NCT04734353

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 492 (estimated)
• Sponsor: Gyeongsang National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Prasugrel 5mg	Prasugrel 20 mg loading, followed by prasugrel 5 mg/day for 12 months
DRUG	Ticagrelor 60mg	Ticagrelor 120 mg loading, followed by ticagrelor 60 mg bid for 12 months

Timeline

• Start date: 2020-01-15
• Primary completion: 2021-06-15
• Completion: 2022-06-15
• First posted: 2021-02-02
• Last updated: 2021-02-02

Locations

8 sites across 1 country: South Korea