Clinical trial NCT01877915: 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
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Coronary Artery Disease
Keywords: Heart Failure
Coronary Artery Disease
Stroke
Myocardial Infarction
Anticoagulation
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2013-06-14
Enrollment: 5081
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke
timeFrame: Up to Global treatment end date (approximately 54 months)
measure: Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability
timeFrame: Up to 227 Weeks
Secondary outcomes:
measure: Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF)
timeFrame: Up to Global treatment end date (approximately 54 months)
measure: Event Rate of Cardio Vascular Death
timeFrame: Up to Global treatment end date (approximately 54 months)
measure: Event Rate of Re-Hospitalization for Worsening of Heart Failure
timeFrame: Up to Global treatment end date (approximately 54 months)
measure: Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV)
timeFrame: Up to Global treatment end date (approximately 54 months)
measure: Event Rate of All-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure
timeFrame: Up to Global treatment end date (approximately 54 months)
measure: Event Rate of Bleeding Events That Requiring Hospitalization
timeFrame: Up to 227 Weeks
measure: Event Rate of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding Event
timeFrame: Up to 227 Weeks
Other outcomes:
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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
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.