Clinical trial NCT02111564: A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients
Official title: Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Respiratory Insufficiency
Stroke Acute
Infectious Diseases
Rheumatic Diseases
Keywords: Heart Failure
Respiratory Insufficiency
Stroke Acute
Infectious Diseases
Rheumatic Diseases
Medically ill Patient
Rivaroxaban
Thromboembolism
Prophylactic Anti-Coagulation
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2014-04-11
Enrollment: 12024
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related death post-hospital discharge in high-risk, medically ill patients.

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), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect)-controlled, event-driven, multicenter study in patients who are hospitalized for a specific acute medical illness and have other risk factors for venous thromboembolism (VTE). The study is designed to evaluate rivaroxaban in the prevention of symptomatic VTE events and VTE-related deaths for a period of 45 days post-hospital discharge. The study will consist of a screening phase, a 45-day double-blind treatment phase, and a 30-day follow-up phase. Study drug will start at randomization (Day 1), and will continue until Day 45 (inclusive). A total of approximately 12000 patients will be randomly assigned to either rivaroxaban or placebo in a 1:1 ratio. The total duration for a patient who completes the study after randomization is expected to be 75 days.

Eligibility criteria: Key Inclusion Criteria:

* The duration of the index hospitalization must have been at least 3 and no more than 10 consecutive days
* Must meet venous thromboembolism (VTE) risk criteria with a total modified Improve VTE Risk Score of: greater than or equal 4, or 3 with D-dimer \> 2\* upper limit of normal (ULN), or 2 with D-dimer \> 2\*ULN

Key Exclusion Criteria:

* Any serious bleeding within 3 months prior to randomization or occurring during index hospitalization
* Serious trauma (including head trauma) within 4 weeks before randomization
* History of hemorrhagic stroke at any time in the past
* Any medical condition that requires chronic use of any parenteral or oral anticoagulation

Primary outcomes:
measure: Time From Randomization to First Occurrence of Composite of All Symptomatic Venous Thromboembolism (VTE) and VTE Related Death Adjudicated by Clinical Event Committee (CEC)
timeFrame: Up to Day 45
measure: Event Rate Based on Time From Randomization to the First Occurrence of Major Bleeding Adjudicated by CEC
timeFrame: From randomization to 2 days after the last dose (Day 45)
Secondary outcomes:
measure: Event Rate Based on Time From Randomization to First Occurrence of VTE-Related Death Adjudicated by CEC
timeFrame: Up to Day 45
measure: Event Rate Based on Time From Randomization to the First Occurrence of a Symptomatic Venous Thromboembolism Event (VTE) Adjudicated by CEC
timeFrame: Up to Day 45
measure: Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE and All-Cause Mortality (ACM) Adjudicated by CEC
timeFrame: Up to Day 45
measure: Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE, Myocardial Infarction (MI), Non-Hemorrhagic Stroke, and Cardiovascular (CV) Death Adjudicated by CEC
timeFrame: Up to Day 45
measure: Event Rate Based on Time From Randomization to First Occurrence of All-Cause Mortality (ACM) Adjudicated by CEC
timeFrame: Up to Day 45
Other outcomes:
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city: Saint Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Saratov
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Ulyanovsk
country: Russian Federation
city: Vsevolzhsk
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Belgrade
country: Serbia
city: Beograd
country: Serbia
city: Cacak
country: Serbia
city: Cuprija
country: Serbia
city: Dedinje
country: Serbia
city: Kragujevac
country: Serbia
city: Leskovac
country: Serbia
city: Nis
country: Serbia
city: Novi Sad
country: Serbia
city: Sabac
country: Serbia
city: Smederevo
country: Serbia
city: Sremska Kamenica
country: Serbia
city: Subotica
country: Serbia
city: Valjevo
country: Serbia
city: Vranje
country: Serbia
city: Zaječar
country: Serbia
city: Kosice
country: Slovakia
city: Martin
country: Slovakia
city: Nitra
country: Slovakia
city: Bellville
country: South Africa
city: Bloemfontein
country: South Africa
city: Cape Town
country: South Africa
city: Durban Kwa Zulu Natal
country: South Africa
city: Durban
country: South Africa
city: Gatesville Cape Town
country: South Africa
city: Groenkloof, Pretoria
country: South Africa
city: Johannesburg
country: South Africa
city: Kempton Park
country: South Africa
city: Kuils River
country: South Africa
city: Pretoria
country: South Africa
city: Somerset West
country: South Africa
city: Stellenbosch
country: South Africa
city: Worcester
country: South Africa
city: Alcalá de Henares
country: Spain
city: Alicante
country: Spain
city: Almeria
country: Spain
city: Alzira
country: Spain
city: Aranjuez
country: Spain
city: Avila
country: Spain
city: Balea
country: Spain
city: Barcelona
country: Spain
city: Burgos
country: Spain
city: Cartagena
country: Spain
city: Cáceres
country: Spain
city: Don Benito
country: Spain
city: Elche
country: Spain
city: Getafe
country: Spain
city: Granada
country: Spain
city: Huelva N/a
country: Spain
city: La Laguna
country: Spain
city: Las Palmas de Gran Canaria
country: Spain
city: Logroño
country: Spain
city: Madrid
country: Spain
city: Majadahonda-Madrid
country: Spain
city: Malaga
country: Spain
city: Murcia
country: Spain
city: Móstoles
country: Spain
city: Olot
country: Spain
city: Oviedo
country: Spain
city: Palma de Mallorca
country: Spain
city: Pamplona
country: Spain
city: Sabadell
country: Spain
city: San Sebastian de los Reyes
country: Spain
city: Sanchinarro
country: Spain
city: Sant Boi de Llobregat
country: Spain
city: Sant Joan d'Alacant
country: Spain
city: Santander N/a
country: Spain
city: Sarrià
country: Spain
city: Sevilla
country: Spain
city: Torrelavega Cantabria
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
city: Adana
country: Turkey
city: Ankara
country: Turkey
city: Antalya
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Konya
country: Turkey
city: Rize
country: Turkey
city: Samsun
country: Turkey
city: Cherkasy
country: Ukraine
city: Chernihiv
country: Ukraine
city: Dnipropetrovsk
country: Ukraine
city: Ivano-Frankivsky
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kherson
country: Ukraine
city: Kyiv
country: Ukraine
city: Lutsk
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
city: Poltava
country: Ukraine
city: Sumy
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Zaporizhzhia
country: Ukraine
city: Zaporizhzhya
country: Ukraine
city: Zhytomyr
country: Ukraine
city: Angus
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Craigavon
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Leeds
country: United Kingdom
city: Manchester
country: United Kingdom
city: Norwich
country: United Kingdom
city: Plymouth
country: United Kingdom
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Raskob GE, Spyropoulos AC, Zrubek J, Ageno W, Albers G, Elliott CG, Halperin J, Haskell L, Hiatt WR, Maynard GA, Peters G, Spiro T, Steg PG, Suh EY, Weitz JI. The MARINER trial of rivaroxaban after hospital discharge for medical patients at high risk of VTE. Design, rationale, and clinical implications. Thromb Haemost. 2016 Jun 2;115(6):1240-8. doi: 10.1160/TH15-09-0756. Epub 2016 Feb 4.
citation: Raskob GE, Ageno W, Albers G, Elliott CG, Halperin J, Maynard G, Steg PG, Weitz JI, Albanese J, Yuan Z, Levitan B, Lu W, Suh EY, Spiro T, Lipardi C, Barnathan ES, Spyropoulos AC. Benefit-Risk Assessment of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness. J Am Heart Assoc. 2022 Oct 18;11(20):e026229. doi: 10.1161/JAHA.122.026229. Epub 2022 Oct 7.
citation: Spyropoulos AC, Raskob GE, Cohen AT, Ageno W, Weitz JI, Spiro TE, Lu W, Lipardi C, Albers GW, Elliott CG, Halperin JL, Hiatt WR, Maynard G, Steg PG, Sugarmann C, Barnathan ES. Association of Bleeding Severity With Mortality in Extended Thromboprophylaxis of Medically Ill Patients in the MAGELLAN and MARINER Trials. Circulation. 2022 May 10;145(19):1471-1479. doi: 10.1161/CIRCULATIONAHA.121.057847. Epub 2022 Apr 7.
citation: Raskob GE, Spyropoulos AC, Spiro TE, Lu W, Yuan Z, Levitan B, Suh E, Barnathan ES. Benefit-Risk of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness: Pooled Analysis From MAGELLAN and MARINER. J Am Heart Assoc. 2021 Nov 16;10(22):e021579. doi: 10.1161/JAHA.121.021579. Epub 2021 Nov 10.
citation: Jamil A, Jamil U, Singh K, Khan F, Chi G. Extended Thromboprophylaxis With Betrixaban or Rivaroxaban for Acutely Ill Hospitalized Medical Patients: Meta-Analysis of Prespecified Subgroups. Crit Pathw Cardiol. 2021 Mar 1;20(1):16-24. doi: 10.1097/HPC.0000000000000232.
citation: Spyropoulos AC, Ageno W, Albers GW, Elliott CG, Halperin JL, Hiatt WR, Maynard GA, Steg PG, Weitz JI, Lu W, Spiro TE, Barnathan ES, Raskob GE. Post-Discharge Prophylaxis With Rivaroxaban Reduces Fatal and Major Thromboembolic Events in Medically Ill Patients. J Am Coll Cardiol. 2020 Jun 30;75(25):3140-3147. doi: 10.1016/j.jacc.2020.04.071.
citation: Weitz JI, Raskob GE, Spyropoulos AC, Spiro TE, De Sanctis Y, Xu J, Lu W, Suh E, Argenti D, Yang H, Albanese J, Lipardi C, Barnathan ES. Thromboprophylaxis with Rivaroxaban in Acutely Ill Medical Patients with Renal Impairment: Insights from the MAGELLAN and MARINER Trials. Thromb Haemost. 2020 Mar;120(3):515-524. doi: 10.1055/s-0039-1701009. Epub 2020 Jan 23.
citation: Spyropoulos AC, Ageno W, Albers GW, Elliott CG, Halperin JL, Hiatt WR, Maynard GA, Steg PG, Weitz JI, Suh E, Spiro TE, Barnathan ES, Raskob GE; MARINER Investigators. Rivaroxaban for Thromboprophylaxis after Hospitalization for Medical Illness. N Engl J Med. 2018 Sep 20;379(12):1118-1127. doi: 10.1056/NEJMoa1805090. Epub 2018 Aug 26.