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| Name | Class |
|---|---|
| U&I Corporation | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E5 group | Experimental | Escalation in CHIP |
|
| T60 group | Active Comparator | Escalation in CHIP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasugrel 5mg | Drug | Prasugrel 20 mg loading, followed by prasugrel 5 mg/day for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| MACE | Incidence of MACE (CV death, myocardial infarction, stent thrombosis, stroke or urgent revascularization) | 1 year after PCI |
| Major bleeding | Incidence of BARC type 2, 3 or 5 bleeding |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet function test | VerifyNow PRU | 1 month after PCI |
| Bleeding assessment | Assessment of BARC bleeding based on dedicated bleeding questionnaire |
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young-Hoon Jeong, MD, PhD | Contact | 82-55-214-3721 | goodoctor@naver.com | |
| Jong-Hwa Ahn, MD, PhD | Contact | 82-55-214-3724 | jonghwaahn@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Young-Hoon Jeong, MD, PhD | Changwon Gyeongsang National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gyeongsang National University Changwon Hospital | Recruiting | Changwon | Gyeongsangnam-do | 51472 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31475799 | Result | 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. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
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| Ticagrelor 60mg | Drug | Ticagrelor 120 mg loading, followed by ticagrelor 60 mg bid for 12 months |
|
|
| 1 year after PCI |
| Major bleeding | Incidence of ISTH major bleeding or clinically relevant non-major (CRNM) bleeding | 1 year post-PCI |
| Adherence to DAPT regimen | Prevalence of discontinuation/switch of antiplatelet regimen d/t side effect | 1 year after PCI |
| 1 month after PCI |
| Dyspnea assessment | Assessment of dyspnea based on dedicated dyspnea questionnaire | 1 month after PCI |
| Gyeongsang National University Hospita | Recruiting | Jinju | Gyeongsangnam-do | South Korea |
|
| Pusan National University Yangsan Hospital | Recruiting | Yangsan | Gyeongsangnam-do | 626-770 | South Korea |
|
| Kosin University Gospel Hospital | Not yet recruiting | Busan | 602-702 | South Korea |
|
| Dong-A University Hospital | Not yet recruiting | Busan | 602-714 | South Korea |
|
| Pusan National University Hospital, | Not yet recruiting | Busan | 602-739, | South Korea |
|
| Inje University Busan Paik Hospital, | Not yet recruiting | Busan | South Korea |
|
| Ulsan University Hospital | Not yet recruiting | Ulsan | South Korea |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |