Clinical trial NCT00571649: Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients
Official title: Multicenter, Randomized, Parallel-group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin. The MAGELLAN Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: Acute medical illnesses with increased risk for VTE.
Deep vein thrombosis (DVT)
Pulmonary embolism (PE),
Venous Thromboembolic disease (VTE),
Medical illness
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
First posted: 2007-12-12
Enrollment: 8101
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: This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.

Detailed description: The treatment period was followed by a follow-up period starting the day after the last intake of study medication, regardless of the actual duration of study drug administration and ended on Day 90 (+ 7 days). Participants who did not complete the treatment period also entered the follow-up period. It was also possible that participants did not enter the follow-up period, e.g. due to withdrawal of consent or termination of study participation.

Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor.

Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 40 years or more
* Patients at risk of venous thromboembolic events being hospitalized for acute medical conditions as follows:

  * Heart failure, New York Heart Association (NYHA) class III or IV
  * Active cancer
  * Acute ischemic stroke
  * Acute infectious and inflammatory diseases, including acute rheumatic diseases
  * Acute respiratory insufficiency
  * Additional risk factor for VTE, including reduced mobility

Exclusion Criteria:

* Conditions that contraindicate the use of antithrombotic therapy with the Low Molecular-Weight Heparin (LMWH) enoxaparin
* Conditions that may increase the risk of bleeding, including intracranial hemorrhage
* Required drugs or procedures which may interfere with the study treatment
* Concomitant conditions or diseases which may increase the risk of study subjects or interfere with the study outcome
* General conditions in which subjects are not suitable to participate in the study

Primary outcomes:
measure: Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days
timeFrame: Up to Day 35 + 6 days
measure: Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days
timeFrame: Up to Day 10 + 5 days
Secondary outcomes:
measure: Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and All-cause Mortality up to Day 35 + 6 Days
timeFrame: Up to Day 35 + 6 days
measure: Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days Per mITT Population
timeFrame: Up to Day 10 + 5 days
measure: Percentage of Participants With VTE Combined With All-cause Mortality up to Day 10 + 5 Days
timeFrame: Up to Day 10 + 5 days
measure: Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90
timeFrame: At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days
measure: Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 35 + 6 Days
timeFrame: Up to Day 35 + 6 days
measure: Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 10 + 5 Days
timeFrame: Up to Day 10 + 5 days
measure: Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90
timeFrame: At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days
measure: Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 35 + 6 Days
timeFrame: Up to Day 35 + 6 days
measure: Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days
timeFrame: Up to Day 10 + 5 days
measure: Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days
timeFrame: Up to Day 90 + 7 days
measure: Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Intake of Any Study Medication (Day 35 + 6 Days)
timeFrame: Up to Day 35 + 6 days
measure: Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Application of a Study Medication Syringe (Day 10 + 5 Days)
timeFrame: Up to Day 10 + 5 days
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Dothan
country: United States
state: Alabama
city: Geneva
country: United States
facility: Office of Dr. John Simmons, MD
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Tuscaloosa
country: United States
state: Alabama
city: Tuscaloosa
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Chula Vista
country: United States
state: California
city: Duarte
country: United States
state: California
city: Encinitas
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Fullerton
country: United States
state: California
city: Glendale
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Redlands
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Barbara
country: United States
state: California
city: Torrance
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Pueblo
country: United States
state: Colorado
city: Wheat Ridge
country: United States
state: Colorado
city: Farmington
country: United States
state: Connecticut
city: Newark
country: United States
state: Delaware
city: Washington
country: United States
state: District of Columbia
city: Aventura
country: United States
state: Florida
city: Boyton Beach
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Delray Beach
country: United States
state: Florida
city: Ft. Lauderdale
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Miami Springs
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Port Charlotte
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
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state: Georgia
city: Fort Gordon
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state: Georgia
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state: Idaho
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state: Illinois
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city: Noblesville
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state: Iowa
city: Olathe
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state: Kansas
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state: Louisiana
city: New Orleans
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city: Shreveport
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state: Maine
city: Rockport
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state: Michigan
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city: Detroit
country: United States
state: Michigan
city: Grand Rapids
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state: Michigan
city: Lansing
country: United States
state: Michigan
city: Petoskey
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state: Michigan
city: Pontiac
country: United States
state: Michigan
city: St. Clair Shores
country: United States
state: Michigan
city: Minneapolis
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state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
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city: Anaconda
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state: Montana
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city: Hackensack
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city: New Brunswick
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city: Teaneck
country: United States
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city: Buffalo
country: United States
state: New York
city: Jamaica
country: United States
state: New York
city: New Hyde Park
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Valhalla
country: United States
state: New York
city: Durham
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state: North Carolina
city: Elizabeth City
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Fargo
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state: North Dakota
city: Canton
country: United States
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city: Columbus
country: United States
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city: Maumee
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Bethlehem
country: United States
state: Pennsylvania
city: Camp Hill
country: United States
state: Pennsylvania
city: Danville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Scranton
country: United States
state: Pennsylvania
city: Wilkes-Barre
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Corsicana
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Edinburg
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Ogden
country: United States
state: Utah
city: Richmond
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Everett
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Clarksburg
country: United States
state: West Virginia
city: Avellaneda
country: Argentina
state: Buenos Aires
city: San Miguel
country: Argentina
state: Buenos Aires
city: Tres de Febrero
country: Argentina
facility: Hospital de Agudos "Dr. Carlos Bocalandro"
state: Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Británico
state: Ciudad Auton. de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Sanatorio Mitre
state: Ciudad Auton. de Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Vicente López
country: Argentina
city: Garran
country: Australia
state: Australian Capital Territory
city: Kogarah
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state: New South Wales
city: Lismore
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state: New South Wales
city: Sydney
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state: New South Wales
city: Auchenflower
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state: Queensland
city: Brisbane
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state: Queensland
city: Brisbane
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state: Queensland
city: Redcliffe
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state: Queensland
city: Southport
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state: Queensland
city: Woollongabba
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state: Queensland
city: Adelaide
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state: South Australia
city: Launceston
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state: Tasmania
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state: Victoria
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state: Victoria
city: Melbourne
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state: Victoria
city: Melbourne
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state: Victoria
city: Perth
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state: Western Australia
city: Kittsee
country: Austria
state: Burgenland
city: Oberpullendorf
country: Austria
state: Burgenland
city: Wolfsberg
country: Austria
state: Kärnten
city: Linz
country: Austria
state: Oberösterreich
city: Gratwein
country: Austria
state: Steiermark
city: Graz
country: Austria
state: Steiermark
city: Hartberg
country: Austria
state: Steiermark
city: Leoben
country: Austria
state: Steiermark
city: Zams
country: Austria
state: Tirol
city: Innsbruck
country: Austria
city: Linz
country: Austria
city: Mürzzuschlag
country: Austria
city: St. Pölten
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Aalst
country: Belgium
city: Brugge
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city: Bruxelles - Brussel
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city: Dendermonde
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city: Montigny S/sambre
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city: Mortsel
country: Belgium
city: Roeselare
country: Belgium
city: Sint-niklaas
country: Belgium
city: Tubize
country: Belgium
city: Turnhout
country: Belgium
city: Curitiba
country: Brazil
state: Parana
city: Porto Alegre
country: Brazil
state: Rio Grande do Sul
city: Campinas
country: Brazil
state: Sao Paulo
city: Santo Andre
country: Brazil
state: Sao Paulo
city: São Paulo
country: Brazil
state: Sao Paulo
city: São Paulo
country: Brazil
state: Sao Paulo
city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Pleven
country: Bulgaria
city: Ruse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Stara Zagora
country: Bulgaria
city: Varna
country: Bulgaria
city: Veliko Tarnovo
country: Bulgaria
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Saint John
country: Canada
state: New Brunswick
city: Cobourg
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Scarborough
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
facility: Hotel Dieu-Grace Hospital
state: Ontario
city: Greenfield Park
country: Canada
state: Quebec
city: Montreal
country: Canada
facility: CHUM - Hopital Notre-Dame
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Ste-Foy
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Quebec
country: Canada
city: Santiago
country: Chile
city: Santiago
country: Chile
city: Viña del Mar
country: Chile
city: Guangzhou
country: China
state: Guangdong
city: Guangzhou
country: China
state: Guangdong
city: Guangzhou
country: China
state: Guangdong
city: Changsha
country: China
state: Hunan
city: Nanjing
country: China
state: Jiangsu
city: Nanjing
country: China
state: Jiangsu
city: Changchun
country: China
state: Jilin
city: Dalian
country: China
state: Liaoning
city: Shenyang
country: China
state: Liaoning
city: Shenyang
country: China
state: Liaoning
city: Shenyang
country: China
state: Liaoning
city: Xi'an
country: China
facility: The 1st Affiliated Hosp of the 4th Military Med Uni
state: Shaanxi
city: Xi'an
country: China
facility: 1st Affiliated Hosp., Med College Xi'an Jiaotong Univ.
state: Shaanxi
city: Chengdu
country: China
state: Sichuan
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
facility: Beijing Friendship Hosp.
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Chongqing
country: China
city: Chongqing
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Medellín
country: Colombia
state: Antioquia
city: Bogotá
country: Colombia
state: Distrito Capital de Bogotá
city: Cali
country: Colombia
state: Valle del Cauca
city: Bogota
country: Colombia
city: Bogotá
country: Colombia
city: Cali
country: Colombia
city: Medellín
country: Colombia
city: Osijek
country: Croatia
city: Rijeka
country: Croatia
city: Zadar
country: Croatia
city: Zagreb
country: Croatia
city: Zagreb
country: Croatia
city: Brno
country: Czech Republic
city: Kutna Hora
country: Czech Republic
city: Nove Mesto na Morave
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Plzen
country: Czech Republic
city: Praha 2
country: Czech Republic
city: Praha 2
country: Czech Republic
city: Praha 2
country: Czech Republic
city: Ricany
country: Czech Republic
city: Znojmo
country: Czech Republic
city: Esbjerg
country: Denmark
city: Frederiksberg C
country: Denmark
city: Kolding
country: Denmark
city: København NV
country: Denmark
city: København S
country: Denmark
city: Roskilde
country: Denmark
city: Tallinn
country: Estonia
city: Tallinn
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city: Tallinn
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city: Tartu
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city: Raisio
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city: Turku
country: Finland
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city: Besancon
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city: Brest Cedex
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city: Castelnau Le Lez
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city: Clermont Ferrand
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city: Colombes Cedex
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city: Dijon
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city: Lille
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city: Lille
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city: Limoges
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city: Lomme
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city: Lyon
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city: Montpellier Cedex
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city: Nice
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city: Nimes
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city: Paris
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city: Paris
country: France
city: Paris
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city: Paris
country: France
city: Pierre Benite
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city: Reims
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city: Roubaix
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city: Saint Herblain Cedex
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city: Saint-etienne
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city: Strasbourg Cedex
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city: Toulouse
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city: TOURCOING cedex
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city: Vandoeuvre Les Nancy
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city: Bad Mergentheim
country: Germany
state: Baden-Württemberg
city: Esslingen
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state: Baden-Württemberg
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state: Baden-Württemberg
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state: Baden-Württemberg
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state: Bayern
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state: Brandenburg
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state: Brandenburg
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state: Nordrhein-Westfalen
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state: Nordrhein-Westfalen
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state: Nordrhein-Westfalen
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state: Nordrhein-Westfalen
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state: Nordrhein-Westfalen
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state: Nordrhein-Westfalen
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state: Nordrhein-Westfalen
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state: Nordrhein-Westfalen
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state: Nordrhein-Westfalen
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state: Nordrhein-Westfalen
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state: Nordrhein-Westfalen
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country: Germany
state: Nordrhein-Westfalen
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state: Nordrhein-Westfalen
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state: Nordrhein-Westfalen
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state: Rheinland-Pfalz
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country: Germany
state: Rheinland-Pfalz
city: Halle
country: Germany
state: Sachsen-Anhalt
city: Dresden
country: Germany
state: Sachsen
city: Dresden
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Pirna
country: Germany
state: Sachsen
city: Berlin
country: Germany
city: Bremen
country: Germany
city: Elefsina
country: Greece
state: Attica
city: Kifisia / Athens
country: Greece
state: Attica
city: Abelokipi - Athens
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city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Nea Ionia
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city: Piraeus
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city: Rio / Patras
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city: Shatin
country: Hong Kong
state: N.t.
city: Shatin
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country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
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city: Gyor
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city: Hodmezovasarhely
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city: Kecskemet
country: Hungary
city: Szekesfehervar
country: Hungary
city: Tatabanya
country: Hungary
city: Zalaegerszeg-Pozva
country: Hungary
city: Ahmedabad
country: India
state: Gujar?t
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country: India
state: Karn?taka
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country: India
state: Karn?taka
city: Calicut
country: India
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state: Punjab
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state: West Bengal
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city: Hyderabad
country: India
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country: India
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city: Noida
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city: Jakarta
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city: Jakarta
country: Indonesia
city: Surabaya
country: Indonesia
city: Afula
country: Israel
city: Ashkelon
country: Israel
city: Haifa
country: Israel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Kfar Saba
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
city: Zefat
country: Israel
city: Acquaviva delle Fonti
country: Italy
state: Bari
city: Napoli
country: Italy
state: Campania
city: Modena
country: Italy
state: Emilia-Romagna
city: Parma
country: Italy
state: Emilia-Romagna
city: Piacenza
country: Italy
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
state: Emilia-Romagna
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Genova
country: Italy
state: Liguria
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Varese
country: Italy
state: Lombardia
city: Campobasso
country: Italy
state: Molise
city: Fidenza
country: Italy
state: Parma
city: Catania
country: Italy
state: Sicilia
city: Palermo
country: Italy
state: Sicilia
city: Terni
country: Italy
state: Trentino-Alto Adige
city: Perugia
country: Italy
state: Umbria
city: Perugia
country: Italy
state: Umbria
city: Domodossola
country: Italy
state: Verbano-Cusio-Ossola
city: Bergamo
country: Italy
city: Latina
country: Italy
city: Reggio Calabria
country: Italy
city: Vicenza
country: Italy
city: Ichinomiya
country: Japan
state: Aichi
city: Kasugai
country: Japan
state: Aichi
city: Obu
country: Japan
state: Aichi
city: Matsuyama
country: Japan
state: Ehime
city: Toon
country: Japan
state: Ehime
city: Chikushino
country: Japan
state: Fukuoka
city: Takasaki
country: Japan
state: Gunma
city: Kure
country: Japan
state: Hiroshima
city: Hakodate
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Amagasaki
country: Japan
state: Hyogo
city: Kanazawa
country: Japan
state: Ishikawa
city: Hanamaki
country: Japan
state: Iwate
city: Ebina
country: Japan
state: Kanagawa
city: Kamakura
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Nangoku
country: Japan
state: Kochi
city: Matsusaka
country: Japan
state: Mie
city: Tsu
country: Japan
state: Mie
city: Tsu
country: Japan
state: Mie
city: Kashiwazaki
country: Japan
state: Niigata
city: Tomigusuku
country: Japan
state: Okinawa
city: Urasoe
country: Japan
state: Okinawa
city: Daito
country: Japan
state: Osaka
city: Yao
country: Japan
state: Osaka
city: Kusatsu
country: Japan
state: Shiga
city: Hamamatsu
country: Japan
state: Shizuoka
city: Meguro-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Shimonoseki
country: Japan
state: Yamaguchi
city: Fukui
country: Japan
city: Ibaraki
country: Japan
facility: National Hospital Organization Ibaraki Higashi Hospital
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Gyeongi-do
country: Korea, Republic of
state: Korea
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Boramae Hospital
state: Seoul Teugbyeolsi
city: Gyeonggi-do
country: Korea, Republic of
city: Jeollanam-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Daugavpils
country: Latvia
city: Liepaja
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Valmiera
country: Latvia
city: Ventspils
country: Latvia
city: Kaunas
country: Lithuania
city: Kaunas
country: Lithuania
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Klaipeda
country: Lithuania
city: Siauliai
country: Lithuania
city: Utena
country: Lithuania
city: Vilnius
country: Lithuania
city: Vilnius
country: Lithuania
city: Vilnius
country: Lithuania
city: Kirchberg
country: Luxembourg
city: Luxembourg
country: Luxembourg
city: Niederkorn
country: Luxembourg
city: Kuala Lumpur
country: Malaysia
city: Negeri Sembilan,
country: Malaysia
city: Sarawak
country: Malaysia
city: Tuxtla Gutiérrez
country: Mexico
state: Chiapas
city: Torreón
country: Mexico
state: Coahuila
city: Mexico D. F.
country: Mexico
state: Distrito Federal
city: Mexico D.F.
country: Mexico
state: Distrito Federal
city: Mexico D.F.
country: Mexico
state: Distrito Federal
city: México, D.F.
country: Mexico
state: Distrito Federal
city: México, D.F.
country: Mexico
state: Distrito Federal
city: México, D.F
country: Mexico
state: Distrito Federal
city: Guadalajara
country: Mexico
state: Jalisco
city: Morelia
country: Mexico
state: Michoacán
city: Metepec
country: Mexico
state: México
city: Monterrey
country: Mexico
state: Nuevo Leon
city: Hermosillo
country: Mexico
state: Sonora
city: Mérida
country: Mexico
state: Yucatán
city: Aguascalientes
country: Mexico
city: Chihuahua
country: Mexico
city: Puebla
country: Mexico
city: Zacatecas
country: Mexico
city: Amersfoort
country: Netherlands
city: Amsterdam
country: Netherlands
city: Enschede
country: Netherlands
city: Heerlen
country: Netherlands
city: Maastricht
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Rotterdam
country: Netherlands
city: Sittard
country: Netherlands
city: Utrecht
country: Netherlands
city: Auckland
country: New Zealand
city: Auckland
country: New Zealand
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Fredrikstad
country: Norway
city: Gjøvik
country: Norway
city: Hamar
country: Norway
city: Oslo
country: Norway
city: Oslo
country: Norway
city: Karachi
country: Pakistan
city: Karachi
country: Pakistan
city: Lahore
country: Pakistan
city: Callao
country: Peru
city: Lima Cercado
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Olsztyn
country: Poland
city: Piotrkow Trybunalski
country: Poland
city: Siedlce
country: Poland
city: Starogard Gdanski
country: Poland
city: Szczecin
country: Poland
city: Tarnów
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wloclawek
country: Poland
city: S. Martinho do Bispo
country: Portugal
state: Coimbra
city: Amadora
country: Portugal
city: Cascais
country: Portugal
city: Coimbra
country: Portugal
city: Lisboa
country: Portugal
city: Lisboa
country: Portugal
city: Lisboa
country: Portugal
city: Lisboa
country: Portugal
city: Matosinhos
country: Portugal
city: Porto
country: Portugal
city: Porto
country: Portugal
city: Santarém
country: Portugal
city: Viana do Castelo
country: Portugal
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Constanta
country: Romania
city: Suceava
country: Romania
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Lucenec
country: Slovakia
city: Martin
country: Slovakia
city: Zilina
country: Slovakia
city: Golnik
country: Slovenia
city: Ljubljana
country: Slovenia
city: Novo mesto
country: Slovenia
city: Bloemfontein
country: South Africa
state: Freestate
city: Johannesburg
country: South Africa
state: Gauteng
city: Johannesburg
country: South Africa
state: Gauteng
city: Johannesburg
country: South Africa
state: Gauteng
city: Kempton Park
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Roodepoort
country: South Africa
state: Gauteng
city: Goodwood
country: South Africa
state: Western Cape
city: Somerset West
country: South Africa
state: Western Cape
city: Stellenbosch
country: South Africa
state: Western Cape
city: Worcester
country: South Africa
state: Western Cape
city: Sandton, Gauteng
country: South Africa
city: Badalona
country: Spain
state: Barcelona
city: Sabadell
country: Spain
state: Barcelona
city: Cabra
country: Spain
state: Córdoba
city: Olot
country: Spain
state: Girona
city: Cartagena
country: Spain
state: Murcia
city: Vélez
country: Spain
state: Málaga
city: Vigo
country: Spain
state: Pontevedra
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Cuenca
country: Spain
city: Córdoba
country: Spain
city: Girona
country: Spain
city: Zaragoza
country: Spain
city: Borås
country: Sweden
city: Hässleholm
country: Sweden
city: Karlshamn
country: Sweden
city: Kristianstad
country: Sweden
city: Lund
country: Sweden
city: Malmö
country: Sweden
city: Skövde
country: Sweden
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
city: Sundsvall
country: Sweden
city: Umeå
country: Sweden
city: Visby
country: Sweden
city: Bruderholz
country: Switzerland
state: Basel-Landschaft
city: Basel
country: Switzerland
state: Basel-Stadt
city: Liestal
country: Switzerland
state: Basel-Stadt
city: Langenthal
country: Switzerland
state: Bern
city: Baden
country: Switzerland
city: Bern
country: Switzerland
city: Genève
country: Switzerland
city: Luzern
country: Switzerland
city: Zürich
country: Switzerland
city: Kaohsiung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Chiangmai
country: Thailand
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Izmir
country: Turkey
city: Donetsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
city: Odessa
country: Ukraine
city: Simferopol
country: Ukraine
city: Simferopol
country: Ukraine
city: Middlesborough
country: United Kingdom
state: Cleveland
city: Dumfries
country: United Kingdom
state: Dumfries and Galloway
city: Liverpool
country: United Kingdom
state: Merseyside
city: Sheffield
country: United Kingdom
state: South Yorkshire
city: Glasgow
country: United Kingdom
state: Stratchclyde
city: Newcastle Upon Tyne
country: United Kingdom
state: Tyne and Wear
city: Leeds
country: United Kingdom
state: West Yorkshire
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Nottingham
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Cohen AT, Spiro TE, Buller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Spyropoulos A, Tapson V. Extended-duration rivaroxaban thromboprophylaxis in acutely ill medical patients: MAGELLAN study protocol. J Thromb Thrombolysis. 2011 May;31(4):407-16. doi: 10.1007/s11239-011-0549-x.
citation: Cohen AT, Spiro TE, Buller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Spyropoulos AC, Tapson V; MAGELLAN Investigators. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013 Feb 7;368(6):513-23. doi: 10.1056/NEJMoa1111096.
citation: Sharma A, Chatterjee S, Lichstein E, Mukherjee D. Extended thromboprophylaxis for medically ill patients with decreased mobility: does it improve outcomes? J Thromb Haemost. 2012 Oct;10(10):2053-60. doi: 10.1111/j.1538-7836.2012.04874.x.
citation: Mebazaa A, Spiro TE, Buller HR, Haskell L, Hu D, Hull R, Merli G, Schellong SW, Spyropoulos AC, Tapson VF, De Sanctis Y, Cohen AT. Predicting the risk of venous thromboembolism in patients hospitalized with heart failure. Circulation. 2014 Jul 29;130(5):410-8. doi: 10.1161/CIRCULATIONAHA.113.003126. Epub 2014 Jun 26.
citation: Cohen AT, Spiro TE, Spyropoulos AC, Desanctis YH, Homering M, Buller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Tapson VF, Burton P; MAGELLAN Study Group. D-dimer as a predictor of venous thromboembolism in acutely ill, hospitalized patients: a subanalysis of the randomized controlled MAGELLAN trial. J Thromb Haemost. 2014 Apr;12(4):479-87. doi: 10.1111/jth.12515.
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: Raskob GE, Spyropoulos AC, Cohen AT, Weitz JI, Ageno W, De Sanctis Y, Lu W, Xu J, Albanese J, Sugarmann C, Weber T, Lipardi C, Spiro TE, Barnathan ES. Association Between Asymptomatic Proximal Deep Vein Thrombosis and Mortality in Acutely Ill Medical Patients. J Am Heart Assoc. 2021 Feb;10(5):e019459. doi: 10.1161/JAHA.120.019459. Epub 2021 Feb 15.
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: 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: Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM. Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis. J Thromb Haemost. 2017 Oct;15(10):1913-1922. doi: 10.1111/jth.13783. Epub 2017 Sep 4.
citation: Marszalek J, Mehrsefat S, Chi G. The risk of stroke among acutely ill hospitalized medical patients: lessons from recent trials on extended-duration thromboprophylaxis. Expert Rev Hematol. 2017 Aug;10(8):679-684. doi: 10.1080/17474086.2017.1343662. Epub 2017 Jun 21.