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| Name | Class |
|---|---|
| Biotronik SE & Co. KG | INDUSTRY |
| Samjin Pharmaceutical Co., Ltd. | INDUSTRY |
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DAPT de-escalation strategies to reduce bleeding include de-escalation of DAPT intensity (downgrading from potent P2Y12 inhibitor at conventional doses to either clopidogrel or reduced-dose prasugrel) or abbreviation of DAPT duration. The EASTYLE trial will evaluate a hybrid DAPT de-escalation strategy (reduced-dose ticagrelor, followed by aspirin early discontinuation) in AMI patients, compared with a conventional DAPT strategy.
In ACS patients undergoing percutaneous coronary intervention, conventional dual antiplatelet therapy (DAPT) for patients with acute coronary syndromes undergoing percutaneous coronary intervention comprises aspirin with a potent P2Y12 inhibitor (prasugrel or ticagrelor) for 12 months. Although this approach reduces ischaemic risk, patients are exposed to a substantial risk of bleeding during the stabilized period. Strategies to reduce bleeding include de-escalation of DAPT intensity (downgrading from potent P2Y12 inhibitor at conventional doses to either clopidogrel or reduced-dose prasugrel) or abbreviation of DAPT duration. Abbreviation of DAPT duration after 1-6 months, followed by monotherapy with aspirin or a P2Y12 inhibitor, reduces bleeding without an increase in ischaemic events in patients at high bleeding risk, particularly those without high ischaemic risk. Either strategy requires assessment of the ischaemic and bleeding risks of each individual. Previous clinical and laboratory evidence demonstrates that a conventional-dose of ticagrelor has a potent antiplatelet effect, which appears to have a potential to increase the risk of bleeding during the stabilized period. Adjunctive use of aspirin to P2Y12 inhibitor would be important to protect the risk of thrombotic events in AMI patients, which use has a limited benefit with increased bleeding rate during the the stabilized period.
The EASTYLE trial will evaluate clinical benefit of step-down de-escalation DAPT strategy including downgrading of P2Y12 inhibition (from 90 mg to 60 mg ticagrelor at 1 month post-PCI) and abbreviation of DAPT duration (aspirin discontinuation at 3 months post-PCI), compared with a conventional DAPT strategy in AMI patients. This trial will support that the optimal platelet inhibition would be attenuated over time even in AMI patients. The result will make a big step toward precision medicine in the field of antiplatelet treatment in AMI patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| De-escalation strategy | Experimental | PCI ~ 1 month: ticagrelor 90 mg twice daily + aspirin 100 mg once daily 1 ~ 3 months: ticagrelor 60 mg twice daily + aspirin 100 mg once daily 3 ~ 12 months: ticagrelor 60 mg twice daily |
|
| Conventional strategy | Active Comparator | PCI ~ 12 months: ticagrelor 90 mg twice daily + aspirin 100 mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| De-escalation strategy | Drug | De-escalation strategy indicates conventional DAPT (ticagrelor 90 mg twice daily + aspirin 100 mg once daily) for 1 month, followed by de-escalation DAPT (ticagrelor 60 mg twice daily + aspirin 100 mg once daily) between 1 and 3 months. Between 3 and 12 months, patients will be treated with ticagrelor monotherapy (ticagrelor 60 mg twice daily). |
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint (NACE) | MACCE (all-cause death, non-fatal myocardial infarction, stent thrombosis or non-fatal stroke) + major bleeding (BARC type 2, 3, or 5 bleeding) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac and cerebrovascular events (MACCE) | all-cause death, non-fatal myocardial infarction, stent thrombosis or non-fatal stroke | 12 months |
| Bleeding events | BARC type 2, 3 or 5 bleeding; BARC 3 or 5 bleeding; TIMI major or minor bleeding; GUSTO severe or moderate bleeding; ISTH major bleeding |
| Measure | Description | Time Frame |
|---|---|---|
| Type of AMI | STEMI vs. NSTEMI | 12 months |
| HBR | presence of HBR (high bleeding risk) criteria | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moo Hyun Kim, MD, PhD | Contact | +82-51-240-2976 | kimmh@dau.ac.kr | |
| Young-Hoon Jeong, MD, PhD | Contact | +82-2-2610-6795 | goodoctor@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| Moo Hyun Kim, MD, PhD | Dong-A University Hospital, Busan, Republic of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DongA University Hospital | Recruiting | Busan | 602-715 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26376600 | Result | Goto S, Huang CH, Park SJ, Emanuelsson H, Kimura T. Ticagrelor vs. clopidogrel in Japanese, Korean and Taiwanese patients with acute coronary syndrome -- randomized, double-blind, phase III PHILO study. Circ J. 2015;79(11):2452-60. doi: 10.1253/circj.CJ-15-0112. Epub 2015 Sep 16. | |
| 28810251 | Result | Jin C, Kim MH, Bang J, Serebruany V. A Prospective, Randomized, Open-Label, Blinded, Endpoint Study Exploring Platelet Response to Half-Dose Prasugrel and Ticagrelor in Patients with the Acute Coronary Syndrome: HOPE-TAILOR Study. Cardiology. 2017;138(4):201-206. doi: 10.1159/000478000. Epub 2017 Aug 16. |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| C028145 | 2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
|
| Conventional strategy | Drug | Conventional stratetgy indicates conventional DAPT including ticagrelor 90 mg twice daily and aspirin 100 mg once daily during 12 months. |
|
|
| 12 months |
| All-cause death | any mortality | 12 months |
| CV death | Death related CV system | 12 months |
| MI | Myocardial infarction | 12 months |
| Stent thrombosis | definite or probable stent thrombosis by Academic Research Consortium (ARC) definition | 12 months |
| Ischemic stroke | Stroke | 12 months |
| Cardiac death, or MI | Coronary thrombotic events | 12 months |
| Cardiac death, MI or stent thrombosis | Coronary thrombotic events | 12 months |
| Cardiovascular death, MI or stroke | MACE | 12 months |
| TLR | target lesion revascularization | 12 months |
| TVR | target vessel revascularization | 12 months |
| Any revascularization | Re-PCI during follow-up | 12 months |
| DM | presence of diabetes mellitus | 12 months |
| CKD | presence of chronic kidney disease | 12 months |
| Anemia | presence of anemia | 12 months |
| Gender | Male vs. female | 12 months |
| Age | Old vs. young age (65 yo, 75 yo) | 12 months |
| Complex PCI | Presence of complex PCI | 12 months |
| GDMT | Presence of guideline-directed medical therapy | 12 months |
| Type of statin | Rosuvastatin vs. other statins | 12 months |
| CHF | Presence of congestive heart failure | 12 months |
| PAD | Presence of peripheral artery disease | 12 months |
| PFT | VerifyNow assy | 12 months |
| Predictors of MACCE | Clinical impact of de-esclation strategy on MACCE | 12 months |
| Predictors of maor bleeding | Clinical impact of de-esclation strategy on major bleeding | 12 months |
| 37474795 | Result | Gorog DA, Ferreiro JL, Ahrens I, Ako J, Geisler T, Halvorsen S, Huber K, Jeong YH, Navarese EP, Rubboli A, Sibbing D, Siller-Matula JM, Storey RF, Tan JWC, Ten Berg JM, Valgimigli M, Vandenbriele C, Lip GYH. De-escalation or abbreviation of dual antiplatelet therapy in acute coronary syndromes and percutaneous coronary intervention: a Consensus Statement from an international expert panel on coronary thrombosis. Nat Rev Cardiol. 2023 Dec;20(12):830-844. doi: 10.1038/s41569-023-00901-2. Epub 2023 Jul 20. |
| 37072035 | Result | Gorog DA, Jeyalan V, Markides RIL, Navarese EP, Jeong YH, Farag M. Comparison of De-escalation of DAPT Intensity or Duration in East Asian and Western Patients with ACS Undergoing PCI: A Systematic Review and Meta-analysis. Thromb Haemost. 2023 Aug;123(8):773-792. doi: 10.1055/s-0043-57030. Epub 2023 Apr 18. |
| 36578832 | Result | Kang MG, Ahn JH, Kim K, Koh JS, Park JR, Hwang SJ, Park Y, Tantry US, Gurbel PA, Hwang JY, Jeong YH. Prevalence of adverse events during ticagrelor versus clopidogrel treatment and its association with premature discontinuation of dual antiplatelet therapy in East Asian patients with acute coronary syndrome. Front Cardiovasc Med. 2022 Dec 12;9:1053867. doi: 10.3389/fcvm.2022.1053867. eCollection 2022. |
| 34622433 | Result | Kubica J, Adamski P, Gorog DA, Kubica A, Jilma B, Budaj A, Siller-Matula JM, Gurbel PA, Alexopoulos D, Badariene J, Dabrowski P, Dudek D, Giannitsis E, Horszczaruk G, Jaguszewski MJ, James S, Jeong YH, Kryjak M, Niezgoda P, Ostrowska M, Patti G, Romanek J, Di Somma S, Specchia G, Tantry U, Gasior M, Tycinska A, Wojakowski W, Buszko K, Gil R, Gruchala M, Kasprzak J, Kleinrok A, Legutko J, Lesiak M, Navarese EP. Low-dose ticagrelor with or without acetylsalicylic acid in patients with acute coronary syndrome: Rationale and design of the ELECTRA-SIRIO 2 trial. Cardiol J. 2022;29(1):148-153. doi: 10.5603/CJ.a2021.0118. Epub 2021 Oct 8. No abstract available. |
| 33802015 | Result | Kim L, Choe JC, Ahn JH, Lee HW, Oh JH, Choi JH, Lee HC, Cha KS, Hong TJ, Jeong YH, Park JS. Temporal Trends of Bleeding Episodes during Half- vs. Standard-Dose Ticagrelor in Acute Coronary Syndrome Patients with Low Platelet Reactivity: A Randomized BLEEDING-ACS Trial. J Clin Med. 2021 Mar 10;10(6):1159. doi: 10.3390/jcm10061159. |
| 33171520 | Result | Kim HK, Tantry US, Smith SC Jr, Jeong MH, Park SJ, Kim MH, Lim DS, Shin ES, Park DW, Huo Y, Chen SL, Bo Z, Goto S, Kimura T, Yasuda S, Chen WJ, Chan M, Aradi D, Geisler T, Gorog DA, Sibbing D, Lip GYH, Angiolillo DJ, Gurbel PA, Jeong YH. The East Asian Paradox: An Updated Position Statement on the Challenges to the Current Antithrombotic Strategy in Patients with Cardiovascular Disease. Thromb Haemost. 2021 Apr;121(4):422-432. doi: 10.1055/s-0040-1718729. Epub 2020 Nov 10. |
| 33032710 | Result | Park Y, Koh JS, Lee JH, Park JH, Shin ES, Oh JH, Chun W, Lee SY, Bae JW, Kim JS, Kim W, Suh JW, Yang DH, Hong YJ, Chan MY, Kang MG, Park HW, Hwang SJ, Hwang JY, Ahn JH, Choi SW, Jeong YH; HEALING-AMI Investigators. Effect of Ticagrelor on Left Ventricular Remodeling in Patients With ST-Segment Elevation Myocardial Infarction (HEALING-AMI). JACC Cardiovasc Interv. 2020 Oct 12;13(19):2220-2234. doi: 10.1016/j.jcin.2020.08.007. |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |