Back to resultsA Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure (COMMANDER HF)
Primary Purpose
Heart Failure, Coronary Artery Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rivaroxaban
Placebo
Standard of care for heart failure and coronary artery disease
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Coronary Artery Disease, Stroke, Myocardial Infarction, Anticoagulation
Eligibility Criteria
Inclusion Criteria:
- Must have symptomatic heart failure for at least 3 months prior to Screening
- Participants must have an episode of decompensated heart failure (index event) requiring (a) an overnight stay [that is, staying past midnight] in a hospital, emergency department, or medical facility with the capability of treating with intravenous medications and observing heart failure patients before randomization or (b) an unscheduled outpatient visit to a heart failure management center, where parenteral therapy is required for heart failure stabilization. An episode of decompensated heart failure is defined as symptoms of worsening dyspnea or fatigue, objective signs of congestion such as peripheral edema or ascites, and/or adjustment of pre-hospitalization/outpatient visit heart failure medications. Participants are eligible for randomization at discharge from the facility treating the index event and up to 30 days after discharge if they are in stable condition
- Must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40 percent (%) within 1 year before randomization
- Must have evidence of significant coronary artery disease
- Must be medically stable in terms of their heart failure clinical status at the time of randomization
- Must have a brain natriuretic peptide (BNP) level greater than or equal to (>=) 200 picogram per milliliter (pg/mL) or N-terminal-proBNP (NT-proBNP) level >=800 pg/mL (preferred assay) during the Screening period and before randomization
Exclusion Criteria:
- Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, active internal bleeding, clinically significant bleeding, bleeding at a noncompressible site, or bleeding diathesis within 28 days of randomization
- Severe concomitant disease such as (a) atrial fibrillation (AFib) or another condition that requires chronic anticoagulation (participants with isolated transient AFib may be allowed at the discretion of the treating physician investigator) and (b) Documented acute myocardial infarction (MI) during index event
- Prior stroke within 90 days of randomization
- Has been hospitalized for longer than 21 days during the index event
- Planned intermittent outpatient treatment with positive inotropic drugs administered intravenously
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rivaroxaban 2.5 mg
Placebo
Arm Description
Each participant will receive 2.5 mg of rivaroxaban twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
Each participant will receive matching placebo twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
Outcomes
Primary Outcome Measures
Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke
Event Rate of all-cause mortality (ACM), MI, or stroke were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 patient [pt]-year [yr]) = 100*n/(total risk exposure), where n is the number of events.
Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability
Event rate of either fatal bleeding or bleeding into critical space with potential for permanent disability were assessed. Fatal bleeding event was death within 7 days after a bleeding event which required hospitalization or met International Society on Thrombosis and Haemostasis(ISTH) major bleeding definition criteria. Fatal bleeding events included those met criteria in 3 categories: 1: Any ISTH major bleeding event consider primary cause of death by investigator; 2: Any ISTH major bleeding event not considered to be primary cause of death by investigator but resulted in death within 7 days;3: Any bleeding event resulted in hospital stay and death within 7 days. Bleeding into critical space with potential for permanent disability included 7 critical spaces: intracranial, intraspinal, intraocular. Event rate estimated based on time to first occurrence of event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
Secondary Outcome Measures
Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF)
Event rate of cardio vascular (CV) death or re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
Event Rate of Cardio Vascular Death
Event rate of cardio vascular death were assessed. CV death included deaths due to spontaneous bleeding, MI, stroke, worsening HF and arrhythmias, death due to CV procedures and sudden death. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
Event Rate of Re-Hospitalization for Worsening of Heart Failure
Event rate of re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV)
Event rate due to cardio vascular events were assessed. Hospitalization for a CV Event required that participants be hospitalized (in-patient or emergency department) for greater than 24 hours and must have met the following criterion:Discharge summary with primary reason for admission listed as CV in nature (example, bleeding, arrhythmia, ACS, MI) other than HF which was captured in the HF re-hospitalization. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
Event Rate of All-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure
Event rate of all-Cause Mortality (ACM) or re-Hospitalization for worsening heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
Event Rate of Bleeding Events That Requiring Hospitalization
Event rate of bleeding events and required Hospitalization were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
Event Rate of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding Event
Event rate of ISTH major bleeding event were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
Full Information
NCT ID
NCT01877915
First Posted
June 12, 2013
Last Updated
April 18, 2019
Sponsor
Janssen Research & Development, LLC
Collaborators
Bayer
1. Study Identification
Unique Protocol Identification Number
NCT01877915
Brief Title
A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure
Acronym
COMMANDER HF
Official Title
A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Rivaroxaban With Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects With Heart Failure and Significant Coronary Artery Disease Following an Episode of Decompensated Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 10, 2013 (Actual)
Primary Completion Date
April 19, 2018 (Actual)
Study Completion Date
April 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
Collaborators
Bayer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared with placebo (inactive medication), in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure.
Detailed Description
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), parallel group (each participant group receives different treatments simultaneously), event driven (the study duration is determined by the time taken for a specific number of events to occur), multicenter study to assess the effectiveness and safety of rivaroxaban compared with placebo, in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure. Participants will be randomly assigned in a 1:1 ratio to receive either rivaroxaban or placebo (each in addition to standard of care for heart failure and coronary artery disease as prescribed by their managing physician). The study will consist of a screening phase, a double-blind treatment phase, and a follow-up after the sponsor-announced global treatment end date (GTED, defined as the date when 1200 primary efficacy outcome events are predicted to have occurred). The double-blind treatment phase is estimated to last for 6 to 54 months. Participants will discontinue study drug after taking both their morning and evening doses on the GTED and will return to the study center for the end-of-study visit (between 15 and 45 days but no sooner than 15 days after the GTED). Patient safety will be monitored throughout the study. The average study duration for participants is expected to be approximately 29 months. The study drug, rivaroxaban, is approved in the United States and in multiple countries around the world for the prevention and treatment of a number of thrombosis-mediated conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Coronary Artery Disease
Keywords
Heart Failure, Coronary Artery Disease, Stroke, Myocardial Infarction, Anticoagulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5081 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rivaroxaban 2.5 mg
Arm Type
Experimental
Arm Description
Each participant will receive 2.5 mg of rivaroxaban twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Each participant will receive matching placebo twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban
Intervention Description
Each participant, randomly allocated to the rivaroxaban arm, will receive one 2.5 mg tablet of rivaroxaban orally (by mouth) twice daily (once in the morning and once in the evening at approximately the same time each day) until the global treatment end date (GTED) (defined as the date when 1200 primary efficacy outcome events have occurred). Rivaroxaban will be given with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Each participant, randomly allocated to the placebo arm, will receive one matching placebo tablet orally twice daily (once in the morning and once in the evening at approximately the same time each day) until the GTED. Placebo will be given with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
Intervention Type
Other
Intervention Name(s)
Standard of care for heart failure and coronary artery disease
Intervention Description
Each participant's standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician) should be continued throughout the study.
Primary Outcome Measure Information:
Title
Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke
Description
Event Rate of all-cause mortality (ACM), MI, or stroke were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 patient [pt]-year [yr]) = 100*n/(total risk exposure), where n is the number of events.
Time Frame
Up to Global treatment end date (approximately 54 months)
Title
Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability
Description
Event rate of either fatal bleeding or bleeding into critical space with potential for permanent disability were assessed. Fatal bleeding event was death within 7 days after a bleeding event which required hospitalization or met International Society on Thrombosis and Haemostasis(ISTH) major bleeding definition criteria. Fatal bleeding events included those met criteria in 3 categories: 1: Any ISTH major bleeding event consider primary cause of death by investigator; 2: Any ISTH major bleeding event not considered to be primary cause of death by investigator but resulted in death within 7 days;3: Any bleeding event resulted in hospital stay and death within 7 days. Bleeding into critical space with potential for permanent disability included 7 critical spaces: intracranial, intraspinal, intraocular. Event rate estimated based on time to first occurrence of event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
Time Frame
Up to 227 Weeks
Secondary Outcome Measure Information:
Title
Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF)
Description
Event rate of cardio vascular (CV) death or re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
Time Frame
Up to Global treatment end date (approximately 54 months)
Title
Event Rate of Cardio Vascular Death
Description
Event rate of cardio vascular death were assessed. CV death included deaths due to spontaneous bleeding, MI, stroke, worsening HF and arrhythmias, death due to CV procedures and sudden death. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
Time Frame
Up to Global treatment end date (approximately 54 months)
Title
Event Rate of Re-Hospitalization for Worsening of Heart Failure
Description
Event rate of re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
Time Frame
Up to Global treatment end date (approximately 54 months)
Title
Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV)
Description
Event rate due to cardio vascular events were assessed. Hospitalization for a CV Event required that participants be hospitalized (in-patient or emergency department) for greater than 24 hours and must have met the following criterion:Discharge summary with primary reason for admission listed as CV in nature (example, bleeding, arrhythmia, ACS, MI) other than HF which was captured in the HF re-hospitalization. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
Time Frame
Up to Global treatment end date (approximately 54 months)
Title
Event Rate of All-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure
Description
Event rate of all-Cause Mortality (ACM) or re-Hospitalization for worsening heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
Time Frame
Up to Global treatment end date (approximately 54 months)
Title
Event Rate of Bleeding Events That Requiring Hospitalization
Description
Event rate of bleeding events and required Hospitalization were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
Time Frame
Up to 227 Weeks
Title
Event Rate of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding Event
Description
Event rate of ISTH major bleeding event were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.
Time Frame
Up to 227 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must have symptomatic heart failure for at least 3 months prior to Screening
Participants must have an episode of decompensated heart failure (index event) requiring (a) an overnight stay [that is, staying past midnight] in a hospital, emergency department, or medical facility with the capability of treating with intravenous medications and observing heart failure patients before randomization or (b) an unscheduled outpatient visit to a heart failure management center, where parenteral therapy is required for heart failure stabilization. An episode of decompensated heart failure is defined as symptoms of worsening dyspnea or fatigue, objective signs of congestion such as peripheral edema or ascites, and/or adjustment of pre-hospitalization/outpatient visit heart failure medications. Participants are eligible for randomization at discharge from the facility treating the index event and up to 30 days after discharge if they are in stable condition
Must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40 percent (%) within 1 year before randomization
Must have evidence of significant coronary artery disease
Must be medically stable in terms of their heart failure clinical status at the time of randomization
Must have a brain natriuretic peptide (BNP) level greater than or equal to (>=) 200 picogram per milliliter (pg/mL) or N-terminal-proBNP (NT-proBNP) level >=800 pg/mL (preferred assay) during the Screening period and before randomization
Exclusion Criteria:
Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, active internal bleeding, clinically significant bleeding, bleeding at a noncompressible site, or bleeding diathesis within 28 days of randomization
Severe concomitant disease such as (a) atrial fibrillation (AFib) or another condition that requires chronic anticoagulation (participants with isolated transient AFib may be allowed at the discretion of the treating physician investigator) and (b) Documented acute myocardial infarction (MI) during index event
Prior stroke within 90 days of randomization
Has been hospitalized for longer than 21 days during the index event
Planned intermittent outpatient treatment with positive inotropic drugs administered intravenously
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Alexander City
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Alabama
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Birmingham
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Alabama
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Mobile
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Anchorage
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Tucson
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Jonesboro
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Beverly Hills
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Chula Vista
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El Cajon
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Glendale
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Los Angeles
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Newport Beach
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Orange
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Stockton
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Torrance
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Denver
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New Haven
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Orlando
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Saint Petersburg
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Tallahassee
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Wellington
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Winter Haven
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Athens
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Atlanta
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Cumming
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Macon
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Tucker
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Chicago
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Evanston
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Hammond
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Shreveport
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Columbia
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Grand Blanc
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Mount Clemens
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Pontiac
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Elmer
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Haddon Heights
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Manalapan
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Ridgewood
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Sewell
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Albuquerque
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Buffalo
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Cortlandt Manor
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Jamaica
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Mineola
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New York
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Charlotte
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High Point
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Pinehurst
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Canton
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Cincinnati
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Columbus
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Dayton
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Fairfield
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Kettering
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Bartlesville
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Oklahoma City
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Tulsa
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Portland
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Doylestown
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Philadelphia
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Sayre
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Sellersville
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Wynnewood
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Yardley
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York
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Charleston
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Sioux Falls
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Nashville
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Cypress
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Dallas
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Fort Worth
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Houston
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Huntsville
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Kingwood
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Lubbock
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McKinney
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Burlington
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Vermont
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Newport News
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Virginia
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Bellingham
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Tacoma
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Huntington
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West Virginia
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Bahia Blanca
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Ciudad Autonoma de Buenos Aires
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Argentina
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Cordoba
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Argentina
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Córdoba
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Argentina
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La Plata
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Argentina
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Mar del Plata
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Argentina
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Mendoza
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Argentina
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Merlo
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Argentina
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Quilmes
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Argentina
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Resistencia
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Argentina
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Rosario
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Argentina
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San Miguel de Tucuman
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Argentina
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San Nicolas
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Argentina
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Santa Fe
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Argentina
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Santiago del Estero
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Argentina
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Tucuman
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Argentina
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Vicente Lopez
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Argentina
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Bedford
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Australia
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Cairns
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Australia
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Concord
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Australia
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Darlinghurst
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Australia
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Hobart
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Australia
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Launceston
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Australia
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Perth
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Australia
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Sydney
Country
Australia
City
Wollongong
Country
Australia
City
Woolloongabba
Country
Australia
City
Belo Horizonte
Country
Brazil
City
Belém
Country
Brazil
City
Blumenal
Country
Brazil
City
Brasília
Country
Brazil
City
Campina Grande do Sul
Country
Brazil
City
Campinas
Country
Brazil
City
Campo Grande
Country
Brazil
City
Canoas
Country
Brazil
City
Curitiba
Country
Brazil
City
Goiania
Country
Brazil
City
Goiânia
Country
Brazil
City
Marília
Country
Brazil
City
Passo Fundo
Country
Brazil
City
Porto Alegre
Country
Brazil
City
Recife
Country
Brazil
City
Ribeirão Preto
Country
Brazil
City
Rio de Janeiro
Country
Brazil
City
Salvador
Country
Brazil
City
São Jose do Rio Preto
Country
Brazil
City
São Paulo
Country
Brazil
City
São Pedro
Country
Brazil
City
Tatuí
Country
Brazil
City
Uberlândia
Country
Brazil
City
Votuporanga
Country
Brazil
City
Blagoevgrad
Country
Bulgaria
City
Burgas
Country
Bulgaria
City
Dimitrovgrad
Country
Bulgaria
City
Kazanlak
Country
Bulgaria
City
Pazardzhik
Country
Bulgaria
City
Pleven
Country
Bulgaria
City
Plovdiv
Country
Bulgaria
City
Ruse
Country
Bulgaria
City
Sofia
Country
Bulgaria
City
Stara Zagora
Country
Bulgaria
City
Varna
Country
Bulgaria
City
Veliko Tarnovo
Country
Bulgaria
City
Edmonton
State/Province
Alberta
Country
Canada
City
Maple Ridge
State/Province
British Columbia
Country
Canada
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
City
Halifax
State/Province
Nova Scotia
Country
Canada
City
Cambridge
State/Province
Ontario
Country
Canada
City
Kitchener
State/Province
Ontario
Country
Canada
City
London
State/Province
Ontario
Country
Canada
City
Ottawa
State/Province
Ontario
Country
Canada
City
Scarborough
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Montréal
State/Province
Quebec
Country
Canada
City
Baotou
Country
China
City
Beijing
Country
China
City
Changchun
Country
China
City
Changsha
Country
China
City
Chengdu
Country
China
City
Daqing
Country
China
City
Guangzhou
Country
China
City
Haikou
Country
China
City
Hangzhou
Country
China
City
Hunan
Country
China
City
Jinan
Country
China
City
Jining
Country
China
City
Lanzhou
Country
China
City
Nanchang
Country
China
City
Nanjing
Country
China
City
Nanning
Country
China
City
Qingdao
Country
China
City
Shanghai
Country
China
City
Shenyang
Country
China
City
Shijiazhuang
Country
China
City
Suzhou
Country
China
City
Taiyuan
Country
China
City
Tianjin
Country
China
City
Wuhan
Country
China
City
Xi'an
Country
China
City
Xian
Country
China
City
Yang Zhou
Country
China
City
Yichang
Country
China
City
Brno
Country
Czechia
City
Hodonín
Country
Czechia
City
Hradec Králové
Country
Czechia
City
Hranice
Country
Czechia
City
Karlovy Vary
Country
Czechia
City
Kladno
Country
Czechia
City
Kolín
Country
Czechia
City
Litomyšl
Country
Czechia
City
Mladá Boleslav
Country
Czechia
City
Olomouc
Country
Czechia
City
Plze?-Bory
Country
Czechia
City
Praha 10
Country
Czechia
City
Praha 8 - Libe?
Country
Czechia
City
Praha
Country
Czechia
City
Slany
Country
Czechia
City
Teplice
Country
Czechia
City
Uherské Hradišt?
Country
Czechia
City
Valašské Mezi?í?í
Country
Czechia
City
Esbjerg
Country
Denmark
City
Herlev
Country
Denmark
City
Hjørring
Country
Denmark
City
Hvidovre
Country
Denmark
City
Køge
Country
Denmark
City
Tallinn
Country
Estonia
City
Besancon
Country
France
City
Bron Cedex
Country
France
City
Chambray-Lès-Tours
Country
France
City
Corbeil Essonnes
Country
France
City
Lille
Country
France
City
Montpellier
Country
France
City
Nantes
Country
France
City
Nice
Country
France
City
Pau
Country
France
City
Rouen
Country
France
City
Toulouse
Country
France
City
Vandoeuvre-les-nancy
Country
France
City
Berlin
Country
Germany
City
Bielefeld
Country
Germany
City
Bonn
Country
Germany
City
Coburg
Country
Germany
City
Dresden
Country
Germany
City
Halle
Country
Germany
City
Hamburg
Country
Germany
City
Heidelberg
Country
Germany
City
Konstanz
Country
Germany
City
Langen
Country
Germany
City
Leipzig
Country
Germany
City
Ludwigshafen
Country
Germany
City
Magdeburg
Country
Germany
City
Mainz
Country
Germany
City
Markkleeberg
Country
Germany
City
Papenburg
Country
Germany
City
Stuttgart
Country
Germany
City
Ulm
Country
Germany
City
Witten
Country
Germany
City
Athens
Country
Greece
City
Heraklion -Crete
Country
Greece
City
Larisa
Country
Greece
City
Thessalonikis
Country
Greece
City
Voula
Country
Greece
City
Balatonfüred
Country
Hungary
City
Berettyóújfalu
Country
Hungary
City
Budapest
Country
Hungary
City
Gyor
Country
Hungary
City
Miskolc
Country
Hungary
City
Nagykanizsa
Country
Hungary
City
Szekszárd
Country
Hungary
City
Szolnok
Country
Hungary
City
Székesfehérvár
Country
Hungary
City
Zalaegerszeg
Country
Hungary
City
Aichi
Country
Japan
City
Chiba
Country
Japan
City
Chikushino-shi
Country
Japan
City
Ehime
Country
Japan
City
Fukuoka
Country
Japan
City
Gifu
Country
Japan
City
Gunma
Country
Japan
City
Hatsukaichi
Country
Japan
City
Hitachi
Country
Japan
City
Hokkaido
Country
Japan
City
Hyogo
Country
Japan
City
Ibaraki
Country
Japan
City
Ishikawa
Country
Japan
City
Izumo
Country
Japan
City
Kagawa
Country
Japan
City
Kahoku-District
Country
Japan
City
Kanagawa
Country
Japan
City
Kobe-shi
Country
Japan
City
Komatsushima-shi
Country
Japan
City
Koshigaya-shi
Country
Japan
City
Kumamoto
Country
Japan
City
Kyoto
Country
Japan
City
Miyazaki
Country
Japan
City
Nagano-shi
Country
Japan
City
Nagano
Country
Japan
City
Nagasaki
Country
Japan
City
Nagoya
Country
Japan
City
Niigata
Country
Japan
City
Oita
Country
Japan
City
Okayama
Country
Japan
City
Okinawa
Country
Japan
City
Osaka-shi
Country
Japan
City
Osaka
Country
Japan
City
Saga
Country
Japan
City
Saitama
Country
Japan
City
Sapporo
Country
Japan
City
Sendai
Country
Japan
City
Shiga
Country
Japan
City
Shimane
Country
Japan
City
Shizuoka
Country
Japan
City
Tachikawa
Country
Japan
City
Takaraduka
Country
Japan
City
Tochigi
Country
Japan
City
Tokushima
Country
Japan
City
Tokyo
Country
Japan
City
Toyama
Country
Japan
City
Toyoake
Country
Japan
City
Tsu
Country
Japan
City
Wakayama
Country
Japan
City
Yamaguchi
Country
Japan
City
Yatsushiro
Country
Japan
City
Yokohama
Country
Japan
City
Yonago
Country
Japan
City
Busan
Country
Korea, Republic of
City
Cheongju
Country
Korea, Republic of
City
Daegu
Country
Korea, Republic of
City
Daejeon
Country
Korea, Republic of
City
Gwangju
Country
Korea, Republic of
City
Seongnam-si
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Wonju
Country
Korea, Republic of
City
Daugavpils
Country
Latvia
City
Kuldiga
Country
Latvia
City
Liepaja
Country
Latvia
City
Riga
Country
Latvia
City
Sigulda
Country
Latvia
City
Ventspils
Country
Latvia
City
Alytus
Country
Lithuania
City
Kaunas
Country
Lithuania
City
Klaipeda
Country
Lithuania
City
Panevezys
Country
Lithuania
City
Siauliai
Country
Lithuania
City
Vilnius
Country
Lithuania
City
Cheras
Country
Malaysia
City
Johor Bahru
Country
Malaysia
City
Kota Kinabalu
Country
Malaysia
City
Kuala Lumpur
Country
Malaysia
City
Kuching
Country
Malaysia
City
Penang
Country
Malaysia
City
Selangor
Country
Malaysia
City
Selayang
Country
Malaysia
City
Aguascalientes
Country
Mexico
City
Benito Juárez
Country
Mexico
City
Chihuahua
Country
Mexico
City
Culiacan
Country
Mexico
City
Durango
Country
Mexico
City
Guadalajara
Country
Mexico
City
León
Country
Mexico
City
Mexico City
Country
Mexico
City
Mexico
Country
Mexico
City
Oaxaca
Country
Mexico
City
Pachuca
Country
Mexico
City
Puebla
Country
Mexico
City
Queretaro
Country
Mexico
City
San Luis Potosí
Country
Mexico
City
Tampico
Country
Mexico
City
Veracruz
Country
Mexico
City
Almere
Country
Netherlands
City
Amsterdam
Country
Netherlands
City
Blaricum
Country
Netherlands
City
Breda
Country
Netherlands
City
Deventer
Country
Netherlands
City
Doetinchem
Country
Netherlands
City
Ede
Country
Netherlands
City
Groningen
Country
Netherlands
City
Heerlen
Country
Netherlands
City
Helmond
Country
Netherlands
City
Maastricht
Country
Netherlands
City
Meppel
Country
Netherlands
City
Tilburg
Country
Netherlands
City
Będzin
Country
Poland
City
Gdynia
Country
Poland
City
Gliwice
Country
Poland
City
Grodzisk Mazowiecki
Country
Poland
City
Inowrocław
Country
Poland
City
Katowice
Country
Poland
City
Kielce
Country
Poland
City
Krakow
Country
Poland
City
Kraków
Country
Poland
City
Kutno
Country
Poland
City
Lodz
Country
Poland
City
Lubin
Country
Poland
City
Lublin
Country
Poland
City
Myslenice
Country
Poland
City
Olsztyn
Country
Poland
City
Ostroleka
Country
Poland
City
Ostrowiec Swietokrzyski
Country
Poland
City
Oswiecim
Country
Poland
City
Plock
Country
Poland
City
Pulawy
Country
Poland
City
Rabka-Zdrój
Country
Poland
City
Skierniewice
Country
Poland
City
Starogard Gdanski
Country
Poland
City
Szczecin
Country
Poland
City
Torun
Country
Poland
City
Warszawa
Country
Poland
City
Wloclawek
Country
Poland
City
Wrocław
Country
Poland
City
Zabrze
Country
Poland
City
Zamosc
Country
Poland
City
Łódż
Country
Poland
City
Almada
Country
Portugal
City
Aveiro
Country
Portugal
City
Braga
Country
Portugal
City
Carnaxide
Country
Portugal
City
Coimbra
Country
Portugal
City
Covilhã
Country
Portugal
City
Leiria
Country
Portugal
City
Lisboa
Country
Portugal
City
Matosinhos
Country
Portugal
City
Viana do Castelo
Country
Portugal
City
Vila Real
Country
Portugal
City
Bacau
Country
Romania
City
Baia Mare
Country
Romania
City
Braila
Country
Romania
City
Brasov
Country
Romania
City
Bucharest
Country
Romania
City
Bucuresti
Country
Romania
City
Buzau
Country
Romania
City
Cluj Napoca
Country
Romania
City
Cluj-Napoca
Country
Romania
City
Craiova
Country
Romania
City
Focsani
Country
Romania
City
Galati
Country
Romania
City
Iasi
Country
Romania
City
Oradea
Country
Romania
City
Pitesti
Country
Romania
City
Sibiu
Country
Romania
City
Targu Mures
Country
Romania
City
Targu-Mures
Country
Romania
City
Timisoara
Country
Romania
City
Arkhangelsk
Country
Russian Federation
City
Barnaul
Country
Russian Federation
City
Chita
Country
Russian Federation
City
Ekaterinburg
Country
Russian Federation
City
Ivanovo
Country
Russian Federation
City
Izhevsk
Country
Russian Federation
City
Kaluga
Country
Russian Federation
City
Kemerovo
Country
Russian Federation
City
Kirov
Country
Russian Federation
City
Krasnoyarsk
Country
Russian Federation
City
Kursk
Country
Russian Federation
City
Moscow, Zelenograd
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Nizhniy Novgorod
Country
Russian Federation
City
Nizhny Novgorod
Country
Russian Federation
City
Novosibirsk
Country
Russian Federation
City
Orenburg
Country
Russian Federation
City
Perm
Country
Russian Federation
City
Rostov on Don
Country
Russian Federation
City
Ryazan
Country
Russian Federation
City
Saint Petersburg
Country
Russian Federation
City
Samara
Country
Russian Federation
City
Saratov
Country
Russian Federation
City
Syktyvkar
Country
Russian Federation
City
Tomsk
Country
Russian Federation
City
Tyumen
Country
Russian Federation
City
Voronezh
Country
Russian Federation
City
Yaroslavl
Country
Russian Federation
City
Banska Bystrica
Country
Slovakia
City
Bardejov
Country
Slovakia
City
Kosice
Country
Slovakia
City
Lucenec
Country
Slovakia
City
Moldava nad Bodvou
Country
Slovakia
City
Nitra
Country
Slovakia
City
Povazska Bystrica
Country
Slovakia
City
Svidnik
Country
Slovakia
City
Bloemfontein
Country
South Africa
City
Cape Town
Country
South Africa
City
Centurion
Country
South Africa
City
Durban
Country
South Africa
City
Pinelands
Country
South Africa
City
Pretoria
Country
South Africa
City
Tongaat
Country
South Africa
City
A Coruña
Country
Spain
City
Alicante
Country
Spain
City
Almería
Country
Spain
City
Avila
Country
Spain
City
Barcelona
Country
Spain
City
Burgos
Country
Spain
City
Cáceres
Country
Spain
City
Elche
Country
Spain
City
Granada
Country
Spain
City
La Coruña
Country
Spain
City
Lorca
Country
Spain
City
Madrid
Country
Spain
City
Majadahonda
Country
Spain
City
Murcia
Country
Spain
City
Olot
Country
Spain
City
Orihuela
Country
Spain
City
Palma de Mallorca
Country
Spain
City
San Juan
Country
Spain
City
Sanlúcar de Barrameda
Country
Spain
City
Sant Joan Despí
Country
Spain
City
Santander
Country
Spain
City
Sevilla
Country
Spain
City
Terrassa
Country
Spain
City
Torrevieja
Country
Spain
City
Valencia
Country
Spain
City
Vigo
Country
Spain
City
Viladecans
Country
Spain
City
Falun
Country
Sweden
City
Jönköping
Country
Sweden
City
Ljungby
Country
Sweden
City
Stockholm
Country
Sweden
City
Uppsala
Country
Sweden
City
Ankara
Country
Turkey
City
Bursa
Country
Turkey
City
Diyarbakir
Country
Turkey
City
Eskisehir
Country
Turkey
City
Istanbul
Country
Turkey
City
Kahramanmaras
Country
Turkey
City
Kocaeli
Country
Turkey
City
Konya
Country
Turkey
City
Kırıkkale
Country
Turkey
City
Mersin
Country
Turkey
City
Sivas
Country
Turkey
City
Cherkassy
Country
Ukraine
City
Cherkasy
Country
Ukraine
City
Dnipro
Country
Ukraine
City
Donetsk
Country
Ukraine
City
Kharkiv
Country
Ukraine
City
Kyiv
Country
Ukraine
City
Lutsk
Country
Ukraine
City
Lviv
Country
Ukraine
City
Odesa
Country
Ukraine
City
Poltava
Country
Ukraine
City
Sumy
Country
Ukraine
City
Vinnitsa
Country
Ukraine
City
Vinnytsia
Country
Ukraine
City
Zaporizhzhia
Country
Ukraine
City
Zaporizhzhya
Country
Ukraine
City
Zhytomir
Country
Ukraine
City
Aberdeen
Country
United Kingdom
City
Airdrie
Country
United Kingdom
City
Birmingham
Country
United Kingdom
City
Chesterfield
Country
United Kingdom
City
Chichester
Country
United Kingdom
City
Clydebank
Country
United Kingdom
City
Cottingham
Country
United Kingdom
City
Dudley
Country
United Kingdom
City
Dundee
Country
United Kingdom
City
East Kilbride
Country
United Kingdom
City
Exeter
Country
United Kingdom
City
Inverness
Country
United Kingdom
City
Manchester
Country
United Kingdom
City
Ta1 5da
Country
United Kingdom
City
Wirral
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
33686472
Citation
Ferreira JP, Cleland JG, Lam CSP, Anker SD, Mehra MR, van Veldhuisen DJ, Byra WM, La Police DA, Pitt B, Greenberg B, Zannad F. Heart failure re-hospitalizations and subsequent fatal events in coronary artery disease: insights from COMMANDER-HF, EPHESUS, and EXAMINE. Clin Res Cardiol. 2021 Oct;110(10):1554-1563. doi: 10.1007/s00392-021-01830-1. Epub 2021 Mar 8.
Results Reference
derived
PubMed Identifier
33549557
Citation
Ferreira JP, Cleland JGF, Lam CSP, van Veldhuisen DJ, Byra WM, La Police DA, Anker SD, Mehra MR, Leroy C, Eschwege V, Toussaint-Hacquard M, Rossignol P, Greenberg B, Zannad F. Impact of Geographic Region on the COMMANDER-HF Trial. JACC Heart Fail. 2021 Mar;9(3):201-211. doi: 10.1016/j.jchf.2020.11.007. Epub 2021 Feb 3.
Results Reference
derived
PubMed Identifier
32171760
Citation
Cunningham JW, Ferreira JP, Deng H, Anker SD, Byra WM, Cleland JGF, Gheorghiade M, Lam CSP, La Police D, Mehra MR, Neaton JD, Spiro TE, van Veldhuisen DJ, Greenberg B, Zannad F. Natriuretic Peptide-Based Inclusion Criteria in a Heart Failure Clinical Trial: Insights From COMMANDER HF. JACC Heart Fail. 2020 May;8(5):359-368. doi: 10.1016/j.jchf.2019.12.009. Epub 2020 Mar 11.
Results Reference
derived
PubMed Identifier
31461239
Citation
Mehra MR, Vaduganathan M, Fu M, Ferreira JP, Anker SD, Cleland JGF, Lam CSP, van Veldhuisen DJ, Byra WM, Spiro TE, Deng H, Zannad F, Greenberg B. A comprehensive analysis of the effects of rivaroxaban on stroke or transient ischaemic attack in patients with heart failure, coronary artery disease, and sinus rhythm: the COMMANDER HF trial. Eur Heart J. 2019 Nov 21;40(44):3593-3602. doi: 10.1093/eurheartj/ehz427.
Results Reference
derived
PubMed Identifier
31017637
Citation
Greenberg B, Neaton JD, Anker SD, Byra WM, Cleland JGF, Deng H, Fu M, La Police DA, Lam CSP, Mehra MR, Nessel CC, Spiro TE, van Veldhuisen DJ, Vanden Boom CM, Zannad F. Association of Rivaroxaban With Thromboembolic Events in Patients With Heart Failure, Coronary Disease, and Sinus Rhythm: A Post Hoc Analysis of the COMMANDER HF Trial. JAMA Cardiol. 2019 Jun 1;4(6):515-523. doi: 10.1001/jamacardio.2019.1049.
Results Reference
derived
PubMed Identifier
30146935
Citation
Zannad F, Anker SD, Byra WM, Cleland JGF, Fu M, Gheorghiade M, Lam CSP, Mehra MR, Neaton JD, Nessel CC, Spiro TE, van Veldhuisen DJ, Greenberg B; COMMANDER HF Investigators. Rivaroxaban in Patients with Heart Failure, Sinus Rhythm, and Coronary Disease. N Engl J Med. 2018 Oct 4;379(14):1332-1342. doi: 10.1056/NEJMoa1808848. Epub 2018 Aug 27.
Results Reference
derived
Learn more about this trial
A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure
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