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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Prasugrel 5mg
Ticagrelor 60mg
Sponsored by
Gyeongsang National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring High-risk coronary artery disease, Prasugrel, Ticagrelor

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gyeongsang National University Changwon HospitalRecruiting
  • Gyeongsang National University HospitaRecruiting
  • Pusan National University Yangsan HospitalRecruiting
  • Kosin University Gospel Hospital
  • Dong-A University Hospital
  • Pusan National University Hospital,
  • Inje University Busan Paik Hospital,
  • Ulsan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

E5 group

T60 group

Arm Description

Escalation in CHIP

Escalation in CHIP

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

MACE
Incidence of MACE (CV death, myocardial infarction, stent thrombosis, stroke or urgent revascularization)
Major bleeding
Incidence of BARC type 2, 3 or 5 bleeding
Major bleeding
Incidence of ISTH major bleeding or clinically relevant non-major (CRNM) bleeding
Adherence to DAPT regimen
Prevalence of discontinuation/switch of antiplatelet regimen d/t side effect

Full Information

First Posted
August 18, 2020
Last Updated
January 28, 2021
Sponsor
Gyeongsang National University Hospital
Collaborators
U&I Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04734353
Brief Title
Prasugrel 5 mg vs. Ticagrelor 60 mg in CHIP (E5TION)
Acronym
E-5TION
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
June 15, 2021 (Anticipated)
Study Completion Date
June 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gyeongsang National University Hospital
Collaborators
U&I Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
High-risk coronary artery disease, Prasugrel, Ticagrelor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
492 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
E5 group
Arm Type
Experimental
Arm Description
Escalation in CHIP
Arm Title
T60 group
Arm Type
Active Comparator
Arm Description
Escalation in CHIP
Intervention Type
Drug
Intervention Name(s)
Prasugrel 5mg
Other Intervention Name(s)
Effient
Intervention Description
Prasugrel 20 mg loading, followed by prasugrel 5 mg/day for 12 months
Intervention Type
Drug
Intervention Name(s)
Ticagrelor 60mg
Other Intervention Name(s)
Brillinta
Intervention Description
Ticagrelor 120 mg loading, followed by ticagrelor 60 mg bid for 12 months
Primary Outcome Measure Information:
Title
Major bleeding and adherence to DAPT regimen
Description
Incidence of major bleeding (BARC type 2, 3 or 5) and prevalence of discontinuation/switch of antiplatelet regimen
Time Frame
1 year after PCI
Secondary Outcome Measure Information:
Title
MACE
Description
Incidence of MACE (CV death, myocardial infarction, stent thrombosis, stroke or urgent revascularization)
Time Frame
1 year after PCI
Title
Major bleeding
Description
Incidence of BARC type 2, 3 or 5 bleeding
Time Frame
1 year after PCI
Title
Major bleeding
Description
Incidence of ISTH major bleeding or clinically relevant non-major (CRNM) bleeding
Time Frame
1 year post-PCI
Title
Adherence to DAPT regimen
Description
Prevalence of discontinuation/switch of antiplatelet regimen d/t side effect
Time Frame
1 year after PCI
Other Pre-specified Outcome Measures:
Title
Platelet function test
Description
VerifyNow PRU
Time Frame
1 month after PCI
Title
Bleeding assessment
Description
Assessment of BARC bleeding based on dedicated bleeding questionnaire
Time Frame
1 month after PCI
Title
Dyspnea assessment
Description
Assessment of dyspnea based on dedicated dyspnea questionnaire
Time Frame
1 month after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young-Hoon Jeong, MD, PhD
Phone
82-55-214-3721
Email
goodoctor@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jong-Hwa Ahn, MD, PhD
Phone
82-55-214-3724
Email
jonghwaahn@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Hoon Jeong, MD, PhD
Organizational Affiliation
Changwon Gyeongsang National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gyeongsang National University Changwon Hospital
City
Changwon
State/Province
Gyeongsangnam-do
ZIP/Postal Code
51472
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Hoon Jeong, MD, PhD
Phone
82-55-214-3721
Email
goodoctor@naver.com
Facility Name
Gyeongsang National University Hospita
City
Jinju
State/Province
Gyeongsangnam-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-sin Koh, MD, PhD
Email
kjs0175@gmail.com
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeongsangnam-do
ZIP/Postal Code
626-770
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong-Su Kim, MD, PhD
Email
j25ngsukim@gmail.com
Facility Name
Kosin University Gospel Hospital
City
Busan
ZIP/Postal Code
602-702
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Ho Heo, MD, PhD
Email
duggymdc@hanmail.net
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
602-714
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moo Hyun Kim, MD, PhD
Email
kimmh@dau.ac.kr
Facility Name
Pusan National University Hospital,
City
Busan
ZIP/Postal Code
602-739,
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Sup Park, MD, PhD
Email
dr.jinsup@gmail.com
Facility Name
Inje University Busan Paik Hospital,
City
Busan
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae-Hyun Yang, MD, PhD
Email
yangthmd@naver.com
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gyung-Min Park, MD, PhD
Email
0733719@uuh.ulsan.kr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31475799
Citation
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.
Results Reference
result

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

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