Jeong, MD, PhD, Changwon Gyeongsang National University Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- E-5TION