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

Last updated: January 28, 2021
Sponsor: Gyeongsang National University Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Thrombosis

Atherosclerosis

Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT04734353
E-5TION
  • Ages > 19
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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), LVdysfunction (LV EF < 45%), or troponin (+).
  • Lesion- or procedure-related factors: left main PCI, chronic totalocclusion, bifurcation lesion requiring two-stent technique, severecalcification, in-stent restenosis, multi-vessel PCI (≥ 2 vessels requiringstent implantation), PCI for ≥ 3 lesions, ≥ 3 stents implanted, or totalstent length > 60 mm.
  • High platelet reactivity: VerifyNow PRU ≥ 266.

Exclusion

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 ahigh-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), CYP3Asubstrates with narrow therapeutic indices (e.g., cyclosporine, quinidine), or strongCYP3A 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

Study Design

Total Participants: 492
Study Start date:
January 15, 2020
Estimated Completion Date:
June 15, 2022

Study 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.

Connect with a study center

  • Gyeongsang National University Changwon Hospital

    Changwon, Gyeongsangnam-do 51472
    Korea, Republic of

    Active - Recruiting

  • Gyeongsang National University Hospita

    Jinju, Gyeongsangnam-do
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do 626-770
    Korea, Republic of

    Active - Recruiting

  • Dong-A University Hospital

    Busan, 602-714
    Korea, Republic of

    Site Not Available

  • Inje University Busan Paik Hospital,

    Busan,
    Korea, Republic of

    Site Not Available

  • Kosin University Gospel Hospital

    Busan, 602-702
    Korea, Republic of

    Site Not Available

  • Pusan National University Hospital,

    Busan, 602-739,
    Korea, Republic of

    Site Not Available

  • Ulsan University Hospital

    Ulsan,
    Korea, Republic of

    Site Not Available

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