Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)

NCT ID: NCT01583218

Last Updated: 2023-08-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

7513 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-01-31

Brief Summary

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The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. The safety of betrixaban will also be studied.

Detailed Description

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Conditions

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Venous Thromboembolism (VTE)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Betrixaban

Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days

Group Type EXPERIMENTAL

Betrixaban

Intervention Type DRUG

Betrixaban 80 mg PO once daily (QD) for 35 day + 7 days.

Enoxaparin Placebo: Once daily, 6-14 days

Enoxaparin

Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

Enoxaparin 40 mg subcutaneous (SC) QD for 10 ± 4 days.

Betrixaban Placebo: once daily, 35 days

Interventions

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Betrixaban

Betrixaban 80 mg PO once daily (QD) for 35 day + 7 days.

Enoxaparin Placebo: Once daily, 6-14 days

Intervention Type DRUG

Enoxaparin

Enoxaparin 40 mg subcutaneous (SC) QD for 10 ± 4 days.

Betrixaban Placebo: once daily, 35 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* men and non-pregnant, non-breastfeeding women
* anticipated to be severely immobilized for at least 24 hours after randomization
* hospitalized with one of the following

* congestive heart failure
* acute respiratory failure,
* acute infection without septic shock,
* acute rheumatic disorders
* acute ischemic stroke with lower extremity hemiparesis or hemi paralysis

Exclusion Criteria

* a condition requiring prolonged anticoagulation or anti-platelets
* active bleeding or at high risk of bleeding
* contraindication to anticoagulant therapy
* general conditions in which subjects are not suitable to participate in the study
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Portola Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Birmingham, Alabama, United States

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Bakersfield, California, United States

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Fresno, California, United States

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La Mesa, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Modesto, California, United States

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San Diego, California, United States

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Stanford, California, United States

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Torrance, California, United States

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Englewood, Colorado, United States

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Bay Pines, Florida, United States

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Clearwater, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Pensacola, Florida, United States

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Sarasota, Florida, United States

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Vero Beach, Florida, United States

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Columbus, Georgia, United States

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Decatur, Georgia, United States

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Chicago, Illinois, United States

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Oak Park, Illinois, United States

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Carmel, Indiana, United States

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Davenport, Iowa, United States

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Windsor Heights, Iowa, United States

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Topeka, Kansas, United States

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Hazard, Kentucky, United States

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Annapolis, Maryland, United States

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Baltimore, Maryland, United States

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Detroit, Michigan, United States

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Grand Blanc, Michigan, United States

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Royal Oak, Michigan, United States

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Troy, Michigan, United States

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Duluth, Minnesota, United States

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Picayune, Mississippi, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Butte, Montana, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Atlantic City, New Jersey, United States

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Pomona, New Jersey, United States

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Somerville, New Jersey, United States

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Summit, New Jersey, United States

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Buffalo, New York, United States

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Manhasset, New York, United States

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Staten Island, New York, United States

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Valhalla, New York, United States

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Durham, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Camp Hill, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Orangeburg, South Carolina, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Bellaire, Texas, United States

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Corsicana, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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McAllen, Texas, United States

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Mission, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Victoria, Texas, United States

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Colchester, Vermont, United States

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Charlottesville, Virginia, United States

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Richmond, Virginia, United States

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Everett, Washington, United States

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Huntington, West Virginia, United States

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Coronel Suarez, Buenos Aires, , Argentina

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Corrientes, , Argentina

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Córdoba, , Argentina

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El Talar, , Argentina

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Rosario, Santa Fe, , Argentina

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San Miguel de Tucumán, , Argentina

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Redcliffe, Queensland, Australia

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Bedford Park, South Australia, Australia

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Nedlands, Western Australia, Australia

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Milton, , Australia

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Parkville, , Australia

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Randwick, , Australia

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Richmond, , Australia

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Feldkirch, , Austria

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Gratwein, , Austria

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Graz, , Austria

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Hartberg, , Austria

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Linz, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Zams, , Austria

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Brussels, , Belgium

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Huy, , Belgium

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Leper, , Belgium

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Leuven, , Belgium

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Yvoir, , Belgium

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Belo Horizonte - MG, , Brazil

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Botucatu, , Brazil

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Brasilia/DF, , Brazil

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Brasília, , Brazil

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Campinas, , Brazil

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Campinas, Sao Paulo, , Brazil

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Curitiba - PR, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre/RS, , Brazil

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Salvador, , Brazil

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Salvador/BA, , Brazil

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Salvador/BA, , Brazil

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São José Do Rio Preto- SP, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Gabrovo, , Bulgaria

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Sandanski, , Bulgaria

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Sliven, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Yambol, , Bulgaria

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Edmonton, Alberta, Canada

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Halifax, Nova Scotia, Canada

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Hamilton, Ontario, Canada

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Hamilton, Ontario, Canada

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Kitchener, Ontario, Canada

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Ottawa, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Montreal, Quebec, Canada

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Ontario, , Canada

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Québec, , Canada

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La Serena, , Chile

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Osorno, , Chile

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Santiago, , Chile

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Santiago, , Chile

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Temuco, , Chile

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Viña del Mar, , Chile

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Krapinske Toplice, , Croatia

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Pula, , Croatia

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Rijeka, , Croatia

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Varaždin, , Croatia

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Zadar, , Croatia

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Zagreb, , Croatia

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Zagreb, , Croatia

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Chrudim, , Czechia

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Čáslav, , Czechia

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Hradec Králové, , Czechia

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Kladno, , Czechia

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Kroměříž, , Czechia

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Kyjov, , Czechia

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Liberec, , Czechia

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Litomyšl, , Czechia

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Olomouc, , Czechia

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Ostrava, , Czechia

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Plzen - Bory, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Slaný, , Czechia

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Strakonice, , Czechia

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Teplice, , Czechia

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Ústí nad Labem, , Czechia

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Zlín, , Czechia

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Znojmo, , Czechia

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Aarhus N, , Denmark

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Frederiksberg, , Denmark

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Glostrup Municipality, , Denmark

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Haderslev, , Denmark

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Hellerup, , Denmark

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Hillerød, , Denmark

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Hvidovre, , Denmark

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København NV, , Denmark

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Silkeborg, , Denmark

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Slagelse, , Denmark

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Tallinn, , Estonia

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Tallinn, , Estonia

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Tartu, , Estonia

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Helsinki, , Finland

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Jyväskylä, , Finland

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Kouvola, , Finland

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Mikkeli, , Finland

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Pori, , Finland

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Tampere, , Finland

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Turku, , Finland

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Angers, , France

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Arras, , France

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Avignon, , France

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Bois-Guillaume, , France

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Bordeaux, , France

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Brest, , France

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Brest, , France

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Cambrai, , France

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Castelnau-le-Lez, , France

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Clermont-Ferrand, , France

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Colombes, , France

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Dijon, , France

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La Tronche, , France

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Le Mans, , France

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Lille, , France

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Limoges, , France

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Montpellier, , France

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Nantes, , France

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Nîmes, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Pierre-Bénite, , France

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Quimper, , France

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Rennes, , France

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Saint-Priest En Jarrez, , France

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Tourcoing, , France

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Valenciennes, , France

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Vernon, , France

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Altenburg, , Germany

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Bad Friedrichshall, , Germany

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Berlin, , Germany

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Bonn, , Germany

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Dresden, , Germany

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Dresden, , Germany

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Essen, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Karlbad, , Germany

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Ludwigshafen, , Germany

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Magdeburg, , Germany

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Mainz, , Germany

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Minden, , Germany

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Möchengladbach, , Germany

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Neuss, , Germany

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Oberhausen, , Germany

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Paderborn, , Germany

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Rüsselsheim am Main, , Germany

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Troisdorf, , Germany

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Weiden, , Germany

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Wesel, , Germany

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Wiesbaden, , Germany

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Witten, , Germany

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Baja, , Hungary

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Balassagyarmat, , Hungary

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Balatonfüred, , Hungary

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Berettyóújfalu, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Cegléd, , Hungary

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Debrecen, , Hungary

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Debrecen, , Hungary

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Eger, , Hungary

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Gyula, , Hungary

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Hódmezövásárhely, , Hungary

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Kistarcsa, , Hungary

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Mohács, , Hungary

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Nagykanizsa, , Hungary

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Szekszárd, , Hungary

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Szolnok, , Hungary

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Veszprém, , Hungary

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Zalaegerszeg, , Hungary

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Afula, , Israel

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Ashkelon, , Israel

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Haifa, , Israel

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Haifa, , Israel

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Jerusalem, , Israel

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Kfar Saba, , Israel

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Petah Tikva, , Israel

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Safed, , Israel

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Tel Aviv, , Israel

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Ẕerifin, , Israel

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Castelfranco Veneto, Treviso, Italy

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Bollate, , Italy

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Frenze, , Italy

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Genova, , Italy

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Milan, , Italy

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Milan, , Italy

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Napoli, , Italy

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Parma, , Italy

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Pavia, , Italy

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Piacenza, , Italy

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Reggio Emilia, , Italy

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Roma, , Italy

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Varese, , Italy

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Venezia, , Italy

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Vittorio Veneto TV, , Italy

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Daugavpils, , Latvia

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Liepāja, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Valmiera, , Latvia

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Alytus, , Lithuania

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Kaunas, , Lithuania

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Kaunas, , Lithuania

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Kaunas, , Lithuania

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Klaipėda, , Lithuania

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Klaipėda, , Lithuania

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Šiauliai, , Lithuania

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Utena, , Lithuania

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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Picayune, MS, Montserrat

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Arequipa, , Peru

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Callao, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Bialystok, , Poland

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Bydgoszcz, , Poland

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Bydgoszcz, , Poland

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Czeladź, , Poland

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Gdansk, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Skierniewice, , Poland

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Tarnobrzeg, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Włocławek, , Poland

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Baia, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Cluj-Napoca, , Romania

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Craiova, , Romania

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Iași, , Romania

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Oradea, , Romania

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Piteşti, , Romania

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Târgu Mureş, , Romania

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Timișoara, , Romania

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Arkhangelsk, , Russia

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Barnaul, , Russia

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Barnaul, , Russia

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Belgorod, , Russia

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Chelyabinsk, , Russia

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Chelyabinsk, , Russia

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Irkutsk, , Russia

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Kaluga, , Russia

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Kazan', , Russia

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Kazan', , Russia

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Kemerovo, , Russia

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Kirov, , Russia

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Krasnodar, , Russia

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Lubertsy, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Murmansk, , Russia

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Novosibirsk, , Russia

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Novosibirsk, , Russia

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Novosibirsk, , Russia

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Rostov-on-Don, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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Saratov, , Russia

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Saratov, , Russia

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Saratov, , Russia

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Smolensk, , Russia

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Tomsk, , Russia

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Yaroslavl, , Russia

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Yaroslavl, , Russia

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Yekaterinburg, , Russia

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Yekaterinburg, , Russia

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Belgrade, , Serbia

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Kamenitz, , Serbia

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Kragujevac, , Serbia

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Niš, , Serbia

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Niška Banja, , Serbia

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Pančevo, , Serbia

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Singapore, , Singapore

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Singapore, , Singapore

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Singapore, , Singapore

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Bratislava, , Slovakia

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Nitra, , Slovakia

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Nitra, , Slovakia

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Johannesburg, Gauteng, South Africa

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Johannesburg, Gauteng, South Africa

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Cape Town, Western Cape, South Africa

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Pretoria, , South Africa

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Worcester, , South Africa

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Barcelona, Catalonia, Spain

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Barcelona, Catalonia, Spain

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L'Hospitalet de Llobregat, Catalonia, Spain

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Sabadell, Catalonia, Spain

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Sant Boi de Llobregat, Catalonia, Spain

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Tarragona, Catalonia, Spain

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Madrid, Communidad de, Spain

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Vigo, Galicia, Spain

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Madrid, Madrid, Communidad de, Spain

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Majadahonda, Madrid, Communidad de, Spain

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San Sebastián de los Reyes, Madrid, Communidad de, Spain

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Orihuela, Valencia, Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Cartagena, , Spain

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Girona, , Spain

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Olot, , Spain

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Pontevedra, , Spain

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Salamanca, , Spain

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Terrassa, , Spain

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Donetsk, , Ukraine

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Donetsk, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Kharkiv, , Ukraine

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Kharkiv, , Ukraine

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Kharkiv, , Ukraine

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Kharkiv, , Ukraine

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Kherson, , Ukraine

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Kirovograd, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Luhansk, , Ukraine

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Lutsk, , Ukraine

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Lviv, , Ukraine

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Odesa, , Ukraine

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Odesa, , Ukraine

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Odesa, , Ukraine

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Rivne, , Ukraine

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Simferopol, , Ukraine

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Uzhhorod, , Ukraine

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Vinnytsia, , Ukraine

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Yevpatoria, , Ukraine

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Zaporizhzhya, , Ukraine

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Zaporizhzhya, , Ukraine

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Romford, , United Kingdom

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Southall, , United Kingdom

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Countries

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United States Argentina Australia Austria Belgium Brazil Bulgaria Canada Chile Croatia Czechia Denmark Estonia Finland France Georgia Germany Hungary Israel Italy Latvia Lithuania Montserrat Peru Poland Romania Russia Serbia Singapore Slovakia South Africa Spain Ukraine United Kingdom

References

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Chi G, Violi F, Pignatelli P, Vestri A, Spagnoli A, Loffredo L, Hernandez AF, Hull RD, Cohen AT, Harrington RA, Goldhaber SZ, Gibson CM. External validation of the ADA score for predicting thrombosis among acutely ill hospitalized medical patients from the APEX Trial. J Thromb Thrombolysis. 2023 Feb;55(2):211-221. doi: 10.1007/s11239-022-02757-8. Epub 2022 Dec 24.

Reference Type DERIVED
PMID: 36566304 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32657973 (View on PubMed)

Yee MK, Gibson CM, Nafee T, Kerneis M, Daaboul Y, Korjian S, Chi G, AlKhalfan F, Hernandez AF, Hull RD, Cohen AT, Goldhaber SZ. Characterization of Major and Clinically Relevant Non-Major Bleeds in the APEX Trial. TH Open. 2019 Apr 17;3(2):e103-e108. doi: 10.1055/s-0039-1685496. eCollection 2019 Apr.

Reference Type DERIVED
PMID: 31249989 (View on PubMed)

Guy H, Laskier V, Fisher M, Bucior I, Deitelzweig S, Cohen AT. Budget impact analysis of betrixaban for venous thromboembolism prophylaxis in nonsurgical patients with acute medical illness in the United Kingdom. Expert Rev Pharmacoecon Outcomes Res. 2020 Jun;20(3):259-267. doi: 10.1080/14737167.2019.1629905. Epub 2019 Jun 19.

Reference Type DERIVED
PMID: 31215264 (View on PubMed)

Chi G, Gibson CM, Kalayci A, Cohen AT, Hernandez AF, Hull RD, Kahe F, Jafarizade M, Sharfaei S, Liu Y, Harrington RA, Goldhaber SZ. Extended-duration betrixaban versus shorter-duration enoxaparin for venous thromboembolism prophylaxis in critically ill medical patients: an APEX trial substudy. Intensive Care Med. 2019 Apr;45(4):477-487. doi: 10.1007/s00134-019-05565-6. Epub 2019 Feb 18.

Reference Type DERIVED
PMID: 30778649 (View on PubMed)

Kalayci A, Gibson CM, Chi G, Yee MK, Korjian S, Datta S, Nafee T, Gurin M, Haroian N, Qamar I, Hull RD, Hernandez AF, Cohen AT, Harrington RA, Goldhaber SZ. Asymptomatic Deep Vein Thrombosis is Associated with an Increased Risk of Death: Insights from the APEX Trial. Thromb Haemost. 2018 Dec;118(12):2046-2052. doi: 10.1055/s-0038-1675606. Epub 2018 Nov 12.

Reference Type DERIVED
PMID: 30419597 (View on PubMed)

Chi G, Gibson CM, Liu Y, Hernandez AF, Hull RD, Cohen AT, Harrington RA, Goldhaber SZ. Inverse relationship of serum albumin to the risk of venous thromboembolism among acutely ill hospitalized patients: Analysis from the APEX trial. Am J Hematol. 2019 Jan;94(1):21-28. doi: 10.1002/ajh.25296. Epub 2018 Oct 17.

Reference Type DERIVED
PMID: 30252149 (View on PubMed)

Chi G, Goldhaber SZ, Hull RD, Hernandez AF, Kerneis M, Al Khalfan F, Cohen AT, Harrington RA, Gibson CM. Thrombus Burden of Deep Vein Thrombosis and Its Association with Thromboprophylaxis and D-Dimer Measurement: Insights from the APEX Trial. Thromb Haemost. 2017 Dec;117(12):2389-2395. doi: 10.1160/TH17-08-0538. Epub 2017 Dec 6.

Reference Type DERIVED
PMID: 29212126 (View on PubMed)

Yee MK, Nafee T, Daaboul Y, Korjian S, AlKhalfan F, Kerneis M, Wiest C, Goldhaber SZ, Hernandez AF, Hull RD, Cohen AT, Harrington RA, Gibson CM. Increased benefit of betrixaban among patients with a history of venous thromboembolism: a post-hoc analysis of the APEX trial. J Thromb Thrombolysis. 2018 Jan;45(1):1-8. doi: 10.1007/s11239-017-1583-0.

Reference Type DERIVED
PMID: 29188425 (View on PubMed)

Chi G, Januzzi JL, Korjian S, Daaboul Y, Goldhaber SZ, Hernandez AF, Hull RD, Gold A, Cohen AT, Harrington RA, Gibson CM. N-terminal pro-B-type natriuretic peptide and the risk of stroke among patients hospitalized with acute heart failure: an APEX trial substudy. J Thromb Thrombolysis. 2017 Nov;44(4):457-465. doi: 10.1007/s11239-017-1552-7.

Reference Type DERIVED
PMID: 28905172 (View on PubMed)

Arbetter DF, Jain P, Yee MK, Michalak N, Hernandez AF, Hull RD, Goldhaber SZ, Harrington RA, Gold A, Cohen AT, Gibson CM. Competing risk analysis in a large cardiovascular clinical trial: An APEX substudy. Pharm Stat. 2017 Nov;16(6):445-450. doi: 10.1002/pst.1823. Epub 2017 Aug 24.

Reference Type DERIVED
PMID: 28840662 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28762617 (View on PubMed)

Gibson CM, Korjian S, Chi G, Daaboul Y, Jain P, Arbetter D, Goldhaber SZ, Hull R, Hernandez AF, Lopes RD, Gold A, Cohen AT, Harrington RA; APEX Investigators. Comparison of Fatal or Irreversible Events With Extended-Duration Betrixaban Versus Standard Dose Enoxaparin in Acutely Ill Medical Patients: An APEX Trial Substudy. J Am Heart Assoc. 2017 Jul 11;6(7):e006015. doi: 10.1161/JAHA.117.006015.

Reference Type DERIVED
PMID: 28698258 (View on PubMed)

Gibson CM, Goldhaber SZ, Cohen AT, Nafee T, Hernandez AF, Hull R, Korjian S, Daaboul Y, Chi G, Yee M, Harrington RA. When academic research organizations and clinical research organizations disagree: Processes to minimize discrepancies prior to unblinding of randomized trials. Am Heart J. 2017 Jul;189:1-8. doi: 10.1016/j.ahj.2017.03.018. Epub 2017 Mar 31. No abstract available.

Reference Type DERIVED
PMID: 28625365 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28617144 (View on PubMed)

Gibson CM, Chi G, Halaby R, Korjian S, Daaboul Y, Jain P, Arbetter D, Goldhaber SZ, Hull R, Hernandez AF, Gold A, Bandman O, Harrington RA, Cohen AT; APEX Investigators. Extended-Duration Betrixaban Reduces the Risk of Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically Ill Patients: An APEX Trial Substudy (Acute Medically Ill Venous Thromboembolism Prevention With Extended Duration Betrixaban). Circulation. 2017 Feb 14;135(7):648-655. doi: 10.1161/CIRCULATIONAHA.116.025427. Epub 2016 Nov 14.

Reference Type DERIVED
PMID: 27881569 (View on PubMed)

Cohen AT, Harrington RA, Goldhaber SZ, Hull RD, Wiens BL, Gold A, Hernandez AF, Gibson CM; APEX Investigators. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients. N Engl J Med. 2016 Aug 11;375(6):534-44. doi: 10.1056/NEJMoa1601747. Epub 2016 May 27.

Reference Type DERIVED
PMID: 27232649 (View on PubMed)

Cohen AT, Harrington R, Goldhaber SZ, Hull R, Gibson CM, Hernandez AF, Kitt MM, Lorenz TJ. The design and rationale for the Acute Medically Ill Venous Thromboembolism Prevention with Extended Duration Betrixaban (APEX) study. Am Heart J. 2014 Mar;167(3):335-41. doi: 10.1016/j.ahj.2013.11.006. Epub 2013 Dec 10.

Reference Type DERIVED
PMID: 24576517 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11-019

Identifier Type: -

Identifier Source: org_study_id

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