Background: Patients with noncardioembolic ischemic stroke or transient ischemic attack (TIA) are at risk for recurrent stroke. Low factor XI levels are associated with a reduced risk of ischemic stroke. Asundexian inhibits activated factor XI. Whether the addition of asundexian to antiplatelet therapy would be superior to antiplatelet therapy alone for the secondary prevention of ischemic stroke is unclear.
Methods: In this phase 3, double-blind trial, we randomly assigned patients within 72 hours after the onset of a noncardioembolic ischemic stroke or high-risk TIA to receive asundexian (50 mg once daily) or placebo, in addition to planned dual or single antiplatelet therapy. Patients had at least one of the following: a nonlacunar infarct on imaging, a history of atherosclerosis, or evidence of atherosclerotic plaque at any location on cerebrovascular imaging. The primary efficacy outcome was ischemic stroke. The composite of death from cardiovascular causes, myocardial infarction, or stroke was a key secondary outcome. The primary safety outcome was major bleeding.
Results: Among 12,327 patients who underwent randomization (6162 to the asundexian group and 6165 to the placebo group), the incidence of ischemic stroke was lower in the asundexian group than in the placebo group (6.2% vs. 8.4%; cause-specific hazard ratio, 0.74; 95% confidence interval [CI], 0.65 to 0.84; P<0.001). The incidence of the composite of death from cardiovascular causes, myocardial infarction, or stroke was lower in the asundexian group than in the placebo group. The incidence of major bleeding was similar in the asundexian group and the placebo group (1.9% and 1.7%, respectively; cause-specific hazard ratio, 1.10; 95% CI, 0.85 to 1.44). The incidence of adverse events was 69.3% in the asundexian group and 70.1% in the placebo group; the incidence of serious adverse events was 19.2% and 19.5%, respectively.
Conclusions: Among patients with noncardioembolic ischemic stroke or high-risk TIA treated with antiplatelet therapy, asundexian at a daily dose of 50 mg resulted in lower risks of ischemic stroke and major cardiovascular events than placebo, without a higher risk of major bleeding.
Asundexian for Secondary Stroke Prevention / M, Sharma; Q, Dong; T, Hirano; Se, Kasner; Jl, Saver; J, Masjuan; Am, Demchuk; C, Cordonnier; D, Bereczki; G, Tsivgoulis; R, Veltkamp; I, Staikov; Hj, Bae; Bcv, Campbell; A, Zini; Ih, Lee; M, Kovar; R, Mikulik; R, Lemmens; Jm, Ferro; T, Robinson; H, Christensen; S, Ozturk; Rr, Leker; P, Turcani; A, Slowik; P, Amaya; Fk, Hoo; Marchis Gm, De; M, Knoflach; Pn, Sylaja; J, Putaala; Jm, Coutinho; Der Worp Hb, Van; E, Miglane; V, Matijošaitis; Ag, Lindgren; G, Sampaio Silva; Ec, Sandset; St, Turuspekova; P, Amarenco; Kn, Sheth; Ee, Smith; Jw, Eikelboom; Ra, Joundi; K, Schulze; L, Xu; L, Heenan; P, Colorado; L, Keller; E, Muehlhofer; C, Neumann; H, Mundl; A, Shoamanesh; Ameriso, Sf; Martín Artesi, Jj; Balian, N; Bruera, G; Cartasegna, L; Firstenfeld, A; Gonzalez, La; Ioli, P; Jure, L; Luraschi, A; Orzuza, G; Persi, Gg; Povedano, G; Romano, M; Anderson, C; Austin, D; Bailey, P; Boland-Freitas, R; Butcher, K; Campbell, Bcv; Chemmanam, T; Choi, P; Cloud, G; Cordato, D; Devlin, M; Dhakal, M; Esperon, Cg; Evans, S; Geraghty, R; Ghia, D; Grimley, R; Haque, S; Kleinig, T; Moey, A; Piechowski-Jozwiak, B; Priglinger-Coorey, M; Sahathevan, R; Singhal, S; Tryambake, D; Wijeratne, T; Wong, C; Bockstrucker, C; Kulyk, C; Ferrari, J; Gattringer, T; Greisenegger, S; Gruber, J; Knoflach, M; Lackner, P; Lampl, C; Matz, K; Oberndorfer, S; Werner, P; De Herdt, V; De La Meilluere, G; De Pauw, A; De Raedt, S; Desfontaines, P; Klippel, N; Lemmens, R; Ligot, N; Peeters, A; Siau, B; Vanacker, P; Vanhooren, G; Battaglini, M; Bazan, R; Bezerra, Dc; Boschim, L; Braga, Gp; Carbonera, La; Fernandes, Bfs; Lima, Fo; Martins, Sco; Meira, Fca; Minelli, C; Moro, C; Oliveira, J; Pontes, Om; Pupe, Ccb; Ramacciotti, E; Sampaio, G; Souza, Apa; Zelota, Vf; Andonova, V; Danovska, M; Dimitrova, M; Genov, K; Haralanov, L; Kalpachki, R; Kaprelyan, A; Koralova, A; Kostadinova, Y; Kralev, B; Milanova, M; Petrova, N; Prinova, K; Sotirov, N; Staikov, I; Tsvetanov, P; Vasileva, E; Beaudry, M; 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[10.1056/NEJMoa2513880]
Asundexian for Secondary Stroke Prevention
Sharma M; Dong Q; Hirano T; Kasner SE; Saver JL; Masjuan J; Demchuk AM; Cordonnier C; Bereczki D; Tsivgoulis G; Veltkamp R; Staikov I; Bae HJ; Campbell BCV; Zini A; Lee IH; Kovar M; Mikulik R; Lemmens R; Ferro JM; Robinson T; Christensen H; Ozturk S; Leker RR; Turcani P; Slowik A; Amaya P; Hoo FK; De Marchis GM; Knoflach M; Sylaja PN; Putaala J; Coutinho JM; van der Worp HB; Miglane E; Matijošaitis V; Lindgren AG; Sampaio Silva G; Sandset EC; Turuspekova ST; Amarenco P; Sheth KN; Smith EE; Eikelboom JW; Joundi RA; Schulze K; Xu L; Heenan L; Colorado P; Keller L; Muehlhofer E; Neumann C; Mundl H; Shoamanesh A; SF Ameriso; JJ Martín Artesi; N Balian; G Bruera; L Cartasegna; A Firstenfeld; LA Gonzalez; P Ioli; L Jure; A Luraschi; G Orzuza; GG Persi; G Povedano; M Romano; C Anderson; D Austin; P Bailey; R Boland-Freitas; K Butcher; BCV Campbell; T Chemmanam; P Choi; G Cloud; D Cordato; M Devlin; M Dhakal; CG Esperon; S Evans; R Geraghty; D Ghia; R Grimley; S Haque; T Kleinig; A Moey; B Piechowski-Jozwiak; M Priglinger-Coorey; R Sahathevan; S Singhal; D Tryambake; T Wijeratne; C Wong; C Bockstrucker; C Kulyk; J Ferrari; T Gattringer; S Greisenegger; J Gruber; M Knoflach; P Lackner; C Lampl; K Matz; S Oberndorfer; P Werner; V De Herdt; G De La Meilluere; A De Pauw; S De Raedt; P Desfontaines; N Klippel; R Lemmens; N Ligot; A Peeters; B Siau; P Vanacker; G Vanhooren; M Battaglini; R Bazan; DC Bezerra; L Boschim; GP Braga; LA Carbonera; BFS Fernandes; FO Lima; SCO Martins; FCA Meira; C Minelli; C Moro; J Oliveira; OM Pontes; CCB Pupe; E Ramacciotti; G Sampaio; APA Souza; VF Zelota; V Andonova; M Danovska; M Dimitrova; K Genov; L Haralanov; R Kalpachki; A Kaprelyan; A Koralova; Y Kostadinova; B Kralev; M Milanova; N Petrova; K Prinova; N Sotirov; I Staikov; P Tsvetanov; E Vasileva; M Beaudry; S Coutts; A Demchuk; A Deshmukh; B Durafourt; T Field; D Gladstone; J Gorman; B Graham; G Gubitz; M Horton; S Hu; R Joundi; R Lun; L Mai; J Mandzia; G Medvedev; F Moreau; A Moussaddy; A Muccilli; A Poppe; J Shankar; A Shuaib; N Singh; G Stotts; A Thiel; A Tkach; S Verreault; TR Winder; A Zafar; H Cai; W Cao; H Chen; D Deng; A Dong; Y Dong; Q Dong; W Fan; A Guo; C Guo; D Guo; J Guo; D Hong; R Hu; X Hu; L Huang; S Huang; P Jing; S Ke; D Liu; J Liu; Y Liu; H Lv; L Min; R Shen; W Shen; H Song; B Sun; X Sun; J Tan; T Tang; X Tian; C Wang; D Wang; F Wang; J Wang; L Wang; Q Wang; S Wang; Y Wang; X Wang; Z Wang; Y Wei; H Wu; J Wu; D Xu; F Yan; Z Yan; M Yang; X Ye; M Yu; W Yue; Y Yue; A Zhang; J Zhang; Q Zhang; R Zhang; H Zhao; P Amaya; E Arango; D M Barbosa; J Betancur; SU Callejas; IMP Castellanos; C Gallego; L Gomez; O Martinez; HCA Murcia; R Peñarete; M Quintero; JAN Ramos; G Sanchez; F Silva; D Vallejo; F Varon; J Vivas; LFR Wandurraga; M Bar; D Cernik; Z Eichlova; P Geier; M Harsany; D Hlinovsky; M Kovar; R Mikulik; J Neumann; J Rosol; O Skoda; M Sramek; I Stetkarova; R Sukop; D Vaclavik; K Aegidius; H Christensen; N Hjort; H Iversen; H Jensen; C Kruuse; B Modrau; B Sandal; AM Kantanen; J Putaala; S Roine; T Sarkanen; J Sipilä; Y Bejot; M Bataille; D Calvet; B Casolla; N Chausson; C Cordonnier; J D Dehondt; S D Bouard; C Denier; L Derex; E Doche; A Faivre; C Gollion; B Guillon; P Lavallee; MH Mahagne; A Malbranque; N Messauodi; S Moulin; T Moulin; M Obadia; M Pasi; M Pasquini; P Reiner; S Richard; C Rosso; I Sibon; E Thouvenot; S Timsit; C Tracol; D Weisenburger-Lile; V Wolff; K Althaus; J Berrouschot; J Damm; S Gerner; M Gliem; M Jünemann; B Kallmünzer; C Klingner; M Laible; J Lee; J Machetanz; L Marquardt; S Mueller; S Mundi; D Nabavi; S Paus; J Pelz; G Petzold; C Pohlmann; J Purrucker; J Röthe; J H Schaefer; R Schubert; B Sehm; T Siepmann; H Soda; C Strecker; T Uphaus; R Veltkamp; B von Sarnowski; K Weissenborn; E Dardiotis; I Ellul; V Gourbali; M Gryllia; M Ioakeimidis; T Karapanayiotides; D Kazis; A Kiamili; S Konitsiotis; V Kotsis; P Mitsias; A Safouris; T Tegos; S Triantafyllou; G Tsivgoulis; K Vadikolias; S Vassilopoulou; D Bereczki; A Csanyi; M Czurko; M Gottschal; A Hajas; P Klivenyi; S Nardai; L Nemeth; L Olah; G Panczel; C Rozsa; L Szapary; N Szegedi; G Timar; L Varannai; I Vastagh; A Agarwal; P J Alapatt; R Bhatia; S K Bhoi; J R Chaudhuri; S Desai; V Junewar; A Kumari; A Miraclin; G Nagamani; V Pamidimukkala; R Parthasathy C Pushpa; P Raja; TCR Ramakrishnan; A Sharma; S Singh; PN Sylaja; S Bloch; R Eichel; A Gelfand; C Granbichler; H Halevi; S Haratz; A Horev; Y Lampl; RR Leker; D Orion; S Peretz; G Raphaeli; S Sabetay; N Simaan; D Tanne; A Adami; V Andreone; L Barbarini; M Cappellari; V Caso; L Dambrosio; IL De Magistris; C Deluca; M Diomedi; G Frisullo; P La Spina; M Longoni; M Mannino; G Merlino; A Naldi; R Napoletano; P Nencini; M Paolucci; A Pezzini ;A Rizzo; L Roveri; S Sacco; M Sessa; R Tassi; T Tassinari; M Vedovello; G Viticchi; A Zini; H Aikawa; S Arakawa; K Asakura; H Fujigasaki; S Fukazawa; K Fukuyama; K Haraguchi; N Hashimoto; T Hata; T Hatano; M Hayasaka; T Hirano; N Hiyama; T Ichikawa; S Ishihara; K Ishii; T Iwanaga; T Izumidani; H Joki; C Kaneko; Y Kawamoto; M Kawanishi; H Kawano; T Kawasaki; H Koji; Y Kuga; K Kuroki; Y Kusano; M Kosugi; N Mabuchi; A Machida; N Maeda; H Masuda; K Matsuda; S Matsumoto; T Miyazaki; N Murai; T Nagao; Y Nakae; H Nakagawa J Nakagawa; K Nakagawa; S Nakano; N Nakao; M Obayashi; S Okazaki; H Onishi; K Ono; N Oshita; M Ozaki; M Sakaguchi; T Shimizu; A Shindo; K Sonoda; Y Sueda; H Sugimori; K Sumii; H Takaba; T Takada; N Takehiko; S Takenaka; M Takeuchi; W Taki; K Takizawa; K Tokunaga; H Tomimitsu; K Tsuto; T Uehara; T Umemura; K Wada; N Wada; W Mutsufusa; R Yako; T Yamada; H Yamagami; H Yamashita; K Yamauchi; M Yamazaki; D Yasutomi; Y Yazawa; Y Yoshida; M Yoshizawa; H Yuasa; G Kabdrakhmanova; A Kaysarbekova; S T Turuspekova; Z Danevica; I Ikerte; G Karelis; E Miglane; K Stirans; G Gumbrevicius; D Jatuzis; K Juknelis; A Kazlauskas; V Matijosaitis; A Vilionskis; Y K Chia; R I Hamid; S Halim; F K Hoo; M Husin; J N Keng; D Krishnan; W C Law; T M-L Sharon; S K Wong; J M Coutinho; H den Hertog; R Gons; W Jolink; J Kerklaan; W Moudrous; J Piet; T Schreuder; R van den Berg-Vos; B van der Worp; M van Zagten; SJ Aarli; K Kraglund; AH Morsund; M Nordhaug; OM Ronning; EC Sandset; YM Seljeseth; M Bilik; M Chorazy; L Darda-Ledzion; W Fryze; M Karliński; B Labuz-Roszak; A Lasek-Bal; M Masztalewicz; R Nowak; V Palacz-Duda; K Rejdak; A Slowik; A Stepien; E Araujo; P Canhão; P Castro; V Cruz; JM Ferro; C Frias; R Gouveia; C Machado; JP Marto; SH Nzwalo; AA Pinto; M Rodrigues; D Sá; R Varela; A Cvengrosova; M Dvorak; L Gurcik; G Hajas; M Kovacik; G Krastev; M Krivosik; E Kurca; M Kycina; B Lorincz; M Muzik; R Risnovsky; P Turcani; J Veverka; E Zacharova; H-J Bae; J K Cha; Y Hwang; K-S Hong; K Kang; CK Kim; E-G Kim; J-T Kim; J-S Koo; S Kwon; K Lee; S-H Lee; HS Nam; H Park; J-H Rha; W-K Seo; DI Shin; S Sohn; HG Woo; K-H Yu; S Yu; E Alvarez Rodriguez; J Alonso; J F Arenillas Lara; O Ayo-Martin; P Calleja Castano; P Camps Renom; P Cardona Portela; GM Capdevilla; M Castellanos; M Del Mar Freijo Guerrero; JM Fabregas; J Gonzalez Valcarcel; B F Gimeno; M Hernández Pérez; J C Martínez Ramos; J Masjuan; A Iglesias Mohedano; C Molina Cateriano; F Moniche Alvarez; AC Nunez; AM Ortiz; S Pérez Sánchez; AJ Ponz de Tienda; F Purroy García; M Rodriguez Yanez; Y Silva Bas; J Tejada; C Tejero Juste; J Tembl Ferrairo; S Trillo; X Ustrell; N Ahmed; AC Laska; AG Lindgren; J Ögren; L Sjöblom; P Redfors; M Romanitan; M Arnold; E Carrera; C Cereda; H Gensicke; G M De Marchis; J Fladt; G Kaegi; F Medlin; P Michel; N Peters; A Tarnutzer; C Akpinar; M M Atmaca; E Aytac; R Baydemir; H Bektas; IY Gencdal; IL Gungor; E Gurkas; C Isikay; I Midi; B Nazliel; AÖ Özdemir; S Ozturk; V Ozturk; H Sirin; O Tokgoz; M Topcuoglu; A Unal; N Yesilot; O Yildiz; Y Abousleiman; S Ankolekar; J Chembala; S Dima; S Elyas; T England; G Gunathilagan; T Hlaing; N Hunter; D Kalladka; J Kennedy; A Kishore; J Kubie; R Marigold; V Papavasileiou; T Quinn; T Robinson; N Sattar; AN Aghaebrahim; I Altafullah; C Amory; S Anandaram; S Aroor; A Arora; R Arora; C Banerjee; V Bansal; R Behrouz; P Bhattacharya; S Bokkala-Pinninti; G Bonnella; J Brorson; D Brown; T Casanova; D S Chaturvedi; A Chebl; R Cheung; N Chiota-McCollom; D Chiu; W Clark; J Cohen; M Concha; J Craig; D Cross; B Cucchiara; J Day; A de Havenon; C Deline; S Dofitas; F Esparza; FL Estofan; M Ezzeddine; A Ford; R Gonzalez; C Guardia; D Gulati; Q Hao; A Hassan; A Helms; Y Isayev; B Jacobs; V Javalkar; F Kaddouh; SE Kasner; O Kass-Hout; S Kaur; F Khan; N Khoury; E Kochert; M Kolikonda; A Lendaris; C Liang; S Levine; CW Logan; A Loochtan; JI Lopez; A Lord; T Lukovits; B Mac Grory; S Male; K Matmati; S Mayer; C McDonald; B Mehta; E Melkumova; S Mittal; N Mueller-Kronast; M Mullen; J Neal; P Nguyen; J Nomura; K Olds; S Onteddu; N Osteraas; K Parsha; N Patel; T Peng; C Perez; L Peruski; T Phinney; M Pursley; V Rao-Chintapally; D Ray; A Razak; S Renati; S Rudolph; A Russman; A Sangha; N Sangha; JL Saver; M Schneck; A Schneider; T Schoonover; A Schulman; P K Sethi; H Seol; M Shafie; T Shang; L Sharma; S Sheth; E Sidorov; G Simms; V Singh; N Singhal; S Sivakumar; R Taylor; F Testai; C Thurman; P Varelas; P Venkatachalam; J Willey; B Wiseman; P Wright; S Yaddanapudi; S Yaghi; O Zaidat; S Zaidi; R Zand; R Zweifler; L Chan; A-C Chao; A-C Chen; P-L Chen; S-H Chen; T-C Chen; Y C Cheng; C-H Chou; W-Y Huang; I-H Lee; Y-C Lee; L M Lien; C-H Lin; Y-J Lin; C-H Liu; Y Sun; P-S Sung; C-W Tang; S-C Tang; H-Y Weng; M-H Wu; T-H Yeh; M Sharma; A Shoamanesh; P Amarenco; S Ameriso; H-J Bae; S J Connolly; J Eikelboom; I-H Lee; E Muehlhofer; H Mundl; G Sampaio Silva; K Sheth; A Słowik; E E Smith; S Jones; S Al-Khatib; R Harrison; A Husain; L Jackson; A Katsanos; B Kolls; D Kong; R McGarrah; R Mehta; S Messe; M Morris; T Povsic; J Rymer; D Sahlas; C Sasannejad; N Shah; A Srivastava; R V Swaminathan; J Halperin; T Cook; S Greenberg; S Middeldorp; M Rubiera; M Ernst; J Gilbride; L Jenkins; M Lehrkamp; C Neumann; K Balasubramanian; S Bangdiwala; L Heenan; P Naresh Kumar; R Ahmed Rashed; K Schulze; O Shestakovska; L Xu; S Aman; S Block; C Linton; J Miller; Y Ou; M Randev; K Stefani; A Taylor; U Balasubramanian; V Camerini; P Colorado; A Dihlmann; K Gijselman; S Ives; L Keller; F Naretto; S Spieweg; N Sutar; T Tervomaa; R van Beers; I Damaude Ximinez.
2026-01-01
Abstract
Background: Patients with noncardioembolic ischemic stroke or transient ischemic attack (TIA) are at risk for recurrent stroke. Low factor XI levels are associated with a reduced risk of ischemic stroke. Asundexian inhibits activated factor XI. Whether the addition of asundexian to antiplatelet therapy would be superior to antiplatelet therapy alone for the secondary prevention of ischemic stroke is unclear.
Methods: In this phase 3, double-blind trial, we randomly assigned patients within 72 hours after the onset of a noncardioembolic ischemic stroke or high-risk TIA to receive asundexian (50 mg once daily) or placebo, in addition to planned dual or single antiplatelet therapy. Patients had at least one of the following: a nonlacunar infarct on imaging, a history of atherosclerosis, or evidence of atherosclerotic plaque at any location on cerebrovascular imaging. The primary efficacy outcome was ischemic stroke. The composite of death from cardiovascular causes, myocardial infarction, or stroke was a key secondary outcome. The primary safety outcome was major bleeding.
Results: Among 12,327 patients who underwent randomization (6162 to the asundexian group and 6165 to the placebo group), the incidence of ischemic stroke was lower in the asundexian group than in the placebo group (6.2% vs. 8.4%; cause-specific hazard ratio, 0.74; 95% confidence interval [CI], 0.65 to 0.84; P<0.001). The incidence of the composite of death from cardiovascular causes, myocardial infarction, or stroke was lower in the asundexian group than in the placebo group. The incidence of major bleeding was similar in the asundexian group and the placebo group (1.9% and 1.7%, respectively; cause-specific hazard ratio, 1.10; 95% CI, 0.85 to 1.44). The incidence of adverse events was 69.3% in the asundexian group and 70.1% in the placebo group; the incidence of serious adverse events was 19.2% and 19.5%, respectively.
Conclusions: Among patients with noncardioembolic ischemic stroke or high-risk TIA treated with antiplatelet therapy, asundexian at a daily dose of 50 mg resulted in lower risks of ischemic stroke and major cardiovascular events than placebo, without a higher risk of major bleeding.
Citazione
Asundexian for Secondary Stroke Prevention / M, Sharma; Q, Dong; T, Hirano; Se, Kasner; Jl, Saver; J, Masjuan; Am, Demchuk; C, Cordonnier; D, Bereczki; G, Tsivgoulis; R, Veltkamp; I, Staikov; Hj, Bae; Bcv, Campbell; A, Zini; Ih, Lee; M, Kovar; R, Mikulik; R, Lemmens; Jm, Ferro; T, Robinson; H, Christensen; S, Ozturk; Rr, Leker; P, Turcani; A, Slowik; P, Amaya; Fk, Hoo; Marchis Gm, De; M, Knoflach; Pn, Sylaja; J, Putaala; Jm, Coutinho; Der Worp Hb, Van; E, Miglane; V, Matijošaitis; Ag, Lindgren; G, Sampaio Silva; Ec, Sandset; St, Turuspekova; P, Amarenco; Kn, Sheth; Ee, Smith; Jw, Eikelboom; Ra, Joundi; K, Schulze; L, Xu; L, Heenan; P, Colorado; L, Keller; E, Muehlhofer; C, Neumann; H, Mundl; A, Shoamanesh; Ameriso, Sf; Martín Artesi, Jj; Balian, N; Bruera, G; Cartasegna, L; Firstenfeld, A; Gonzalez, La; Ioli, P; Jure, L; Luraschi, A; Orzuza, G; Persi, Gg; Povedano, G; Romano, M; Anderson, C; Austin, D; Bailey, P; Boland-Freitas, R; Butcher, K; Campbell, Bcv; Chemmanam, T; Choi, P; Cloud, G; 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Il report seguente simula gli indicatori relativi alla propria produzione scientifica in relazione alle soglie ASN 2023-2025 del proprio SC/SSD. Si ricorda che il superamento dei valori soglia (almeno 2 su 3) è requisito necessario ma non sufficiente al conseguimento dell'abilitazione.
