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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01877915




Registration number
NCT01877915
Ethics application status
Date submitted
12/06/2013
Date registered
14/06/2013
Date last updated
10/05/2019

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
RIVAROXHFA3001
Secondary ID [2] 0 0
CR101940
Universal Trial Number (UTN)
Trial acronym
COMMANDER HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban
Treatment: Drugs - Placebo
Other interventions - Standard of care for heart failure and coronary artery disease

Experimental: Rivaroxaban 2.5 mg - 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).

Placebo Comparator: Placebo - 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).


Treatment: Drugs: Rivaroxaban
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).

Treatment: Drugs: Placebo
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).

Other interventions: Standard of care for heart failure and coronary artery disease
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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke
Timepoint [1] 0 0
Up to Global treatment end date (approximately 54 months)
Primary outcome [2] 0 0
Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability
Timepoint [2] 0 0
Up to 227 Weeks
Secondary outcome [1] 0 0
Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF)
Timepoint [1] 0 0
Up to Global treatment end date (approximately 54 months)
Secondary outcome [2] 0 0
Event Rate of Cardio Vascular Death
Timepoint [2] 0 0
Up to Global treatment end date (approximately 54 months)
Secondary outcome [3] 0 0
Event Rate of Re-Hospitalization for Worsening of Heart Failure
Timepoint [3] 0 0
Up to Global treatment end date (approximately 54 months)
Secondary outcome [4] 0 0
Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV)
Timepoint [4] 0 0
Up to Global treatment end date (approximately 54 months)
Secondary outcome [5] 0 0
Event Rate of All-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure
Timepoint [5] 0 0
Up to Global treatment end date (approximately 54 months)
Secondary outcome [6] 0 0
Event Rate of Bleeding Events That Requiring Hospitalization
Timepoint [6] 0 0
Up to 227 Weeks
Secondary outcome [7] 0 0
Event Rate of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding Event
Timepoint [7] 0 0
Up to 227 Weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
95 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/04/2018
Sample size
Target
Accrual to date
Final
5081
Recruitment in Australia
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- Sydney
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- Woolloongabba
Recruitment outside Australia
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country
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Bayer
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Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01877915
Trial related presentations / publications
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Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical Trial
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Janssen Research & Development, LLC
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