Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease (COMPASS)

Tracking Information
First Submitted Date ICMJE	January 24, 2013
First Posted Date ICMJE	January 28, 2013
Last Update Posted Date	March 27, 2018
Actual Study Start Date ICMJE	February 28, 2013
Actual Primary Completion Date	July 21, 2017 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 3, 2017)	Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death [ Time Frame: Approximately 6 years ]; Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis) [ Time Frame: Approximately 6 years ]
Original Primary Outcome Measures ICMJE; (submitted: January 25, 2013)	Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death [ Time Frame: Approximately 5 years ]; Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis) [ Time Frame: Approximately 5 years ]
Change History	Complete list of historical versions of study NCT01776424 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 3, 2017)	Time from randomization to first occurrence of either coronary heart disease death, myocardial infarction, ischemic stroke, acute limb ischemia [ Time Frame: Approximately 6 years ]; Time from randomization to first occurrence of either cardiovascular death, myocardial infarction, ischemic stroke, acute limb ischemia [ Time Frame: Approximately 6 years ]; Time from randomization to first occurrence of all-cause mortality [ Time Frame: Approximately 6 years ]
Original Secondary Outcome Measures ICMJE; (submitted: January 25, 2013)	Time from randomization to first occurrence of either myocardial infarction, stroke, cardiovascular death, venous thromboembolism or cardiovascular hospitalization [ Time Frame: Approximately 5 years ]; Time from randomization to first occurrence of all-cause mortality [ Time Frame: Approximately 5 years ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
Official Title ICMJE	A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease (COMPASS - Cardiovascular OutcoMes for People Using Anticoagulation StrategieS).
Brief Summary	The primary purpose of this study is to evaluate whether treatment with rivaroxaban and aspirin or rivaroxaban alone is better than aspirin alone in prevention of heart attacks, stroke or cardiovascular death in patients with coronary or peripheral artery disease.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition ICMJE	Prevention &Amp; Control
Intervention ICMJE	Drug: Rivaroxaban (Xarelto, BAY59-7939) Rivaroxaban 2.5 mg twice daily, tablet; Drug: Rivaroxaban (Xarelto, BAY59-7939) Rivaroxaban 5.0 mg twice daily, tablet; Drug: Aspirin Aspirin 100 mg once daily, tablet; Drug: Aspirin placebo Placebo(1), matching Aspirin tablets; Drug: Rivaroxaban placebo Placebo(2), matching Rivaroxaban tablets; Drug: Pantoprazole Subjects who are not on a PPI (proton pump inhibitor) will also be randomized to pantoprazole or pantoprazole placebo
Study Arms	Experimental: Rivaroxaban [2.5mg] + Aspirin Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily. (Long-term open-label extension was added to make rivaroxaban 2.5 mg twice daily + aspirin 100 mg once daily available to COMPASS trial subjects until the rivaroxaban treatment is commercially available for this indication or for approximately 3 years from regulatory approval of the long term open label extension in a country, whichever comes first.) Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Aspirin Drug: Pantoprazole; Experimental: Rivaroxaban [5mg] + Placebo(1) Rivaroxaban 5 mg twice daily and Aspirin Placebo once daily Interventions: Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Aspirin placebo Drug: Pantoprazole; Active Comparator: Aspirin + Placebo(2) Rivaroxaban Placebo twice daily and Aspirin 100 mg once daily Interventions: Drug: Aspirin Drug: Rivaroxaban placebo Drug: Pantoprazole
Publications *	Anand SS, Bosch J, Eikelboom JW, Connolly SJ, Diaz R, Widimsky P, Aboyans V, Alings M, Kakkar AK, Keltai K, Maggioni AP, Lewis BS, Störk 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. 2017 Nov 10. pii: S0140-6736(17)32409-1. doi: 10.1016/S0140-6736(17)32409-1. [Epub ahead of print]; 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. 2017 Nov 10. pii: S0140-6736(17)32458-3. doi: 10.1016/S0140-6736(17)32458-3. [Epub ahead of print] Erratum in: Lancet. 2017 Dec 21;:.; 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, Störk 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Active, not recruiting
Actual Enrollment ICMJE; (submitted: April 3, 2017)	27395
Original Estimated Enrollment ICMJE; (submitted: January 25, 2013)	19500
Estimated Study Completion Date	June 30, 2021
Actual Primary Completion Date	July 21, 2017 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: -- Coronary or peripheral artery disease Patients with coronary artery disease must also meet at least one of the following: Age ≥65, or; Age <65 and documented atherosclerosis or revascularization involving at least 2 vascular beds, or at least 2 additional risk factors Exclusion Criteria: Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy or oral anticoagulant therapy; Stroke within 1 month or any history of hemorrhagic or lacunar stroke; Severe heart failure with known ejection fraction <30% or New York Heart Association (NYHA) class III or IV symptoms; Estimated glomerular filtration rate (eGFR)<15 mL/min
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Ecuador, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Sweden, Switzerland, Ukraine, United Kingdom, United States
Removed Location Countries	Czech Republic
Administrative Information
NCT Number ICMJE	NCT01776424
Other Study ID Numbers ICMJE	15786; 2012-004180-43 ( EudraCT Number )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement	Not Provided
Responsible Party	Bayer
Study Sponsor ICMJE	Bayer
Collaborators ICMJE	Hamilton Health Sciences Corporation, Population Health Research Institute; Janssen Research & Development, LLC
Investigators ICMJE	Study Director: Bayer Study Director Bayer
PRS Account	Bayer
Verification Date	March 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP