drugset / Trial / NCT01776424
Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
Phase 3
Completed
27395 enrolled
Bayer
Janssen Research & Development, LLC · collabPopulation Health Research Institute · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The primary objectives of this study are: * To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD); * To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.
Timeline
- Start
- 2013-02-28
- Primary completion
- 2017-07-21
- Completion
- 2021-06-15
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry Rivaroxaban 2.5mg + Aspirin 100mg vs Rivaroxaban Placebo + Aspirin 100mg; p = 0.00004; Hazard Ratio (HR) 0.76 (95% CI 0.66 to 0.86) reads as mixed primary results NCT01776424 ↗
registry Rivaroxaban 5mg + Aspirin Placebo vs Rivaroxaban Placebo + Aspirin 100mg; p = 0.11490; Hazard Ratio (HR) 0.90 (95% CI 0.79 to 1.03) reads as mixed primary results NCT01776424 ↗
registry Rivaroxaban 2.5mg + Aspirin 100mg vs Rivaroxaban Placebo + Aspirin 100mg; p <0.00001; Hazard Ratio (HR) 1.70 (95% CI 1.40 to 2.05) reads as mixed primary results NCT01776424 ↗
release “In February this year, as part of a planned interim analysis, the COMPASS study was found to have met its primary endpoint early” reads as met primary endpoint bayer.com ↗
release “COMPASS met its primary efficacy endpoint, with the XARELTO®/aspirin regimen shown to be superior to aspirin alone, reducing major CV events by 24%.” reads as met primary endpoint jnj.com ↗
Publications
- Background Eikelboom JW, Bosch J, Connolly SJ, Tyrwitt J, Fox KAA, Muehlhofer E, Neumann C, Tasto C, Bangdiwala SI, Diaz R, Alings M, Dagenais GR, Leong DP, Lonn EM, Avezum A, Piegas LS, Widimsky P, Parkhomenko AN, Bhatt DL, Branch KRH, Probstfield JL, Lopez-Jaramillo P, Ryden L, Pogosova N, Keltai K, Keltai M, Ertl G, Stoerk S, Dans AL, Lanas F, Liang Y, Zhu J, Torp-Pedersen C, Maggioni AP, Commerford PJ, Guzik TJ, Vanassche T, Verhamme P, O'Donnell M, Tonkin AM, Varigos JD, Vinereanu D, Felix C, Kim JH, Ibrahim KS, Lewis BS, Metsarinne KP, Aboyans V, Steg PG, Hori M, Kakkar A, Anand SS, Lamy A, Sharma M, Yusuf S. Long-Term Treatment with the Combination of Rivaroxaban and Aspirin in Patients with Chronic Coronary or Peripheral Artery Disease: Outcomes During the Open Label Extension of the COMPASS trial. Eur Heart J Cardiovasc Pharmacother. 2022 Dec 2;8(8):786-795. doi: 10.1093/ehjcvp/pvac023.
- Results Anand SS, Caron F, Eikelboom JW, Bosch J, Dyal L, Aboyans V, Abola MT, Branch KRH, Keltai K, Bhatt DL, Verhamme P, Fox KAA, Cook-Bruns N, Lanius V, Connolly SJ, Yusuf S. Major Adverse Limb Events and Mortality in Patients With Peripheral Artery Disease: The COMPASS Trial. J Am Coll Cardiol. 2018 May 22;71(20):2306-2315. doi: 10.1016/j.jacc.2018.03.008. Epub 2018 Mar 11.
- Results Anand SS, Bosch J, Eikelboom JW, Connolly SJ, Diaz R, Widimsky P, Aboyans V, Alings M, Kakkar AK, Keltai K, Maggioni AP, Lewis BS, Stork S, Zhu J, Lopez-Jaramillo P, O'Donnell M, Commerford PJ, Vinereanu D, Pogosova N, Ryden L, Fox KAA, Bhatt DL, Misselwitz F, Varigos JD, Vanassche T, Avezum AA, Chen E, Branch K, Leong DP, Bangdiwala SI, Hart RG, Yusuf S; COMPASS Investigators. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2018 Jan 20;391(10117):219-229. doi: 10.1016/S0140-6736(17)32409-1. Epub 2017 Nov 10.
- Results Connolly SJ, Eikelboom JW, Bosch J, Dagenais G, Dyal L, Lanas F, Metsarinne K, O'Donnell M, Dans AL, Ha JW, Parkhomenko AN, Avezum AA, Lonn E, Lisheng L, Torp-Pedersen C, Widimsky P, Maggioni AP, Felix C, Keltai K, Hori M, Yusoff K, Guzik TJ, Bhatt DL, Branch KRH, Cook Bruns N, Berkowitz SD, Anand SS, Varigos JD, Fox KAA, Yusuf S; COMPASS investigators. Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2018 Jan 20;391(10117):205-218. doi: 10.1016/S0140-6736(17)32458-3. Epub 2017 Nov 10.
- Results Eikelboom JW, Connolly SJ, Bosch J, Dagenais GR, Hart RG, Shestakovska O, Diaz R, Alings M, Lonn EM, Anand SS, Widimsky P, Hori M, Avezum A, Piegas LS, Branch KRH, Probstfield J, Bhatt DL, Zhu J, Liang Y, Maggioni AP, Lopez-Jaramillo P, O'Donnell M, Kakkar AK, Fox KAA, Parkhomenko AN, Ertl G, Stork S, Keltai M, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Tonkin AM, Lewis BS, Felix C, Yusoff K, Steg PG, Metsarinne KP, Cook Bruns N, Misselwitz F, Chen E, Leong D, Yusuf S; COMPASS Investigators. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease. N Engl J Med. 2017 Oct 5;377(14):1319-1330. doi: 10.1056/NEJMoa1709118. Epub 2017 Aug 27.
- Results Bosch J, Eikelboom JW, Connolly SJ, Bruns NC, Lanius V, Yuan F, Misselwitz F, Chen E, Diaz R, Alings M, Lonn EM, Widimsky P, Hori M, Avezum A, Piegas LS, Bhatt DL, Branch KRH, Probstfield JL, Liang Y, Liu L, Zhu J, Maggioni AP, Lopez-Jaramillo P, O'Donnell M, Fox KAA, Kakkar A, Parkhomenko AN, Ertl G, Stork S, Keltai K, Keltai M, Ryden L, Dagenais GR, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Ha JW, Tonkin AM, Varigos JD, Lewis BS, Felix C, Yusoff K, Steg PG, Aboyans V, Metsarinne KP, Anand SS, Hart RG, Lamy A, Moayyedi P, Leong DP, Sharma M, Yusuf S. Rationale, Design and Baseline Characteristics of Participants in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) Trial. Can J Cardiol. 2017 Aug;33(8):1027-1035. doi: 10.1016/j.cjca.2017.06.001. Epub 2017 Jun 8.
- Results Braunwald E. An Important Step for Thrombocardiology. N Engl J Med. 2017 Oct 5;377(14):1387-1388. doi: 10.1056/NEJMe1710241. Epub 2017 Aug 27. No abstract available.
- Results Fauchier L, Bisson A, Angoulvant D. Rivaroxaban in Stable Cardiovascular Disease. N Engl J Med. 2018 Jan 26;378(4):395. doi: 10.1056/NEJMc1714934. No abstract available.
- Results Berger JS. Antithrombotic therapy in peripheral artery disease. Lancet. 2018 Jan 20;391(10117):183-184. doi: 10.1016/S0140-6736(17)32847-7. Epub 2017 Nov 10. No abstract available.
- Results Darmon A, Bhatt DL, Elbez Y, Aboyans V, Anand S, Bosch J, Branch KR, Connolly SJ, Dyal L, Eikelboom JW, Fox KAA, Keltai K, Probstfield J, Yusuf S, Abtan J, Sorbets E, Eagle KA, Ducrocq G, Steg PG. External applicability of the COMPASS trial: an analysis of the reduction of atherothrombosis for continued health (REACH) registry. Eur Heart J. 2018 Mar 1;39(9):750-757a. doi: 10.1093/eurheartj/ehx658.
- Results Verheugt FWA. Return of Oral Anticoagulation in Chronic Stable Coronary Disease. Circulation. 2018 Apr 17;137(16):1655-1657. doi: 10.1161/CIRCULATIONAHA.117.032916. No abstract available.
- Results Fox KAA, Eikelboom JW, Anand SS, Bhatt DL, Bosch J, Connolly SJ, Harrington RA, Steg PG, Yusuf S. Anti-thrombotic options for secondary prevention in patients with chronic atherosclerotic vascular disease: what does COMPASS add? Eur Heart J. 2019 May 7;40(18):1466-1471. doi: 10.1093/eurheartj/ehy347. No abstract available.
- Results Sharma M, Hart RG, Smith EE, Bosch J, Yuan F, Casanova A, Eikelboom JW, Connolly SJ, Wong G, Diaz R, Lopez-Jaramillo P, Ertl G, Stork S, Dagenais GR, Lonn EM, Ryden L, Tonkin AM, Varigos JD, Bhatt DL, Branch KR, Probstfield JL, Kim JH, Ha JW, O'Donnell M, Vinereanu D, Fox KA, Liang Y, Liu L, Zhu J, Pogosova N, Maggioni AP, Avezum A, Piegas LS, Keltai K, Keltai M, Cook Bruns N, Berkowitz S, Yusuf S. Rationale, design, and baseline participant characteristics in the MRI and cognitive substudy of the cardiovascular outcomes for people using anticoagulation strategies trial. Int J Stroke. 2019 Apr;14(3):270-281. doi: 10.1177/1747493018784478. Epub 2018 Jul 30.
- Results Kruger PC, Eikelboom JW, Yusuf S. Rivaroxaban with or without aspirin for prevention of cardiovascular disease. Coron Artery Dis. 2018 Aug;29(5):361-365. doi: 10.1097/MCA.0000000000000605. No abstract available.
- Results Ademi Z, Zomer E, Tonkin A, Liew D. Cost-effectiveness of rivaroxaban and aspirin compared to aspirin alone in patients with stable cardiovascular disease: An Australian perspective. Int J Cardiol. 2018 Nov 1;270:54-59. doi: 10.1016/j.ijcard.2018.06.091. Epub 2018 Jun 25.
- Results Bhagirath VC, Eikelboom JW, Anand SS. Low-dose rivaroxaban plus aspirin for the prevention of cardiovascular events: an evaluation of COMPASS. Future Cardiol. 2018 Nov;14(6):443-453. doi: 10.2217/fca-2018-0059. Epub 2018 Nov 12.
- Results Kruger PC, Anand SS, de Vries TAC, Eikelboom JW. Patients with Peripheral Artery Disease in the COMPASS Trial. Eur J Vasc Endovasc Surg. 2018 Dec;56(6):772-773. doi: 10.1016/j.ejvs.2018.08.010. Epub 2018 Sep 10. No abstract available.
- Results Boden WE, Bhatt DL. Will COMPASS Point to a New Direction in Thrombotic Risk Reduction in Patients With Stable Cardiovascular Disease? Circulation. 2018 Aug 28;138(9):858-860. doi: 10.1161/CIRCULATIONAHA.118.035405. No abstract available.
- Results Lamy A, Eikelboom J, Sheth T, Connolly S, Bosch J, Fox KAA, Zhu J, Lonn E, Dagenais G, Widimsky P, Branch KRH, Bhatt DL, Zheng Z, Straka Z, Dagenais F, Kong Y, Marsden T, Lee SF, Copland I, Yusuf S. Rivaroxaban, Aspirin, or Both to Prevent Early Coronary Bypass Graft Occlusion: The COMPASS-CABG Study. J Am Coll Cardiol. 2019 Jan 22;73(2):121-130. doi: 10.1016/j.jacc.2018.10.048.
- Results Sharma M, Hart RG, Connolly SJ, Bosch J, Shestakovska O, Ng KKH, Catanese L, Keltai K, Aboyans V, Alings M, Ha JW, Varigos J, Tonkin A, O'Donnell M, Bhatt DL, Fox K, Maggioni A, Berkowitz SD, Bruns NC, Yusuf S, Eikelboom JW. Stroke Outcomes in the COMPASS Trial. Circulation. 2019 Feb 26;139(9):1134-1145. doi: 10.1161/CIRCULATIONAHA.118.035864.
- Results Coppens M, Weitz JI, Eikelboom JWA. Synergy of Dual Pathway Inhibition in Chronic Cardiovascular Disease. Circ Res. 2019 Feb;124(3):416-425. doi: 10.1161/CIRCRESAHA.118.313141.
- Results Moayyedi P, Eikelboom JW, Bosch J, Connolly SJ, Dyal L, Shestakovska O, Leong D, Anand SS, Stork S, Branch KRH, Bhatt DL, Verhamme PB, O'Donnell M, Maggioni AP, Lonn EM, Piegas LS, Ertl G, Keltai M, Cook Bruns N, Muehlhofer E, Dagenais GR, Kim JH, Hori M, Steg PG, Hart RG, Diaz R, Alings M, Widimsky P, Avezum A, Probstfield J, Zhu J, Liang Y, Lopez-Jaramillo P, Kakkar A, Parkhomenko AN, Ryden L, Pogosova N, Dans A, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik T, Vinereanu D, Tonkin AM, Lewis BS, Felix C, Yusoff K, Metsarinne K, Fox KAA, Yusuf S; COMPASS Investigators. Pantoprazole to Prevent Gastroduodenal Events in Patients Receiving Rivaroxaban and/or Aspirin in a Randomized, Double-Blind, Placebo-Controlled Trial. Gastroenterology. 2019 Aug;157(2):403-412.e5. doi: 10.1053/j.gastro.2019.04.041. Epub 2019 May 2.
- Results Fox KAA, Eikelboom JW, Shestakovska O, Connolly SJ, Metsarinne KP, Yusuf S. Rivaroxaban Plus Aspirin in Patients With Vascular Disease and Renal Dysfunction: From the COMPASS Trial. J Am Coll Cardiol. 2019 May 14;73(18):2243-2250. doi: 10.1016/j.jacc.2019.02.048.
- Results Cairns JA, Eikelboom JW, Shestakovska O, Yusuf S, DeMets D. Monitoring Emerging Data From the COMPASS Trial of an Antithrombotic Agent. J Am Coll Cardiol. 2019 Jun 4;73(21):2769-2772. doi: 10.1016/j.jacc.2019.03.479. No abstract available.
- Results Moayyedi P, Eikelboom JW, Bosch J, Connolly SJ, Dyal L, Shestakovska O, Leong D, Anand SS, Stork S, Branch KRH, Bhatt DL, Verhamme PB, O'Donnell M, Maggioni AP, Lonn EM, Piegas LS, Ertl G, Keltai M, Bruns NC, Muehlhofer E, Dagenais GR, Kim JH, Hori M, Steg PG, Hart RG, Diaz R, Alings M, Widimsky P, Avezum A, Probstfield J, Zhu J, Liang Y, Lopez-Jaramillo P, Kakkar AK, Parkhomenko AN, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Vinereanu D, Tonkin AM, Lewis BS, Felix C, Yusoff K, Metsarinne KP, Fox KAA, Yusuf S; COMPASS Investigators. Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin. Gastroenterology. 2019 Sep;157(3):682-691.e2. doi: 10.1053/j.gastro.2019.05.056. Epub 2019 May 29.
- Results Kruger PC, Guzik TJ, Eikelboom JW. How can the results of the COMPASS trial benefit patients with coronary or peripheral artery disease in Poland? Kardiol Pol. 2019 Aug 23;77(7-8):661-669. doi: 10.33963/KP.14855. Epub 2019 May 30.
- Results Branch KR, Probstfield JL, Eikelboom JW, Bosch J, Maggioni AP, Cheng RK, Bhatt DL, Avezum A, Fox KAA, Connolly SJ, Shestakovska O, Yusuf S. Rivaroxaban With or Without Aspirin in Patients With Heart Failure and Chronic Coronary or Peripheral Artery Disease. Circulation. 2019 Aug 13;140(7):529-537. doi: 10.1161/CIRCULATIONAHA.119.039609. Epub 2019 Jun 5.
- Results Darmon A, Sorbets E, Ducrocq G, Elbez Y, Abtan J, Popovic B, Ohman EM, Rother J, Wilson PF, Montalescot G, Zeymer U, Bhatt DL, Steg PG; REACH Registry Investigators. Association of Multiple Enrichment Criteria With Ischemic and Bleeding Risks Among COMPASS-Eligible Patients. J Am Coll Cardiol. 2019 Jul 2;73(25):3281-3291. doi: 10.1016/j.jacc.2019.04.046.
- Results Anand SS, Eikelboom JW, Dyal L, Bosch J, Neumann C, Widimsky P, Avezum AA, Probstfield J, Cook Bruns N, Fox KAA, Bhatt DL, Connolly SJ, Yusuf S; COMPASS Trial Investigators. Rivaroxaban Plus Aspirin Versus Aspirin in Relation to Vascular Risk in the COMPASS Trial. J Am Coll Cardiol. 2019 Jul 2;73(25):3271-3280. doi: 10.1016/j.jacc.2019.02.079.
- Results Fox KAA, Metra M, Morais J, Atar D. The myth of 'stable' coronary artery disease. Nat Rev Cardiol. 2020 Jan;17(1):9-21. doi: 10.1038/s41569-019-0233-y. Epub 2019 Jul 29.
- Results de Vries TI, Eikelboom JW, Bosch J, Westerink J, Dorresteijn JAN, Alings M, Dyal L, Berkowitz SD, van der Graaf Y, Fox KAA, Visseren FLJ. Estimating individual lifetime benefit and bleeding risk of adding rivaroxaban to aspirin for patients with stable cardiovascular disease: results from the COMPASS trial. Eur Heart J. 2019 Dec 7;40(46):3771-3778a. doi: 10.1093/eurheartj/ehz404.
- Results Eikelboom JW, Connolly SJ, Bosch J, Shestakovska O, Aboyans V, Alings M, Anand SS, Avezum A, Berkowitz SD, Bhatt DL, Cook-Bruns N, Felix C, Fox KAA, Hart RG, Maggioni AP, Moayyedi P, O'Donnell M, Ryden L, Verhamme P, Widimsky P, Zhu J, Yusuf S. Bleeding and New Cancer Diagnosis in Patients With Atherosclerosis. Circulation. 2019 Oct 29;140(18):1451-1459. doi: 10.1161/CIRCULATIONAHA.119.041949. Epub 2019 Sep 12.
- Results Perera KS, Ng KKH, Nayar S, Catanese L, Dyal L, Sharma M, Connolly SJ, Yusuf S, Bosch J, Eikelboom JW, Hart RG. Association Between Low-Dose Rivaroxaban With or Without Aspirin and Ischemic Stroke Subtypes: A Secondary Analysis of the COMPASS Trial. JAMA Neurol. 2020 Jan 1;77(1):43-48. doi: 10.1001/jamaneurol.2019.2984.
- Results Eikelboom JW, Bosch JJ, Connolly SJ, Shestakovska O, Dagenais GR, Hart RG, Leong DP, O'Donnell M, Fox KAA, Bhatt DL, Cairns JA, Tasto C, Berkowitz SD, Cook Bruns N, Muehlhofer E, Diaz R, Maggioni AP, Yusuf S. Major Bleeding in Patients With Coronary or Peripheral Artery Disease Treated With Rivaroxaban Plus Aspirin. J Am Coll Cardiol. 2019 Sep 24;74(12):1519-1528. doi: 10.1016/j.jacc.2019.07.065.
- Results Wurtz M, Olesen KKW, Thim T, Kristensen SD, Eikelboom JW, Maeng M. External applicability of the COMPASS trial: the Western Denmark Heart Registry. Eur Heart J Cardiovasc Pharmacother. 2019 Oct 1;5(4):192-199. doi: 10.1093/ehjcvp/pvz013.
- Results Vanassche T, Verhamme P, Anand SS, Shestakovska O, Fox KA, Bhatt DL, Avezum A, Alings M, Aboyans V, Maggioni AP, Widimsky P, Berkowitz SD, Yusuf S, Connolly SJ, Eikelboom JW, Bosch J. Risk factors and clinical outcomes in chronic coronary and peripheral artery disease: An analysis of the randomized, double-blind COMPASS trial. Eur J Prev Cardiol. 2020 Feb;27(3):296-307. doi: 10.1177/2047487319882154. Epub 2019 Oct 15.
- Results Cowie MR, Lamy A, Levy P, Mealing S, Millier A, Mernagh P, Cristeau O, Bowrin K, Briere JB. Health economic evaluation of rivaroxaban in the treatment of patients with chronic coronary artery disease or peripheral artery disease. Cardiovasc Res. 2020 Sep 1;116(11):1918-1924. doi: 10.1093/cvr/cvz278.
- Results Welsh RC, Peterson ED, De Caterina R, Bode C, Gersh B, Eikelboom JW. Applying contemporary antithrombotic therapy in the secondary prevention of chronic atherosclerotic cardiovascular disease. Am Heart J. 2019 Dec;218:100-109. doi: 10.1016/j.ahj.2019.09.006. Epub 2019 Oct 23.
- Results Schiele F, Puymirat E, Ferrieres J, Simon T, Fox KAA, Eikelboom J, Danchin N; FAST-MI investigators. The FAST-MI 2005-2010-2015 registries in the light of the COMPASS trial: The COMPASS criteria applied to a post-MI population. Int J Cardiol. 2019 Mar 1;278:7-13. doi: 10.1016/j.ijcard.2018.11.138. Epub 2018 Dec 3.
- Results Bainey KR, Welsh RC, Connolly SJ, Marsden T, Bosch J, Fox KAA, Steg PG, Vinereanu D, Connolly DL, Berkowitz SD, Foody JM, Probstfield JL, Branch KR, Lewis BS, Diaz R, Muehlhofer E, Widimsky P, Yusuf S, Eikelboom JW, Bhatt DL; COMPASS Investigators. Rivaroxaban Plus Aspirin Versus Aspirin Alone in Patients With Prior Percutaneous Coronary Intervention (COMPASS-PCI). Circulation. 2020 Apr 7;141(14):1141-1151. doi: 10.1161/CIRCULATIONAHA.119.044598. Epub 2020 Mar 17.
- Results Liang Y, Zhu J, Liu L, Anand SS, Connolly SJ, Bosch J, Guzik TJ, O'Donnell M, Dagenais GR, Fox KA, Shestakovska O, Berkowitz SD, Muehlhofer E, Keller L, Yusuf S, Eikelboom JW; COMPASS Investigators. Efficacy and safety of rivaroxaban plus aspirin in women and men with chronic coronary or peripheral artery disease. Cardiovasc Res. 2021 Feb 22;117(3):942-949. doi: 10.1093/cvr/cvaa100.
- Results Bhatt DL, Eikelboom JW, Connolly SJ, Steg PG, Anand SS, Verma S, Branch KRH, Probstfield J, Bosch J, Shestakovska O, Szarek M, Maggioni AP, Widimsky P, Avezum A, Diaz R, Lewis BS, Berkowitz SD, Fox KAA, Ryden L, Yusuf S; COMPASS Steering Committee and Investigators. Role of Combination Antiplatelet and Anticoagulation Therapy in Diabetes Mellitus and Cardiovascular Disease: Insights From the COMPASS Trial. Circulation. 2020 Jun 9;141(23):1841-1854. doi: 10.1161/CIRCULATIONAHA.120.046448. Epub 2020 Mar 28.
- Results Steffel J, Eikelboom JW, Anand SS, Shestakovska O, Yusuf S, Fox KAA. The COMPASS Trial: Net Clinical Benefit of Low-Dose Rivaroxaban Plus Aspirin as Compared With Aspirin in Patients With Chronic Vascular Disease. Circulation. 2020 Jul 7;142(1):40-48. doi: 10.1161/CIRCULATIONAHA.120.046048. Epub 2020 May 21.
- Results Sharma M, Hart RG, Smith EE, Bosch J, Eikelboom JW, Connolly SJ, Dyal L, Reeh KW, Casanova A, Diaz R, Lopez-Jaramillo P, Ertl G, Stork S, Dagenais GR, Lonn EM, Ryden L, Tonkin AM, Varigos JD, Bhatt DL, Branch KRH, Probstfield JL, Kim JH, O'Donnell M, Vinereanu D, A A Fox K, Liang Y, Liu L, Zhu J, Pogosova N, Maggioni AP, Avezum A, Piegas LS, Keltai K, Keltai M, Berkowitz SD, Yusuf S. Rivaroxaban for Prevention of Covert Brain Infarcts and Cognitive Decline: The COMPASS MRI Substudy. Stroke. 2020 Oct;51(10):2901-2909. doi: 10.1161/STROKEAHA.120.029762. Epub 2020 Sep 21.
- Results Kaplovitch E, Eikelboom JW, Dyal L, Aboyans V, Abola MT, Verhamme P, Avezum A, Fox KAA, Berkowitz SD, Bangdiwala SI, Yusuf S, Anand SS. Rivaroxaban and Aspirin in Patients With Symptomatic Lower Extremity Peripheral Artery Disease: A Subanalysis of the COMPASS Randomized Clinical Trial. JAMA Cardiol. 2021 Jan 1;6(1):21-29. doi: 10.1001/jamacardio.2020.4390.
- Results Guzik TJ, Ramasundarahettige C, Pogosova N, Lopez-Jaramillo P, Dyal L, Berkowitz SD, Muehlhofer E, Bhatt DL, Fox KAA, Yusuf S, Eikelboom JW. Rivaroxaban Plus Aspirin in Obese and Overweight Patients With Vascular Disease in the COMPASS Trial. J Am Coll Cardiol. 2021 Feb 9;77(5):511-525. doi: 10.1016/j.jacc.2020.11.061.
- Results Sen J, Tonkin A, Varigos J, Fonguh S, Berkowitz SD, Yusuf S, Verhamme P, Vanassche T, Anand SS, Fox KAA, Eikelboom JW, Amerena J; COMPASS Trial Investigators. Risk stratification of cardiovascular complications using CHA2DS2-VASc and CHADS2 scores in chronic atherosclerotic cardiovascular disease. Int J Cardiol. 2021 Aug 15;337:9-15. doi: 10.1016/j.ijcard.2021.04.067. Epub 2021 May 3.
- Results Dagenais GR, Dyal L, Bosch JJ, Leong DP, Aboyans V, Berkowitz SD, Bhatt DL, Connolly SJ, Fox KAA, Muehlhofer E, Probstfield JL, Widimsky P, Winkelmann BR, Yusuf S, Eikelboom JW. Cardiovascular consequences of discontinuing low-dose rivaroxaban in people with chronic coronary or peripheral artery disease. Heart. 2021 Jul;107(14):1130-1137. doi: 10.1136/heartjnl-2020-318758. Epub 2021 May 21.
- Results Lamy A, Browne A, Sheth T, Zheng Z, Dagenais F, Noiseux N, Chen X, Bakaeen FG, Brtko M, Stevens LM, Alboom M, Lee SF, Copland I, Salim Y, Eikelboom J; COMPASS Investigators. Skeletonized vs Pedicled Internal Mammary Artery Graft Harvesting in Coronary Artery Bypass Surgery: A Post Hoc Analysis From the COMPASS Trial. JAMA Cardiol. 2021 Sep 1;6(9):1042-1049. doi: 10.1001/jamacardio.2021.1686.
- Results Vanassche T, Verhamme P, Anand SS, Shestakovska O, Leong DP, Fox KAA, Bhatt DL, Avezum A, Alings M, Aboyans V, Maggioni AP, Widimsky P, Muehlhofer E, Berkowitz SD, Yusuf S, Connolly SJ, Eikelboom JW, Bosch J. Low-dose rivaroxaban plus aspirin in patients with polypharmacy and multimorbidity: an analysis from the COMPASS trial. Eur Heart J Cardiovasc Pharmacother. 2022 Aug 11;8(5):462-473. doi: 10.1093/ehjcvp/pvab050.
- Results Eikelboom JW, Bhatt DL, Fox KAA, Bosch J, Connolly SJ, Anand SS, Avezum A, Berkowitz SD, Branch KRH, Dagenais GR, Felix C, Guzik TJ, Hart RG, Maggioni AP, Muehlhofer E, Sharma M, Shestakovska O, Yusuf S. Mortality Benefit of Rivaroxaban Plus Aspirin in Patients With Chronic Coronary or Peripheral Artery Disease. J Am Coll Cardiol. 2021 Jul 6;78(1):14-23. doi: 10.1016/j.jacc.2021.04.083.
- Results Anand SS, Hiatt W, Dyal L, Bauersachs R, Berkowitz SD, Branch KRH, Debus S, Fox KAA, Liang Y, Muehlhofer E, Nehler M, Haskell LP, Patel M, Szarek M, Yusuf S, Eikelboom J, Bonaca MP. Low-dose rivaroxaban and aspirin among patients with peripheral artery disease: a meta-analysis of the COMPASS and VOYAGER trials. Eur J Prev Cardiol. 2022 May 5;29(5):e181-e189. doi: 10.1093/eurjpc/zwab128.
- Results Kaplovitch E, Anand SS. The evolving treatment of peripheral arterial disease: preventing ischaemic events in the post-COMPASS era. Cardiovasc Res. 2019 Oct 1;115(12):e121-e124. doi: 10.1093/cvr/cvz170. No abstract available.
- Lee SF, Ramasundarahettige C, Gerstein HC, McIntyre WF, Eikelboom J, O'Donnell MJ, Zhou Y, Bangdiwala SI, Thabane L. Comparison of total event analysis and first event analysis in relation to heterogeneity in cardiovascular trials. BMC Med Res Methodol. 2025 Jun 9;25(1):159. doi: 10.1186/s12874-025-02593-3.
- Xie F, Yan J, Eikelboom J, Anand S, Muehlhofer E, Pullenayegum E, Wang Y, Avezum A, Bhatt DL, Yusuf S, Bosch J. Health-related quality of life with rivaroxaban plus aspirin vs. aspirin alone in chronic stable cardiovascular disease: Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial. Eur Heart J Open. 2024 Sep 27;4(5):oeae083. doi: 10.1093/ehjopen/oeae083. eCollection 2024 Sep.
- Eikelboom JW, Yi Q, McIntyre WF, Bosch J, Whitlock R, Connolly SJ, Scheier TC, Muehlhofer E, Pap AF, Pocock SJ, Bangdiwala SI. Results of the COMPASS Trial Analyzed Using Win Ratio Compared With Conventional Analytic Approaches. Can J Cardiol. 2024 Nov;40(11):2171-2179. doi: 10.1016/j.cjca.2024.07.002. Epub 2024 Jul 14.
- Leong DP, Bosch J, Bhatt DL, Avezum A, Yuan F, Yusuf S, Eikelboom JW. Impact of Frailty on the Benefits of Dual Pathway Inhibition for the Secondary Prevention of Cardiovascular Events in the COMPASS Randomised Trial. Can J Cardiol. 2025 Jan;41(1):102-111. doi: 10.1016/j.cjca.2024.06.017. Epub 2024 Jun 22.
- Pyne L, Smyth A, Molnar AO, Moayyedi P, Muehlhofer E, Yusuf S, Eikelboom J, Bosch J, Walsh M. The Effects of Pantoprazole on Kidney Outcomes: Post Hoc Observational Analysis from the COMPASS Trial. J Am Soc Nephrol. 2024 Jul 1;35(7):901-909. doi: 10.1681/ASN.0000000000000356. Epub 2024 Apr 11.
- Lamy A, Eikelboom J, Tong W, Yuan F, Bangdiwala SI, Bosch J, Connolly S, Lonn E, Dagenais GR, Branch KRH, Wang WJ, Bhatt DL, Probstfield J, Ertl G, Stork S, Steg PG, Aboyans V, Durand-Zaleski I, Ryden L, Yusuf S; COMPASS Investigators. The Cost-Effectiveness of Rivaroxaban Plus Aspirin Compared with Aspirin Alone in the COMPASS Trial: A US Perspective. Am J Cardiovasc Drugs. 2024 Jan;24(1):117-127. doi: 10.1007/s40256-023-00620-6. Epub 2023 Dec 28.
- Clezar CN, Flumignan CD, Cassola N, Nakano LC, Trevisani VF, Flumignan RL. Pharmacological interventions for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2023 Aug 4;8(8):CD013573. doi: 10.1002/14651858.CD013573.pub2.
- Branch KRH, Probstfield JL, Bosch J, Bhatt DL, Maggioni AP, Muehlhofer E, Avezum A, Widimsky P, Connolly SJ, Yi Q, Shestakovska O, Yusuf S, Eikelboom JW. Total events and net clinical benefit of rivaroxaban and aspirin in patients with chronic coronary or peripheral artery disease: The COMPASS trial. Am Heart J. 2023 Apr;258:60-68. doi: 10.1016/j.ahj.2023.01.008. Epub 2023 Jan 14.
- Smolderen KG, Mena-Hurtado C, Eikelboom JW, Bosch J, Xie F, Ramasundarahettige C, Bhatt DL, Anand SS. Health status and cognitive function for risk stratification in chronic coronary and peripheral artery disease. Eur J Prev Cardiol. 2023 May 9;30(7):535-545. doi: 10.1093/eurjpc/zwac282.
- Gaba P, Bhatt DL, Dagenais GR, Bosch J, Maggioni AP, Widimsky P, Leong D, Fox KAA, Yusuf S, Eikelboom JW; COMPASS Steering Committee and Investigators. Comparison of Investigator-Reported vs Centrally Adjudicated Major Adverse Cardiac Events: A Secondary Analysis of the COMPASS Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2243201. doi: 10.1001/jamanetworkopen.2022.43201.
- Lamy A, Eikelboom J, Tong W, Yuan F, Bangdiwala SI, Bosch J, Connolly S, Lonn E, Dagenais GR, Branch KRH, Wang WJ, Bhatt DL, Probstfield J, Ertl G, Stork S, Steg PG, Aboyans V, Durand-Zaleski I, Ryden L, Yusuf S. The cost-effectiveness of rivaroxaban with or without aspirin in the COMPASS trial. Eur Heart J Qual Care Clin Outcomes. 2023 Aug 7;9(5):502-510. doi: 10.1093/ehjqcco/qcac054.
- Alboom M, Browne A, Sheth T, Zheng Z, Dagenais F, Noiseux N, Brtko M, Stevens LM, Lee SF, Copland I, Power P, Eikelboom J, Lamy A. Conduit selection and early graft failure in coronary artery bypass surgery: A post hoc analysis of the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) coronary artery bypass grafting study. J Thorac Cardiovasc Surg. 2023 Mar;165(3):1080-1089.e1. doi: 10.1016/j.jtcvs.2022.05.028. Epub 2022 Jun 2.
- Catanese L, Eikelboom JW, Bosch J, Shestakovska O, Ng K, Nayar S, Perera KS, Shoamanesh A, Sharma M, Hart RG. Oral factor Xa inhibitors and risk of subdural hematoma: COMPASS trial results and meta-analysis. Neurology. 2020 Aug 4;95(5):e480-e487. doi: 10.1212/WNL.0000000000009826. Epub 2020 Jul 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | 100 mg | Oral |
| Subject | Pantoprazole | Other / unclassified | 40 mg | Oral |
| Subject | Rivaroxaban | Other / unclassified | 2.5 mg | Oral |
| Subject | Rivaroxaban | Other / unclassified | 5 mg | Oral |
Indications
No indication recorded.