Phase III Acute Coronary Syndrome

Summary

The purpose of this study is to determine if apixaban is superior to placebo for preventing cardiovascular death, non-fatal myocardial infarction, or ischemic stroke in subjects with a recent acute coronary syndrome

Timeline

Start

2009-03

Primary completion

2011-03

Completion

2011-03

Publications

• Sharma A, Hagstrom E, Wojdyla DM, Neely ML, Harrington RA, Wallentin L, Alexander JH, Goodman SG, Lopes RD; Apixaban for Prevention of Acute Ischemic Safety Events APPRAISE-2 Steering Committee and Investigators. Clinical consequences of bleeding among individuals with a recent acute coronary syndrome: Insights from the APPRAISE-2 trial. Am Heart J. 2019 Sep;215:106-113. doi: 10.1016/j.ahj.2019.05.004. Epub 2019 May 11.
• Inohara T, Pieper K, Wojdyla DM, Patel MR, Jones WS, Tricoci P, Mahaffey KW, James SK, Alexander JH, Lopes RD, Wallentin L, Ohman EM, Roe MT, Vemulapalli S. Incidence, timing, and type of first and recurrent ischemic events in patients with and without peripheral artery disease after an acute coronary syndrome. Am Heart J. 2018 Jul;201:25-32. doi: 10.1016/j.ahj.2018.03.013. Epub 2018 Mar 28.
• Sherwood MW, Lopes RD, Sun JL, Liaw D, Harrington RA, Wallentin L, Laskowitz DT, James SK, Goodman SG, Darius H, Lewis BS, Gibson CM, Pieper KS, Alexander JH. Apixaban following acute coronary syndromes in patients with prior stroke: Insights from the APPRAISE-2 trial. Am Heart J. 2018 Mar;197:1-8. doi: 10.1016/j.ahj.2017.09.020. Epub 2017 Oct 24.
• Guimaraes PO, Lopes RD, Stevens SR, Zimerman A, Wruck L, James SK, Haque G, Giraldez RRCV, Alexander JH, Alexander KP. Reporting Clinical End Points and Safety Events in an Acute Coronary Syndrome Trial: Results With Integrated Collection. J Am Heart Assoc. 2017 Apr 24;6(4):e005490. doi: 10.1161/JAHA.117.005490.
• Hess CN, James S, Lopes RD, Wojdyla DM, Neely ML, Liaw D, Hagstrom E, Bhatt DL, Husted S, Goodman SG, Lewis BS, Verheugt FWA, De Caterina R, Ogawa H, Wallentin L, Alexander JH. Apixaban Plus Mono Versus Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights From the APPRAISE-2 Trial. J Am Coll Cardiol. 2015 Aug 18;66(7):777-787. doi: 10.1016/j.jacc.2015.06.027.
• Khan R, Lopes RD, Neely ML, Stevens SR, Harrington RA, Diaz R, Cools F, Jansky P, Montalescot G, Atar D, Lopez-Sendon J, Flather M, Liaw D, Wallentin L, Alexander JH, Goodman SG; Apixaban for Prevention of Acute Ischemic Safety Events (APPRAISE)-2 Steering Committee and Investigators. Characterising and predicting bleeding in high-risk patients with an acute coronary syndrome. Heart. 2015 Sep;101(18):1475-84. doi: 10.1136/heartjnl-2014-307346. Epub 2015 Jun 24.
• Mahaffey KW, Hager R, Wojdyla D, White HD, Armstrong PW, Alexander JH, Tricoci P, Lopes RD, Ohman EM, Roe MT, Harrington RA, Wallentin L. Meta-analysis of intracranial hemorrhage in acute coronary syndromes: incidence, predictors, and clinical outcomes. J Am Heart Assoc. 2015 Jun 18;4(6):e001512. doi: 10.1161/JAHA.114.001512.
• Alexander JH, Lopes RD, James S, Kilaru R, He Y, Mohan P, Bhatt DL, Goodman S, Verheugt FW, Flather M, Huber K, Liaw D, Husted SE, Lopez-Sendon J, De Caterina R, Jansky P, Darius H, Vinereanu D, Cornel JH, Cools F, Atar D, Leiva-Pons JL, Keltai M, Ogawa H, Pais P, Parkhomenko A, Ruzyllo W, Diaz R, White H, Ruda M, Geraldes M, Lawrence J, Harrington RA, Wallentin L; APPRAISE-2 Investigators. Apixaban with antiplatelet therapy after acute coronary syndrome. N Engl J Med. 2011 Aug 25;365(8):699-708. doi: 10.1056/NEJMoa1105819. Epub 2011 Jul 24.

Drugs

Indications