A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients

Summary

The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related death post-hospital discharge in high-risk, medically ill patients.

Timeline

Start

2014-01-07

Primary completion

2018-03-06

Completion

2018-05-03

Outcome

Missed primary endpoint

registry analysis (superiority test); Rivaroxaban 10 mg or 7.5 mg vs Placebo; p = 0.136; Hazard Ratio (HR) 0.76 (95% CI 0.52 to 1.09) NCT02111564 ↗

registry analysis (superiority test); Rivaroxaban 10 mg or 7.5 mg vs Placebo; p = 0.124; Hazard Ratio (HR) 1.88 (95% CI 0.84 to 4.23) NCT02111564 ↗

release “MARINER demonstrated that XARELTO® did not reduce the composite endpoint of venous thromboembolism (VTE), or blood clots, and VTE-related death” jnj.com ↗

Publications

• Background Raskob GE, Spyropoulos AC, Zrubek J, Ageno W, Albers G, Elliott CG, Halperin J, Haskell L, Hiatt WR, Maynard GA, Peters G, Spiro T, Steg PG, Suh EY, Weitz JI. The MARINER trial of rivaroxaban after hospital discharge for medical patients at high risk of VTE. Design, rationale, and clinical implications. Thromb Haemost. 2016 Jun 2;115(6):1240-8. doi: 10.1160/TH15-09-0756. Epub 2016 Feb 4.
• Raskob GE, Ageno W, Albers G, Elliott CG, Halperin J, Maynard G, Steg PG, Weitz JI, Albanese J, Yuan Z, Levitan B, Lu W, Suh EY, Spiro T, Lipardi C, Barnathan ES, Spyropoulos AC. Benefit-Risk Assessment of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness. J Am Heart Assoc. 2022 Oct 18;11(20):e026229. doi: 10.1161/JAHA.122.026229. Epub 2022 Oct 7.
• Spyropoulos AC, Raskob GE, Cohen AT, Ageno W, Weitz JI, Spiro TE, Lu W, Lipardi C, Albers GW, Elliott CG, Halperin JL, Hiatt WR, Maynard G, Steg PG, Sugarmann C, Barnathan ES. Association of Bleeding Severity With Mortality in Extended Thromboprophylaxis of Medically Ill Patients in the MAGELLAN and MARINER Trials. Circulation. 2022 May 10;145(19):1471-1479. doi: 10.1161/CIRCULATIONAHA.121.057847. Epub 2022 Apr 7.
• Raskob GE, Spyropoulos AC, Spiro TE, Lu W, Yuan Z, Levitan B, Suh E, Barnathan ES. Benefit-Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER. J Am Heart Assoc. 2021 Nov 16;10(22):e021579. doi: 10.1161/JAHA.121.021579. Epub 2021 Nov 10.
• Jamil A, Jamil U, Singh K, Khan F, Chi G. Extended Thromboprophylaxis With Betrixaban or Rivaroxaban for Acutely Ill Hospitalized Medical Patients: Meta-Analysis of Prespecified Subgroups. Crit Pathw Cardiol. 2021 Mar 1;20(1):16-24. doi: 10.1097/HPC.0000000000000232.
• Spyropoulos AC, Ageno W, Albers GW, Elliott CG, Halperin JL, Hiatt WR, Maynard GA, Steg PG, Weitz JI, Lu W, Spiro TE, Barnathan ES, Raskob GE. Post-Discharge Prophylaxis With Rivaroxaban Reduces Fatal and Major Thromboembolic Events in Medically Ill Patients. J Am Coll Cardiol. 2020 Jun 30;75(25):3140-3147. doi: 10.1016/j.jacc.2020.04.071.
• Weitz JI, Raskob GE, Spyropoulos AC, Spiro TE, De Sanctis Y, Xu J, Lu W, Suh E, Argenti D, Yang H, Albanese J, Lipardi C, Barnathan ES. Thromboprophylaxis with Rivaroxaban in Acutely Ill Medical Patients with Renal Impairment: Insights from the MAGELLAN and MARINER Trials. Thromb Haemost. 2020 Mar;120(3):515-524. doi: 10.1055/s-0039-1701009. Epub 2020 Jan 23.
• Spyropoulos AC, Ageno W, Albers GW, Elliott CG, Halperin JL, Hiatt WR, Maynard GA, Steg PG, Weitz JI, Suh E, Spiro TE, Barnathan ES, Raskob GE; MARINER Investigators. Rivaroxaban for Thromboprophylaxis after Hospitalization for Medical Illness. N Engl J Med. 2018 Sep 20;379(12):1118-1127. doi: 10.1056/NEJMoa1805090. Epub 2018 Aug 26.

Drugs

Indications