Coronary Artery DiseasePhase 4E-5TIONNCT04734353
Prasugrel 5 mg vs. Ticagrelor 60 mg in CHIP (E5TION)
A Phase 4 study testing Prasugrel 5mg and Ticagrelor 60mg in people with Coronary Artery Disease, run by Gyeongsang National University Hospital at 8 sites in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Prasugrel 5mg and Ticagrelor 60mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 492 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 15 Jan 2020to 15 Jun 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites, 8 recruiting
- Not yet recruiting
Kosin University Gospel Hospital
Busan, 602-702
Jung Ho Heo, MD, PhD, duggymdc@hanmail.net
- Not yet recruiting
Dong-A University Hospital
Busan, 602-714
Moo Hyun Kim, MD, PhD, kimmh@dau.ac.kr
- Not yet recruiting
Pusan National University Hospital,
Busan, 602-739,
Jin Sup Park, MD, PhD, dr.jinsup@gmail.com
- Not yet recruiting
Inje University Busan Paik Hospital,
Busan
Tae-Hyun Yang, MD, PhD, yangthmd@naver.com
- Recruiting
Gyeongsang National University Changwon Hospital
Changwon, Gyeongsangnam-do, 51472
Young-Hoon Jeong, MD, PhD, 82-55-214-3721, goodoctor@naver.com
- Recruiting
Gyeongsang National University Hospita
Jinju, Gyeongsangnam-do
Jin-sin Koh, MD, PhD, kjs0175@gmail.com
- Not yet recruiting
Ulsan University Hospital
Ulsan
Gyung-Min Park, MD, PhD, 0733719@uuh.ulsan.kr
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 626-770
Jeong-Su Kim, MD, PhD, j25ngsukim@gmail.com
About this study
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
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).
Read the 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
- Being tested
- Prasugrel 5mg, Ticagrelor 60mg
- Keywords
- High-risk coronary artery disease, Prasugrel, Ticagrelor
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prasugrel 5mgDrug
Also called Effient
Prasugrel 20 mg loading, followed by prasugrel 5 mg/day for 12 months
Ticagrelor 60mgDrug
Also called Brillinta
Ticagrelor 120 mg loading, followed by ticagrelor 60 mg bid for 12 months
| Study group | Role | What they receive |
|---|---|---|
| E5 group | Experimental | Escalation in CHIP Receives: Drug: Prasugrel 5mg |
| T60 group | Active comparator | Escalation in CHIP Receives: Drug: Ticagrelor 60mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year after PCI
Secondary outcomes (4)
MACE
Incidence of MACE (CV death, myocardial infarction, stent thrombosis, stroke or urgent revascularization)
Measured: 1 year after PCI
Major bleeding
Incidence of BARC type 2, 3 or 5 bleeding
Measured: 1 year after PCI
Major bleeding
Incidence of ISTH major bleeding or clinically relevant non-major (CRNM) bleeding
Measured: 1 year post-PCI
Adherence to DAPT regimen
Prevalence of discontinuation/switch of antiplatelet regimen d/t side effect
Measured: 1 year after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start15 Jan 2020
- Primary completion15 Jun 2021 (estimated)
- Study completion15 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 492 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gyeongsang National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- U&I Corporation
- Responsible party
- Sponsor
- Investigators
- Young-Hoon Jeong, MD, PhD, Principal investigator, Changwon Gyeongsang National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734353
- Sponsor's protocol ID
- E-5TION
- Acronym
- E-5TION
- Status last verified
- Jan 2021
- First submitted
- 18 Aug 2020
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31475799
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04734353
- Acronym / sponsor ID
- E-5TION / E-5TION
- Conditions
- Coronary Artery Disease
- Keywords
- High-risk coronary artery disease, Prasugrel, Ticagrelor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 492 participants (estimated)
- Lead sponsor
- Gyeongsang National University HospitalUniversity, hospital or other
- Collaborators
- U&I Corporation
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E5 group | Experimental | Drug: Prasugrel 5mgEscalation in CHIP |
| T60 group | Active comparator | Drug: Ticagrelor 60mgEscalation in CHIP |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prasugrel 5mgAlso: EffientPrasugrel 20 mg loading, followed by prasugrel 5 mg/day for 12 months | Drug | E5 group |
| Ticagrelor 60mgAlso: BrillintaTicagrelor 120 mg loading, followed by ticagrelor 60 mg bid for 12 months | Drug | T60 group |
Primary outcome
Major bleeding and adherence to DAPT regimen
Time frame: 1 year after PCI
Incidence of major bleeding (BARC type 2, 3 or 5) and prevalence of discontinuation/switch of antiplatelet regimen
4 secondary outcomes
MACE
Time frame: 1 year after PCI
Major bleeding
Time frame: 1 year after PCI
Major bleeding
Time frame: 1 year post-PCI
Adherence to DAPT regimen
Time frame: 1 year after PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Results publication: PubMed 31475799Schupke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Hoon Jeong, MD, PhD principal investigator
Changwon Gyeongsang National University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prasugrel 5mg and Ticagrelor 60mg in people with Coronary Artery Disease, run by Gyeongsang National University Hospital at 8 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Young-Hoon Jeong, MD, PhD (82-55-214-3721, goodoctor@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major bleeding and adherence to DAPT regimen (time frame: 1 year after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04734353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.