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3. Bleeding risk prediction in patients treated with antithrombotics according to site of bleeding, indication for treatment and time since initiation

Author

Bhagirath, Vinai, additional, Kovalova, Tanya, additional, Wang, Jia Steven, additional, Xu, Lizhen, additional, Bangdiwala, Shrikant, additional, O'Donnell, Martin, additional, Shoamanesh, Ashkan, additional, Bosch, Jackie, additional, Coppolecchia, Rosa, additional, Vaitsiakhovich, Tatsiana, additional, Kleinjung, Frank, additional, Mundl, Hardi, additional, and Eikelboom, John W, additional

Published
2024
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4. Bleeding Outcomes in Patients Treated With Asundexian in Phase II Trials

Author

Eikelboom, John W., primary, Mundl, Hardi, additional, Alexander, John H., additional, Caso, Valeria, additional, Connolly, Stuart J., additional, Coppolecchia, Rosa, additional, Gebel, Martin, additional, Hart, Robert G., additional, Holberg, Gerlind, additional, Keller, Lars, additional, Patel, Manesh R., additional, Piccini, Jonathan P., additional, Rao, Sunil V., additional, Shoamanesh, Ashkan, additional, Tamm, Miriam, additional, Viethen, Thomas, additional, Yassen, Ashraf, additional, and Bonaca, Marc P., additional

Published
2024
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7. A Multicenter, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Finding Trial of the Oral Factor XIa Inhibitor Asundexian to Prevent Adverse Cardiovascular Outcomes After Acute Myocardial Infarction

Author

Rao, Sunil V., primary, Kirsch, Bodo, additional, Bhatt, Deepak L., additional, Budaj, Andrzej, additional, Coppolecchia, Rosa, additional, Eikelboom, John, additional, James, Stefan K., additional, Jones, W. Schuyler, additional, Merkely, Bela, additional, Keller, Lars, additional, Hermanides, Renicus S., additional, Campo, Gianluca, additional, Ferreiro, José Luis, additional, Shibasaki, Taro, additional, Mundl, Hardi, additional, Alexander, John H., additional, Hengstenberg, Christian, additional, Steinwender, Clemens, additional, Alber, Hannes, additional, Steringer-Mascherbauer, Regina, additional, Schober, Andreas, additional, Auer, Johann, additional, Roithinger, Franz Xaver, additional, von Lewinski, Dirk, additional, Moertl, Deddo, additional, Huber, Kurt, additional, Coussement, Patrick, additional, Hoffer, Etienne, additional, Beauloye, Christophe, additional, Janssens, Luc, additional, Vranckx, Pascal, additional, De Raedt, Herbert, additional, Vanassche, Thomas, additional, Vrolix, Matthias, additional, Rokyta, Richard, additional, Parenica, Jiri, additional, Pelouch, Radek, additional, Motovska, Zuzanna, additional, Alan, David, additional, Kettner, Jiri, additional, Polasek, Rostislav, additional, Cermak, Ondrej, additional, Sedlon, Pavel, additional, Hanis, Jiri, additional, Novak, Martin, additional, Belohlavek, Jan, additional, Horacek, Thomas, additional, Leggewie, Stefan, additional, Wenzel, Philip, additional, vom Dahl, Juergen, additional, Sievers, Burkhard, additional, Pulz, Jan, additional, Schellong, Sebastian, additional, Clemmensen, Peter, additional, Muller-Hennessen, Matthias, additional, Rassaf, Tienush, additional, Falukozi, Jozsef, additional, Ruzsa, Zoltan, additional, Tomcsanyi, Janos, additional, Csanadi, Zoltan, additional, Herczeg, Bela, additional, Koszegi, Zsolt, additional, Vorobcsuk, Andras, additional, Kiss, Robert, additional, Baranyai, Csaba, additional, Dezsi, Csaba, additional, Lupkovics, Geza, additional, Rossini, Roberta, additional, Scherillo, Marino, additional, Sergio Saba, Pier, additional, Calogero Campo, Gianluca, additional, Calo, Leonardo, additional, Nassiacos, Daniele, additional, Quadri, Giorgio, additional, Sciahbasi, Alessandro, additional, Silvio Marenzi, Gian Carlo, additional, Reimers, Bernhard, additional, Perna, Gian Piero, additional, Sacca, Salvatore, additional, Fattore, Luciano, additional, Brunelli, Claudio, additional, Picchi, Andrea, additional, Kuramochi, Takehiko, additional, Kondo, Kazuhisa, additional, Aoyama, Takahiko, additional, Kudoh, Takashi, additional, Yamamoto, Tadashi, additional, Takaya, Tomofumi, additional, Mukai, Yasushi, additional, Fukui, Kazuki, additional, Morioka, Nobuyuki, additional, Ando, Kenji, additional, Yamamuro, Atsushi, additional, Morita, Yasuhiro, additional, Koga, Yasuaki, additional, Watanabe, Tetsuya, additional, Sakamoto, Tomohiro, additional, Maebuchi, Daisuke, additional, Takahashi, Akihiko, additional, Yonetsu, Taishi, additional, Kakuta, Tsunekazu, additional, Nishina, Hidetaka, additional, Oemrawsingh, Rohit, additional, Dorman, Reinhart, additional, Oude Ophius, Ton, additional, Prins, Paco, additional, al Windy, N.Y.Y., additional, Zoet-Nugteren, S.K., additional, Hermanides, Rik, additional, van Eck, Martijn, additional, Scherptong, Roderick, additional, Cornel, J.H., additional, Damman, Peter, additional, Bech, Gerhard, additional, Torquay, R., additional, Kietselaer, Bas, additional, Grzelakowski, Pawel, additional, Krzysztof, Dyrbus, additional, Miekus, Pawel, additional, Przybylski, Andrzej, additional, Zarebinski, Maciej, additional, Balsam, Pawel, additional, Szachniewicz, Joanna, additional, Gierlotka, Marek, additional, Tycinska, Agnieszka, additional, Iniguez Romo, Andres, additional, Fernandez Ortiz, Antonio, additional, Carrasquer Cucarella, Anna, additional, Sanmartin Fernandez, Marcelo, additional, Sionis, Alessandro, additional, Bueno Zamora, Hector, additional, Ferreiro Gutierrez, Jose Luis, additional, Almenar, Luis, additional, Ferreira Gonzalez, Ignacio, additional, Pascual Figal, Domingo A., additional, Almendro Delia, Manuel, additional, Jimenez Fernandez, Miriam, additional, Skeppholm, Mika, additional, Zedigh, Crister, additional, Angeras, Oskar, additional, Lauermann, Jorg, additional, Erlinge, David, additional, Gustafsson, Robin, additional, Mooe, Thomas, additional, Utreras, Alejandro, additional, James, Stefan, additional, Grimfjard, Per, additional, Pedrazzini, Giovanni, additional, Mach, Francois, additional, Fournier, Stephane, additional, Haegeli, Laurent, additional, Beer, Jurg H., additional, Leibundgut, Gregor, additional, Kobza, Richard, additional, Kaiser, Christoph, additional, Kunadian, Vijay, additional, Al-Lamee, Rasha, additional, Gorog, Diana, additional, Khan, Sohail, additional, Trevelyan, Jasper, additional, Toor, Iqbal, additional, Smith, James, additional, Purushottam, Bhaskar, additional, Treasure, Charles, additional, Arena, Frank, additional, Vedere, Amarnath, additional, Henderson, David, additional, Gilani, Syed, additional, Jones, Alonzo, additional, Carrillo-Jimenez, Rodolfo, additional, Gillespie, Eve, additional, Marhefka, Gregary, additional, Wang, David, additional, Olson, Charles, additional, Bloom, Stephen, additional, Iftikhar, Faizan, additional, Brabham, David, additional, McGinty, John, additional, Thompson, Charles, additional, Talano, James, additional, Ginete, Wilson, additional, Williams, Marcus, additional, Masud, Ali, additional, Ariani, Mehrdad, additional, Bitar, Fahed, additional, Wang, Thomas, additional, and Samuelson, Bradley, additional

Published
2022
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8. A Multicenter, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Finding Trial of the Oral Factor XIa Inhibitor Asundexian to Prevent Adverse Cardiovascular Outcomes After Acute Myocardial Infarction

Author

Rao, Sunil, V, Kirsch, Bodo, Bhatt, Deepak L., Budaj, Andrzej, Coppolecchia, Rosa, Eikelboom, John, James, Stefan, Jones, W. Schuyler, Merkely, Bela, Keller, Lars, Hermanides, Renicus S., Campo, Gianluca, Ferreiro, Jose Luis, Shibasaki, Taro, Mundl, Hardi, Alexander, John H., Rao, Sunil, V, Kirsch, Bodo, Bhatt, Deepak L., Budaj, Andrzej, Coppolecchia, Rosa, Eikelboom, John, James, Stefan, Jones, W. Schuyler, Merkely, Bela, Keller, Lars, Hermanides, Renicus S., Campo, Gianluca, Ferreiro, Jose Luis, Shibasaki, Taro, Mundl, Hardi, and Alexander, John H.

Abstract

BACKGROUND: Oral activated factor XI (FXIa) inhibitors may modulate coagulation to prevent thromboembolic events without substantially increasing bleeding. We explored the pharmacodynamics, safety, and efficacy of the oral FXIa inhibitor asundexian for secondary prevention after acute myocardial infarction (MI). METHODS: We randomized 1601 patients with recent acute MI to oral asundexian 10, 20, or 50 mg or placebo once daily for 6 to 12 months in a double-blind, placebo-controlled, phase 2, dose-ranging trial. Patients were randomized within 5 days of their qualifying MI and received dual antiplatelet therapy with aspirin plus a P2Y12 inhibitor. The effect of asundexian on FXIa inhibition was assessed at 4 weeks. The prespecified main safety outcome was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding comparing all pooled asundexian doses with placebo. The prespecified efficacy outcome was a composite of cardiovascular death, MI, stroke, or stent thrombosis comparing pooled asundexian 20 and 50 mg doses with placebo. RESULTS: The median age was 68 years, 23% of participants were women, 51% had ST-segment-elevation MI, 80% were treated with aspirin plus ticagrelor or prasugrel, and 99% underwent percutaneous coronary intervention before randomization. Asundexian caused dose-related inhibition of FXIa activity, with 50 mg resulting in >90% inhibition. Over a median follow-up of 368 days, the main safety outcome occurred in 30 (7.6%), 32 (8.1%), 42 (10.5%), and 36 (9.0%) patients receiving asundexian 10 mg, 20 mg, or 50 mg, or placebo, respectively (pooled asundexian versus placebo: hazard ratio, 0.98 [90% CI, 0.71-1.35]). The efficacy outcome occurred in 27 (6.8%), 24 (6.0%), 22 (5.5%), and 22 (5.5%) patients assigned asundexian 10 mg, 20 mg, or 50 mg, or placebo, respectively (pooled asundexian 20 and 50 mg versus placebo: hazard ratio, 1.05 [90% CI, 0.69-1.61]). CONCLUSIONS: In patients with recent acute MI, 3 doses of asundexian, when added to asp

Published
2022
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13. Use of aspirin to reduce risk of initial vascular events in patients at moderate risk of cardiovascular disease (ARRIVE): a randomised, double-blind, placebo-controlled trial.

Author

Brett, Allan S., Gaziano, J Michael, Brotons, Carlos, Coppolecchia, Rosa, Cricelli, Claudio, Darius, Harald, Gorelick, Philip B, Howard, George, Pearson, Thomas A, Rothwell, Peter M, Ruilope, Luis Miguel, Tendera, Michal, Tognoni, Gianni, and ARRIVE Executive Committee

Subjects
STROKE prevention, ASPIRIN, CLINICAL trials, COMPARATIVE studies, GASTROINTESTINAL hemorrhage, LONGITUDINAL method, RESEARCH methodology, MEDICAL cooperation, MYOCARDIAL infarction, RESEARCH, STROKE, EVALUATION research, RANDOMIZED controlled trials, PROPORTIONAL hazards models, BLIND experiment, PLATELET aggregation inhibitors, PREVENTION
Abstract

Background: The use of aspirin in the primary prevention of cardiovascular events remains controversial. We aimed to assess the efficacy and safety of aspirin versus placebo in patients with a moderate estimated risk of a first cardiovascular event.Methods: ARRIVE is a randomised, double-blind, placebo-controlled, multicentre study done in seven countries. Eligible patients were aged 55 years (men) or 60 years (women) and older and had an average cardiovascular risk, deemed to be moderate on the basis of the number of specific risk factors. We excluded patients at high risk of gastrointestinal bleeding or other bleeding, or diabetes. Patients were randomly assigned (1:1) with a computer-generated randomisation code to receive enteric-coated aspirin tablets (100 mg) or placebo tablets, once daily. Patients, investigators, and others involved in treatment or data analysis were masked to treatment allocation. The primary efficacy endpoint was a composite outcome of time to first occurrence of cardiovascular death, myocardial infarction, unstable angina, stroke, or transient ischaemic attack. Safety endpoints were haemorrhagic events and incidence of other adverse events, and were analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00501059.Findings: Between July 5, 2007, and Nov 15, 2016, 12 546 patients were enrolled and randomly assigned to receive aspirin (n=6270) or placebo (n=6276) at 501 study sites. Median follow-up was 60 months. In the intention-to-treat analysis, the primary endpoint occurred in 269 (4·29%) patients in the aspirin group versus 281 (4·48%) patients in the placebo group (hazard ratio [HR] 0·96; 95% CI 0·81-1·13; p=0·6038). Gastrointestinal bleeding events (mostly mild) occurred in 61 (0·97%) patients in the aspirin group versus 29 (0·46%) in the placebo group (HR 2·11; 95% CI 1·36-3·28; p=0·0007). The overall incidence rate of serious adverse events was similar in both treatment groups (n=1266 [20·19%] in the aspirin group vs n=1311 [20·89%] in the placebo group. The overall incidence of adverse events was similar in both treatment groups (n=5142 [82·01%] vs n=5129 [81·72%] in the placebo group). The overall incidence of treatment-related adverse events was low (n=1050 [16·75%] vs n=850 [13·54%] in the placebo group; p<0·0001). There were 321 documented deaths in the intention-to-treat population (n=160 [2·55%] vs n=161 [2·57%] of 6276 patients in the placebo group).Interpretation: The event rate was much lower than expected, which is probably reflective of contemporary risk management strategies, making the study more representative of a low-risk population. The role of aspirin in primary prevention among patients at moderate risk could therefore not be addressed. Nonetheless, the findings with respect to aspirin's effects are consistent with those observed in the previously published low-risk primary prevention studies.Funding: Bayer. [ABSTRACT FROM AUTHOR]

Published
2018
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14. Asundexian versus Apixaban in Patients with Atrial Fibrillation.

Author

Piccini JP, Patel MR, Steffel J, Ferdinand K, Van Gelder IC, Russo AM, Ma CS, Goodman SG, Oldgren J, Hammett C, Lopes RD, Akao M, De Caterina R, Kirchhof P, Gorog DA, Hemels M, Rienstra M, Jones WS, Harrington J, Lip GYH, Ellis SJ, Rockhold FW, Neumann C, Alexander JH, Viethen T, Hung J, Coppolecchia R, Mundl H, and Caso V

Subjects
Aged, Aged, 80 and over, Female, Humans, Male, Administration, Oral, Double-Blind Method, Factor Xa Inhibitors administration & dosage, Factor Xa Inhibitors adverse effects, Hydrocarbons, Fluorinated, Intention to Treat Analysis, Pyrazoles administration & dosage, Pyrazoles adverse effects, Pyridones administration & dosage, Pyridones adverse effects, Benzamides administration & dosage, Benzamides adverse effects, Triazoles administration & dosage, Triazoles adverse effects, Anticoagulants administration & dosage, Anticoagulants adverse effects, Atrial Fibrillation drug therapy, Atrial Fibrillation complications, Embolism epidemiology, Embolism etiology, Embolism prevention & control, Hemorrhage chemically induced, Hemorrhage epidemiology, Stroke epidemiology, Stroke etiology, Stroke prevention & control
Abstract

Background: Stroke prevention with direct-acting oral anticoagulant agents in patients with atrial fibrillation confers a risk of bleeding and limits their use. Asundexian, an activated factor XI (XIa) inhibitor, is an oral anticoagulant that may prevent strokes with less bleeding., Methods: In a phase 3, international, double-blind trial, we randomly assigned high-risk patients with atrial fibrillation in a 1:1 ratio to receive asundexian at a dose of 50 mg once daily or standard-dose apixaban. The primary efficacy objective was to determine whether asundexian is at least noninferior to apixaban for the prevention of stroke or systemic embolism. The primary safety objective was to determine whether asundexian is superior to apixaban with respect to major bleeding events., Results: A total of 14,810 randomly assigned patients were included in the intention-to-treat population. The mean (±SD) age of the patients was 73.9±7.7 years, 35.2% were women, 18.6% had chronic kidney disease, 18.2% had a previous stroke or transient ischemic attack, 16.8% had received oral anticoagulants for no more than 6 weeks, and the mean CHA 2 DS 2 -VASc score (range, 0 to 9, with higher scores indicating a greater risk of stroke) was 4.3±1.3. The trial was stopped prematurely at the recommendation of the independent data monitoring committee. Stroke or systemic embolism occurred in 98 patients (1.3%) assigned to receive asundexian and in 26 (0.4%) assigned to receive apixaban (hazard ratio, 3.79; 95% confidence interval [CI], 2.46 to 5.83). Major bleeding occurred in 17 patients (0.2%) who received asundexian and in 53 (0.7%) who received apixaban (hazard ratio, 0.32; 95% CI, 0.18 to 0.55). The incidence of any adverse event appeared to be similar in the two groups., Conclusions: Among patients with atrial fibrillation at risk for stroke, treatment with asundexian at a dose of 50 mg once daily was associated with a higher incidence of stroke or systemic embolism than treatment with apixaban in the period before the trial was stopped prematurely. There were fewer major bleeding events with asundexian than with apixaban during this time. (Funded by Bayer; OCEANIC-AF ClinicalTrials.gov number, NCT05643573; EudraCT number, 2022-000758-28.)., (Copyright © 2024 Massachusetts Medical Society.)

Published
2025
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