Study Summary
This trial compares the safety and financial benefits of two different drugs to prevent blood clots in people with a heart condition.
Eligible Conditions
- Atrial Fibrillation
- Stroke
- Bleeding
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 13 Secondary · Reporting Duration: Up to 6 months following the cardiac operation
Day 30
Average score on the Perception of Anticoagulant Treatment Questionnaire (PACT-Q2)
Cerebrovascular accident (CVA)
Deep venous thrombosis (DVT) and/or Pulmonary Embolism (PE)
Hemorrhage
Hospital Readmission
Minor Bleeding
Number of Transfusions
Other systemic embolism
Performance on the EUROQOL (EQ-5D) Quality of Life Instrument
Rate of Mortality
Rate of ongoing atrial fibrillation
Rates of adverse clinical outcomes
Therapy related costs of anticoagulation
Month 6
Postoperative Length of Stay
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Rivaroxaban
24%Others
4%Constipation
4%Hypertension
3%Dizziness
3%Nausea
2%Anaemia
2%Musculoskeletal pain
1%Large intestine polyp
1%International normalised ratio increased
1%Cerebral infarction
1%Depression
1%Hypotension
1%Atrial fibrillation
1%Gastrooesophageal reflux disease
1%Stroke in evolution
1%Insomnia
Trial Design
2 Treatment Groups
Warfarin
1 of 2
Rivaroxaban
1 of 2
Active Control
Experimental Treatment
300 Total Participants · 2 Treatment Groups
Primary Treatment: Rivaroxaban · No Placebo Group · Phase 3
Rivaroxaban
Drug
Experimental Group · 1 Intervention: Rivaroxaban · Intervention Types: DrugWarfarin
Drug
ActiveComparator Group · 1 Intervention: Warfarin · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rivaroxaban
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months following the cardiac operation
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,703 Previous Clinical Trials
30,852,860 Total Patients Enrolled
13 Trials studying Atrial Fibrillation
65,106 Patients Enrolled for Atrial Fibrillation
Thoralf M Sundt, MDPrincipal InvestigatorMassachusetts General Hospital
Asishana A Osho, MD, MPHPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
242 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
242 Patients Enrolled for Atrial Fibrillation
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are at least 18 years old.
References
- Anderson, Eric, Katie Johnke, David Leedahl, Matthew Glogoza, Roxanne Newman, and Cornelius Dyke. 2015. “Novel Oral Anticoagulants Vs Warfarin for the Management of Postoperative Atrial Fibrillation: Clinical Outcomes and Cost Analysis”. The American Journal of Surgery. Elsevier BV. doi:10.1016/j.amjsurg.2015.07.005.
- Connolly, Stuart J., Michael D. Ezekowitz, Salim Yusuf, John Eikelboom, Jonas Oldgren, Amit Parekh, Janice Pogue, et al.. 2009. “Dabigatran Versus Warfarin in Patients with Atrial Fibrillation”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa0905561.
- Spyropoulos, Alex C., Walter Ageno, Gregory W. Albers, C. Gregory Elliott, Jonathan L. Halperin, William R. Hiatt, Gregory A. Maynard, et al.. 2018. “Rivaroxaban for Thromboprophylaxis After Hospitalization for Medical Illness”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1805090.
- Charlton, Blake, Gboyega Adeboyeje, John J. Barron, Deborah Grady, Jaekyu Shin, and Rita F. Redberg. 2018. “Length of Hospitalization and Mortality for Bleeding During Treatment with Warfarin, Dabigatran, or Rivaroxaban”. Edited by Yu Ru Kou. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0193912.
- Butt, Jawad H., Ying Xian, Eric D. Peterson, Peter Skov Olsen, Rasmus Rørth, Anna Gundlund, Jonas B. Olesen, et al.. 2018. “Long-term Thromboembolic Risk in Patients with Postoperative Atrial Fibrillation After Coronary Artery Bypass Graft Surgery and Patients with Nonvalvular Atrial Fibrillation”. JAMA Cardiology. American Medical Association (AMA). doi:10.1001/jamacardio.2018.0405.
- Megens, Matthew R., Leonid Churilov, and Vincent Thijs. 2017. “New‐onset Atrial Fibrillation After Coronary Artery Bypass Graft and Long‐term Risk of Stroke: A Meta‐analysis”. Journal of the American Heart Association. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/jaha.117.007558.
- Gillinov, A. Marc, Emilia Bagiella, Alan J. Moskowitz, Jesse M. Raiten, Mark A. Groh, Michael E. Bowdish, Gorav Ailawadi, et al.. 2016. “Rate Control Versus Rhythm Control for Atrial Fibrillation After Cardiac Surgery”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1602002.
- Granger, Christopher B., John H. Alexander, John J.V. McMurray, Renato D. Lopes, Elaine M. Hylek, Michael Hanna, Hussein R. Al-Khalidi, et al.. 2011. “Apixaban Versus Warfarin in Patients with Atrial Fibrillation”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1107039.
- Osho, Asishana A., Philicia Moonsamy, Breanna R. Ethridge, Gregory A. Leya, David A. D’Alessandro, Arminder S. Jassar, Mauricio A. Villavicencio, et al.. 2020. “Rationale and Design of the Randomized Controlled Trial of New Oral Anticoagulants Versus Warfarin for Post Cardiac Surgery Atrial Fibrillation”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/sla.0000000000004459.
- Farag, Mohamed, and Diana A Gorog. 2015. “Rivaroxaban in Atrial Fibrillation Cardioversion: Insights from the X-vert Trial”. Future Cardiology. Future Medicine Ltd. doi:10.2217/fca.15.4.
- Giugliano, Robert P., Christian T. Ruff, Eugene Braunwald, Sabina A. Murphy, Stephen D. Wiviott, Jonathan L. Halperin, Albert L. Waldo, et al.. 2013. “Edoxaban Versus Warfarin in Patients with Atrial Fibrillation”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1310907.
- Patel, Manesh R., Kenneth W. Mahaffey, Jyotsna Garg, Guohua Pan, Daniel E. Singer, Werner Hacke, Günter Breithardt, et al.. 2011. “Rivaroxaban Versus Warfarin in Nonvalvular Atrial Fibrillation”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1009638.
- Gillinov, A. Marc, Emilia Bagiella, Alan J. Moskowitz, Jesse M. Raiten, Mark A. Groh, Michael E. Bowdish, Gorav Ailawadi, et al.. 2016. “Rate Control Versus Rhythm Control for Atrial Fibrillation After Cardiac Surgery”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1602002.
- Spyropoulos, Alex C., Walter Ageno, Gregory W. Albers, C. Gregory Elliott, Jonathan L. Halperin, William R. Hiatt, Gregory A. Maynard, et al.. 2018. “Rivaroxaban for Thromboprophylaxis After Hospitalization for Medical Illness”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1805090.
- Osho, Asishana A., Philicia Moonsamy, Breanna R. Ethridge, Gregory A. Leya, David A. D’Alessandro, Arminder S. Jassar, Mauricio A. Villavicencio, et al.. 2020. “Rationale and Design of the Randomized Controlled Trial of New Oral Anticoagulants Versus Warfarin for Post Cardiac Surgery Atrial Fibrillation”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/sla.0000000000004459.
- Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.
- Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009 Sep 17;361(12):1139-51. doi: 10.1056/NEJMoa0905561. Epub 2009 Aug 30. Erratum In: N Engl J Med. 2010 Nov 4;363(19):1877.
- Butt JH, Xian Y, Peterson ED, Olsen PS, Rorth R, Gundlund A, Olesen JB, Gislason GH, Torp-Pedersen C, Kober L, Fosbol EL. Long-term Thromboembolic Risk in Patients With Postoperative Atrial Fibrillation After Coronary Artery Bypass Graft Surgery and Patients With Nonvalvular Atrial Fibrillation. JAMA Cardiol. 2018 May 1;3(5):417-424. doi: 10.1001/jamacardio.2018.0405. Erratum In: JAMA Cardiol. 2018 Jun 1;3(6):505.
- Hawks MK, Bryce C. Rivaroxaban vs. Warfarin for Anticoagulation in Patients with Atrial Fibrillation Undergoing Ablation and Cardioversion. Am Fam Physician. 2016 Oct 1;94(7):Online. No abstract available.
- Megens MR, Churilov L, Thijs V. New-Onset Atrial Fibrillation After Coronary Artery Bypass Graft and Long-Term Risk of Stroke: A Meta-Analysis. J Am Heart Assoc. 2017 Dec 22;6(12):e007558. doi: 10.1161/JAHA.117.007558.
- Asishana A Osho 2019. "Rivaroxaban vs. Warfarin for Post Cardiac Surgery Atrial Fibrillation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03702582.
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