NCT04734353

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
492

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

1.4 years

First QC Date

August 18, 2020

Last Update Submit

January 28, 2021

Conditions

Coronary Artery Disease

Keywords

High-risk coronary artery diseasePrasugrelTicagrelor

Outcome Measures

Primary Outcomes (1)

  • Major bleeding and adherence to DAPT regimen

    Incidence of major bleeding (BARC type 2, 3 or 5) and prevalence of discontinuation/switch of antiplatelet regimen

    1 year after PCI

Secondary Outcomes (4)

  • MACE

    1 year after PCI

  • Major bleeding

    1 year after PCI

  • Major bleeding

    1 year post-PCI

  • Adherence to DAPT regimen

    1 year after PCI

Other Outcomes (3)

  • Platelet function test

    1 month after PCI

  • Bleeding assessment

    1 month after PCI

  • Dyspnea assessment

    1 month after PCI

Study Arms (2)

E5 group

EXPERIMENTAL

Escalation in CHIP

Drug: Prasugrel 5mg

T60 group

ACTIVE COMPARATOR

Escalation in CHIP

Drug: Ticagrelor 60mg

Interventions

Prasugrel 5mgDRUG

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

Also known as: Effient
E5 group
Ticagrelor 60mgDRUG

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

Also known as: Brillinta
T60 group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 19 and more; and
  • Subjects who scheduled for percutaneous coronary intervention(PCI) with Firehawk® drug-eluting stent
  • 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.

You may not qualify if:

  • Cardiogenic shock at the index admission
  • Bleeding tendency, congenital or acquired
  • 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)
  • Need for chronic oral anticoagulation
  • History of intracranial hemorrhage
  • Intracranial neoplasm, AV fistula or aneurysm
  • Platelet counts \< 100,000/mm3
  • Liver cirrhosis with ascites or coagulopathy
  • Dialysis-impending or -dependent renal failure
  • Pregnant and/or lactating women
  • Increased risk of bradycardia events (sick sinus, AV block grade II or III, bradycardia-induced syncope)
  • 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
  • Concurrent medical condition with a life expectancy of less than 1 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Gyeongsang National University Changwon Hospital

Changwon, Gyeongsangnam-do, 51472, South Korea

RECRUITING

Gyeongsang National University Hospita

Jinju, Gyeongsangnam-do, South Korea

RECRUITING

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 626-770, South Korea

RECRUITING

Kosin University Gospel Hospital

Busan, 602-702, South Korea

NOT YET RECRUITING

Dong-A University Hospital

Busan, 602-714, South Korea

NOT YET RECRUITING

Pusan National University Hospital,

Busan, 602-739,, South Korea

NOT YET RECRUITING

Inje University Busan Paik Hospital,

Busan, South Korea

NOT YET RECRUITING

Ulsan University Hospital

Ulsan, South Korea

NOT YET RECRUITING

Related Publications (1)

  • Schupke S, Neumann FJ, Menichelli M, Mayer K, Bernlochner I, Wohrle J, Richardt G, Liebetrau C, Witzenbichler B, Antoniucci D, Akin I, Bott-Flugel L, Fischer M, Landmesser U, Katus HA, Sibbing D, Seyfarth M, Janisch M, Boncompagni D, Hilz R, Rottbauer W, Okrojek R, Mollmann H, Hochholzer W, Migliorini A, Cassese S, Mollo P, Xhepa E, Kufner S, Strehle A, Leggewie S, Allali A, Ndrepepa G, Schuhlen H, Angiolillo DJ, Hamm CW, Hapfelmeier A, Tolg R, Trenk D, Schunkert H, Laugwitz KL, Kastrati A; ISAR-REACT 5 Trial Investigators. Ticagrelor or Prasugrel in Patients with Acute Coronary Syndromes. N Engl J Med. 2019 Oct 17;381(16):1524-1534. doi: 10.1056/NEJMoa1908973. Epub 2019 Sep 1.

    PMID: 31475799RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Prasugrel HydrochlorideTicagrelor

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Young-Hoon Jeong, MD, PhD

    Changwon Gyeongsang National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young-Hoon Jeong, MD, PhD

CONTACT

82-55-214-3721goodoctor@naver.com

Jong-Hwa Ahn, MD, PhD

CONTACT

82-55-214-3724jonghwaahn@naver.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2020

First Posted

February 2, 2021

Study Start

January 15, 2020

Primary Completion

June 15, 2021

Study Completion

June 15, 2022

Last Updated

February 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(8)