Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention

Summary

The purpose of this study is to compare the use of ticagrelor alone versus ticagrelor and aspirin together. Both ticagrelor and aspirin stop platelets from sticking together and forming a blood clot that could block blood flow to the heart. This study will look to determine the effectiveness and safety of ticagrelor alone, compared to ticagrelor plus aspirin in reducing clinically relevant bleeding and in reducing ischemic adverse events among high-risk patients who have had a percutaneous intervention with at least one drug-eluting stent. A patient is considered high-risk if they meet certain clinical and/or anatomic criteria. Up to 9000 subjects will be enrolled at the time of their index PCI. Subjects meeting randomization eligibility criteria at 3 months post enrollment will be randomized to either ticagrelor plus aspirin or ticagrelor plus placebo for an additional 12 months. Follow-up clinic visits will be performed at 3 months, 9 months and 15 months post enrollment.

Timeline

Start

2015-07

Primary completion

2019-07-10

Completion

2019-07-10

Publications

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• Background Jernberg T, Payne CD, Winters KJ, Darstein C, Brandt JT, Jakubowski JA, Naganuma H, Siegbahn A, Wallentin L. Prasugrel achieves greater inhibition of platelet aggregation and a lower rate of non-responders compared with clopidogrel in aspirin-treated patients with stable coronary artery disease. Eur Heart J. 2006 May;27(10):1166-73. doi: 10.1093/eurheartj/ehi877. Epub 2006 Apr 18.
• Background Wallentin L, Varenhorst C, James S, Erlinge D, Braun OO, Jakubowski JA, Sugidachi A, Winters KJ, Siegbahn A. Prasugrel achieves greater and faster P2Y12receptor-mediated platelet inhibition than clopidogrel due to more efficient generation of its active metabolite in aspirin-treated patients with coronary artery disease. Eur Heart J. 2008 Jan;29(1):21-30. doi: 10.1093/eurheartj/ehm545. Epub 2007 Nov 30.
• Background Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM; TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007 Nov 15;357(20):2001-15. doi: 10.1056/NEJMoa0706482. Epub 2007 Nov 4.
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• Background Husted S, Emanuelsson H, Heptinstall S, Sandset PM, Wickens M, Peters G. Pharmacodynamics, pharmacokinetics, and safety of the oral reversible P2Y12 antagonist AZD6140 with aspirin in patients with atherosclerosis: a double-blind comparison to clopidogrel with aspirin. Eur Heart J. 2006 May;27(9):1038-47. doi: 10.1093/eurheartj/ehi754. Epub 2006 Feb 13.
• Background Storey RF, Husted S, Harrington RA, Heptinstall S, Wilcox RG, Peters G, Wickens M, Emanuelsson H, Gurbel P, Grande P, Cannon CP. Inhibition of platelet aggregation by AZD6140, a reversible oral P2Y12 receptor antagonist, compared with clopidogrel in patients with acute coronary syndromes. J Am Coll Cardiol. 2007 Nov 6;50(19):1852-6. doi: 10.1016/j.jacc.2007.07.058. Epub 2007 Oct 23.
• Background Alexopoulos D, Galati A, Xanthopoulou I, Mavronasiou E, Kassimis G, Theodoropoulos KC, Makris G, Damelou A, Tsigkas G, Hahalis G, Davlouros P. Ticagrelor versus prasugrel in acute coronary syndrome patients with high on-clopidogrel platelet reactivity following percutaneous coronary intervention: a pharmacodynamic study. J Am Coll Cardiol. 2012 Jul 17;60(3):193-9. doi: 10.1016/j.jacc.2012.03.050.
• Background Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
• Background Baber U, Mehran R, Sharma SK, Brar S, Yu J, Suh JW, Kim HS, Park SJ, Kastrati A, de Waha A, Krishnan P, Moreno P, Sweeny J, Kim MC, Suleman J, Pyo R, Wiley J, Kovacic J, Kini AS, Dangas GD. Impact of the everolimus-eluting stent on stent thrombosis: a meta-analysis of 13 randomized trials. J Am Coll Cardiol. 2011 Oct 4;58(15):1569-77. doi: 10.1016/j.jacc.2011.06.049. Epub 2011 Sep 14.
• Background Feres F, Costa RA, Abizaid A, Leon MB, Marin-Neto JA, Botelho RV, King SB 3rd, Negoita M, Liu M, de Paula JE, Mangione JA, Meireles GX, Castello HJ Jr, Nicolela EL Jr, Perin MA, Devito FS, Labrunie A, Salvadori D Jr, Gusmao M, Staico R, Costa JR Jr, de Castro JP, Abizaid AS, Bhatt DL; OPTIMIZE Trial Investigators. Three vs twelve months of dual antiplatelet therapy after zotarolimus-eluting stents: the OPTIMIZE randomized trial. JAMA. 2013 Dec 18;310(23):2510-22. doi: 10.1001/jama.2013.282183.
• Background Valgimigli M, Campo G, Monti M, Vranckx P, Percoco G, Tumscitz C, Castriota F, Colombo F, Tebaldi M, Fuca G, Kubbajeh M, Cangiano E, Minarelli M, Scalone A, Cavazza C, Frangione A, Borghesi M, Marchesini J, Parrinello G, Ferrari R; Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study (PRODIGY) Investigators. Short- versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial. Circulation. 2012 Apr 24;125(16):2015-26. doi: 10.1161/CIRCULATIONAHA.111.071589. Epub 2012 Mar 21.
• Background Brar SS, Kim J, Brar SK, Zadegan R, Ree M, Liu IL, Mansukhani P, Aharonian V, Hyett R, Shen AY. Long-term outcomes by clopidogrel duration and stent type in a diabetic population with de novo coronary artery lesions. J Am Coll Cardiol. 2008 Jun 10;51(23):2220-7. doi: 10.1016/j.jacc.2008.01.063.
• Background Gwon HC, Hahn JY, Park KW, Song YB, Chae IH, Lim DS, Han KR, Choi JH, Choi SH, Kang HJ, Koo BK, Ahn T, Yoon JH, Jeong MH, Hong TJ, Chung WY, Choi YJ, Hur SH, Kwon HM, Jeon DW, Kim BO, Park SH, Lee NH, Jeon HK, Jang Y, Kim HS. Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) randomized, multicenter study. Circulation. 2012 Jan 24;125(3):505-13. doi: 10.1161/CIRCULATIONAHA.111.059022. Epub 2011 Dec 16.
• Background Chirumamilla AP, Maehara A, Mintz GS, Mehran R, Kanwal S, Weisz G, Hassanin A, Hakim D, Guo N, Baber U, Pyo R, Moses JW, Fahy M, Kovacic JC, Dangas GD. High platelet reactivity on clopidogrel therapy correlates with increased coronary atherosclerosis and calcification: a volumetric intravascular ultrasound study. JACC Cardiovasc Imaging. 2012 May;5(5):540-9. doi: 10.1016/j.jcmg.2011.12.019.
• Background Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
• Background Wiviott SD, Antman EM, Gibson CM, Montalescot G, Riesmeyer J, Weerakkody G, Winters KJ, Warmke JW, McCabe CH, Braunwald E; TRITON-TIMI 38 Investigators. Evaluation of prasugrel compared with clopidogrel in patients with acute coronary syndromes: design and rationale for the TRial to assess Improvement in Therapeutic Outcomes by optimizing platelet InhibitioN with prasugrel Thrombolysis In Myocardial Infarction 38 (TRITON-TIMI 38). Am Heart J. 2006 Oct;152(4):627-35. doi: 10.1016/j.ahj.2006.04.012.
• Background Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.
• Background Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Katus HA, Lindahl B, Morrow DA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S. Third universal definition of myocardial infarction. Circulation. 2012 Oct 16;126(16):2020-35. doi: 10.1161/CIR.0b013e31826e1058. Epub 2012 Aug 24. No abstract available.
• Steg PG, Nicolas J, Baber U, Sartori S, Zhang Z, Feng Y, Angiolillo DJ, Briguori C, Cohen DJ, Collier T, Dangas G, Dudek D, Escaned J, Gibson CM, Han YL, Huber K, Kastrati A, Kaul U, Marx SO, Kornowski R, Kunadian V, Vogel B, Oliva A, Mehta SR, Moliterno D, Sardella G, Krucoff M, Shlofmitz RA, Sharma S, Pocock S, Mehran R. Characterizing high-risk enrollment criteria and impact on clinical outcomes in a large randomized clinical trial: Insights from the TWILIGHT trial. Am Heart J. 2025 Aug;286:97-107. doi: 10.1016/j.ahj.2025.01.016. Epub 2025 Jan 30.
• Krucoff M, Spirito A, Baber U, Sartori S, Angiolillo DJ, Briguori C, Cohen DJ, Collier T, Dangas G, Dudek D, Escaned J, Gibson CM, Han YL, Huber K, Kastrati A, Kaul U, Kornowski R, Kunadian V, Vogel B, Mehta SR, Moliterno D, Sardella G, Shlofmitz RA, Sharma S, Steg PG, Pocock S, Mehran R. Ticagrelor with or without aspirin following percutaneous coronary intervention in high-risk patients with concomitant peripheral artery disease: A subgroup analysis of the TWILIGHT randomized clinical trial. Am Heart J. 2024 Jun;272:11-22. doi: 10.1016/j.ahj.2024.03.002. Epub 2024 Mar 6.
• Baber U, Spirito A, Sartori S, Angiolillo DJ, Briguori C, Cohen DJ, Collier T, Dangas G, Dudek D, Escaned J, Gibson CM, Han YL, Huber K, Kastrati A, Kaul U, Kornowski R, Krucoff M, Kunadian V, Vogel B, Mehta SR, Moliterno D, Sardella G, Shlofmitz RA, Sharma S, Steg PG, Pocock S, Mehran R. Clinically Driven Revascularization in High-Risk Patients Treated With Ticagrelor Monotherapy After PCI: Insights from the Randomized TWILIGHT Trial. Am J Cardiol. 2023 Dec 1;208:16-24. doi: 10.1016/j.amjcard.2023.09.008. Epub 2023 Oct 6.
• Mendieta G, Mehta S, Baber U, Angiolillo DJ, Briguori C, Cohen D, Collier T, Dangas G, Dudek D, Escaned J, Gil R, Vogel B, Cao D, Spirito A, Huber K, Kastrati A, Kaul U, Kornowski R, Krucoff MW, Kunadian V, Moliterno DJ, Ohman EM, Sardella G, Sartori S, Sharma S, Shlofmitz R, Steg PG, Han YL, Pocock S, Gibson CM, Mehran R. Bleeding and Ischemic Risks of Ticagrelor Monotherapy After Coronary Interventions. J Am Coll Cardiol. 2023 Aug 22;82(8):687-700. doi: 10.1016/j.jacc.2023.05.062.
• Spirito A, Koh WJ, Sartori S, Vogel B, Feng Y, Baber U, Nicolas J, Snyder C, Kamaleldin K, Pileggi B, Rezvanizadeh V, Sweeny J, Sharma SK, Kini A, Pocock SJ, Dangas G, Mehran R. Fatal, ischemic and bleeding risk of patients meeting the selection criteria of the TWILIGHT trial: Insights from a large PCI registry. Am Heart J. 2023 Sep;263:26-34. doi: 10.1016/j.ahj.2023.04.007. Epub 2023 Apr 23.
• Spirito A, Kastrati A, Cao D, Baber U, Sartori S, Angiolillo DJ, Briguori C, Cohen DJ, Dangas G, Dudek D, Escaned J, Gibson CM, Zhang Z, Huber K, Kaul U, Kornowski R, Kunadian V, Han YL, Mehta SR, Sardella G, Sharma S, Shlofmitz RA, Vogel B, Collier T, Pocock S, Mehran R. Ticagrelor with or without aspirin in high-risk patients with anaemia undergoing percutaneous coronary intervention: a subgroup analysis of the TWILIGHT trial. Eur Heart J Cardiovasc Pharmacother. 2023 Jun 2;9(4):328-336. doi: 10.1093/ehjcvp/pvad006.
• Han Y, Claessen BE, Chen SL, Chunguang Q, Zhou Y, Xu Y, Hailong L, Chen J, Qiang W, Zhang R, Luo S, Li Y, Zhu J, Zhao X, Cheng X, Wang J, Su X, Tao J, Sun Y, Wang G, Li Y, Bian L, Goel R, Sartori S, Zhang Z, Angiolillo DJ, Cohen DJ, Gibson CM, Kastrati A, Krucoff M, Mehta SR, Ohman EM, Steg PG, Liu Y, Dangas G, Sharma S, Baber U, Mehran R. Ticagrelor With or Without Aspirin in Chinese Patients Undergoing Percutaneous Coronary Intervention: A TWILIGHT China Substudy. Circ Cardiovasc Interv. 2022 Apr;15(4):e009495. doi: 10.1161/CIRCINTERVENTIONS.120.009495. Epub 2022 Mar 23.
• Chiarito M, Baber U, Cao D, Sharma SK, Dangas G, Angiolillo DJ, Briguori C, Cohen DJ, Dudek D, Dzavik V, Escaned J, Gil R, Hamm CW, Henry T, Huber K, Kastrati A, Kaul U, Kornowski R, Krucoff M, Kunadian V, Mehta SR, Moliterno D, Ohman EM, Oldroyd K, Sardella G, Zhongjie Z, Sartori S, Stefanini G, Shlofmitz R, Steg PG, Weisz G, Witzenbichler B, Han YL, Pocock S, Gibson CM, Mehran R. Ticagrelor Monotherapy After PCI in High-Risk Patients With Prior MI: A Prespecified TWILIGHT Substudy. JACC Cardiovasc Interv. 2022 Feb 14;15(3):282-293. doi: 10.1016/j.jcin.2021.11.005. Epub 2022 Jan 12.
• Vogel B, Baber U, Cohen DJ, Sartori S, Sharma SK, Angiolillo DJ, Farhan S, Goel R, Zhang Z, Briguori C, Collier T, Dangas G, Dudek D, Escaned J, Gil R, Han YL, Kaul U, Kornowski R, Krucoff MW, Kunadian V, Mehta SR, Moliterno D, Ohman EM, Sardella G, Witzenbichler B, Gibson CM, Pocock S, Huber K, Mehran R. Sex Differences Among Patients With High Risk Receiving Ticagrelor With or Without Aspirin After Percutaneous Coronary Intervention: A Subgroup Analysis of the TWILIGHT Randomized Clinical Trial. JAMA Cardiol. 2021 Sep 1;6(9):1032-1041. doi: 10.1001/jamacardio.2021.1720.
• Baber U, Dangas G, Angiolillo DJ, Cohen DJ, Sharma SK, Nicolas J, Briguori C, Cha JY, Collier T, Dudek D, Dzavik V, Escaned J, Gil R, Gurbel P, Hamm CW, Henry T, Huber K, Kastrati A, Kaul U, Kornowski R, Krucoff M, Kunadian V, Marx SO, Mehta S, Moliterno D, Ohman EM, Oldroyd K, Sardella G, Sartori S, Shlofmitz R, Steg PG, Weisz G, Witzenbichler B, Han YL, Pocock S, Gibson CM, Mehran R. Ticagrelor alone vs. ticagrelor plus aspirin following percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes: TWILIGHT-ACS. Eur Heart J. 2020 Oct 1;41(37):3533-3545. doi: 10.1093/eurheartj/ehaa670.
• Dangas G, Baber U, Sharma S, Giustino G, Mehta S, Cohen DJ, Angiolillo DJ, Sartori S, Chandiramani R, Briguori C, Dudek D, Escaned J, Huber K, Collier T, Kornowski R, Kunadian V, Kaul U, Oldroyd K, Sardella G, Shlofmitz R, Witzenbichler B, Ya-Ling H, Pocock S, Gibson CM, Mehran R. Ticagrelor With or Without Aspirin After Complex PCI. J Am Coll Cardiol. 2020 May 19;75(19):2414-2424. doi: 10.1016/j.jacc.2020.03.011. Epub 2020 Mar 30.
• Angiolillo DJ, Baber U, Sartori S, Briguori C, Dangas G, Cohen DJ, Mehta SR, Gibson CM, Chandiramani R, Huber K, Kornowski R, Weisz G, Kunadian V, Oldroyd KG, Ya-Ling H, Kaul U, Witzenbichler B, Dudek D, Sardella G, Escaned J, Sharma S, Shlofmitz RA, Collier T, Pocock S, Mehran R. Ticagrelor With or Without Aspirin in High-Risk Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention. J Am Coll Cardiol. 2020 May 19;75(19):2403-2413. doi: 10.1016/j.jacc.2020.03.008. Epub 2020 Mar 30.
• Mehran R, Baber U, Sharma SK, Cohen DJ, Angiolillo DJ, Briguori C, Cha JY, Collier T, Dangas G, Dudek D, Dzavik V, Escaned J, Gil R, Gurbel P, Hamm CW, Henry T, Huber K, Kastrati A, Kaul U, Kornowski R, Krucoff M, Kunadian V, Marx SO, Mehta SR, Moliterno D, Ohman EM, Oldroyd K, Sardella G, Sartori S, Shlofmitz R, Steg PG, Weisz G, Witzenbichler B, Han YL, Pocock S, Gibson CM. Ticagrelor with or without Aspirin in High-Risk Patients after PCI. N Engl J Med. 2019 Nov 21;381(21):2032-2042. doi: 10.1056/NEJMoa1908419. Epub 2019 Sep 26.

Drugs

Indications