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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00457002




Registration number
NCT00457002
Ethics application status
Date submitted
4/04/2007
Date registered
5/04/2007
Date last updated
8/12/2015

Titles & IDs
Public title
Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness
Scientific title
A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.
Secondary ID [1] 0 0
CV185-036
Universal Trial Number (UTN)
Trial acronym
ADOPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis 0 0
Pulmonary Embolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Apixaban
Treatment: Drugs - Enoxaparin

Experimental: Arm 1 - While hospitalized, Apixaban plus Placebo

Apixaban (Tablets, Oral, 2.5 mg), Placebo (Syringes, SC)

After hospital discharge, Apixaban

Apixaban (Tablets, Oral, 2.5 mg)

Active comparator: Arm 2 - While hospitalized, Enoxaparin plus Placebo

Enoxaparin (Syringes, SC, 40 mg), Placebo (Tablets, Oral)

After hospital discharge: Placebo

Placebo (Tablets, Oral)


Treatment: Drugs: Apixaban
Apixaban: Twice daily, 30 days

Placebo: Once daily, 6-14 days

Treatment: Drugs: Enoxaparin
Enoxaparin: Once daily, 6-14 days

Placebo: Twice daily, 30 days

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population
Timepoint [1] 0 0
Intended Treatment Period
Primary outcome [2] 0 0
Incidence of Major Bleeding During the Treatment Period in Treated Participants
Timepoint [2] 0 0
Day 1, first dose of study drug, to last dose of study drug plus 2 days
Primary outcome [3] 0 0
Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants
Timepoint [3] 0 0
Day 1, first dose of study drug, to last dose of study drug plus 2 days
Primary outcome [4] 0 0
Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants
Timepoint [4] 0 0
Day 1, first dose of study drug, to last dose of study drug plus 2 days
Primary outcome [5] 0 0
Incidence of All Bleeding During the Treatment Period in Treated Participants
Timepoint [5] 0 0
Day 1, first dose of drug to last dose of drug plus 2 days
Secondary outcome [1] 0 0
Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants
Timepoint [1] 0 0
Day 1 to last dose of parenteral study drug plus 1 day
Secondary outcome [2] 0 0
Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants
Timepoint [2] 0 0
Day 1 to last dose of parenteral study drug plus 1 day
Secondary outcome [3] 0 0
Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period
Timepoint [3] 0 0
Intended Treatment Period
Secondary outcome [4] 0 0
Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period
Timepoint [4] 0 0
Intended Treatment Period
Secondary outcome [5] 0 0
Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period
Timepoint [5] 0 0
Intended Treatment Period
Secondary outcome [6] 0 0
Incidence of Adjudicated VTE-Related Death With Onset During the Intended Treatment Period in Randomized Participants
Timepoint [6] 0 0
Intended Treatment Period
Secondary outcome [7] 0 0
Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period
Timepoint [7] 0 0
Intended Treatment Period
Secondary outcome [8] 0 0
Symptomatic Adjudicated VTE or VTE-Related Death With Onset During the Intended Treatment Period
Timepoint [8] 0 0
Intended Treatment Period
Secondary outcome [9] 0 0
Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period
Timepoint [9] 0 0
Intended Treatment Period
Secondary outcome [10] 0 0
Incidence of Adjudicated PE With Onset During the Intended Treatment Period
Timepoint [10] 0 0
Intended Treatment Period
Secondary outcome [11] 0 0
Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period
Timepoint [11] 0 0
Intended Treatment Period
Secondary outcome [12] 0 0
Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period
Timepoint [12] 0 0
Intended Treatment Period
Secondary outcome [13] 0 0
Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period
Timepoint [13] 0 0
Intended Treatment Period
Secondary outcome [14] 0 0
Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period
Timepoint [14] 0 0
Intended Treatment Period
Secondary outcome [15] 0 0
Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period
Timepoint [15] 0 0
Intended Treatment Period
Secondary outcome [16] 0 0
Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period
Timepoint [16] 0 0
Intended Treatment Period
Secondary outcome [17] 0 0
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants
Timepoint [17] 0 0
Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths)
Secondary outcome [18] 0 0
Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period
Timepoint [18] 0 0
Day 1 to last dose of study drug plus 2 days
Secondary outcome [19] 0 0
Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period
Timepoint [19] 0 0
Day 1 to last dose of study drug plus 2 days
Secondary outcome [20] 0 0
Mean Change From Baseline in Heart Rate in Treated Participants
Timepoint [20] 0 0
Day 1 to last dose of study drug plus 2 days
Secondary outcome [21] 0 0
Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants
Timepoint [21] 0 0
Day 1 to last dose of study drug plus 2 days
Secondary outcome [22] 0 0
Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants
Timepoint [22] 0 0
Day 1 to last dose of study drug plus 2 days
Secondary outcome [23] 0 0
Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants
Timepoint [23] 0 0
Day 1 to last dose of study drug plus 2 days
Secondary outcome [24] 0 0
Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants
Timepoint [24] 0 0
Day 1 to last dose of study drug plus 2 days
Secondary outcome [25] 0 0
Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants
Timepoint [25] 0 0
Day 1 to last dose of study drug plus 2 days
Secondary outcome [26] 0 0
Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements
Timepoint [26] 0 0
Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs)
Secondary outcome [27] 0 0
Number of Participants With Liver-Related Elevations During the Treatment Period in Treated Participants
Timepoint [27] 0 0
Day 1 to last dose of study drug plus 2 days

Eligibility
Key inclusion criteria
* men and non-pregnant, non-breastfeeding women
* 40 years or older
* hospitalized with congestive heart failure or acute respiratory failure
* infection (without septic shock)
* acute rheumatic disorder
* inflammatory bowel disease
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* patients with venous thromboembolism (VTE)
* active bleeding or at high risk of bleeding
* unable to take oral medication
* with diseases requiring ongoing treatment with anticoagulants or antiplatelets other than aspirin at a dose = 165 mg/day.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Concord
Recruitment hospital [2] 0 0
Local Institution - St Leonards
Recruitment hospital [3] 0 0
Local Institution - Kippa Ring
Recruitment hospital [4] 0 0
Local Institution - Woolloongabba
Recruitment hospital [5] 0 0
Local Institution - Bedford Park
Recruitment hospital [6] 0 0
Local Institution - Woodville
Recruitment hospital [7] 0 0
Local Institution - Box Hill
Recruitment hospital [8] 0 0
Local Institution - Parkville
Recruitment hospital [9] 0 0
Local Institution - Ringwood East
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
5011 - Woodville
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment postcode(s) [9] 0 0
3135 - Ringwood East
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
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Montana
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United States of America
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Nebraska
Country [19] 0 0
United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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Virginia
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Argentina
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Tucuman
Country [31] 0 0
Argentina
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Cordoba
Country [32] 0 0
Argentina
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Corrientes
Country [33] 0 0
Austria
State/province [33] 0 0
Graz
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Austria
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Wien
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Belgium
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Waals-Brabant
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Belgium
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Antwerpen
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Belgium
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Brasschaat
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Huy
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Leuven
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Minas Gerais
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Brazil
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Parana
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Rio Grande Do Sul
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Brazil
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Sao Paulo
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Ontario
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Chile
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Chile
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Valparaiso
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Colombia
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Bogota
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Colombia
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Jindrichuv Hradec
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Praha 5
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Aalborg
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Denmark
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Aarhus N
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Denmark
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Arhus C
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Denmark
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Frederiksberg
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Denmark
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Glostrup
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Denmark
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Hellerup
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Denmark
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Herlev
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Denmark
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Herning
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Denmark
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Hvidovre
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Denmark
State/province [71] 0 0
Odense
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Denmark
State/province [72] 0 0
Randers No
Country [73] 0 0
Denmark
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Silkeborg
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France
State/province [74] 0 0
Bordeaux
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France
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Brest Cedex
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France
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Brest
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France
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Dijon Cedex
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France
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Grenoble Cedex 9
Country [79] 0 0
France
State/province [79] 0 0
Lille Cedex
Country [80] 0 0
France
State/province [80] 0 0
Nancy
Country [81] 0 0
France
State/province [81] 0 0
Nimes Cedex 9
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France
State/province [82] 0 0
Paris Cedex 10
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France
State/province [83] 0 0
Paris Cedex 15
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France
State/province [84] 0 0
Saint Etienne Cedex 02
Country [85] 0 0
France
State/province [85] 0 0
Vernon
Country [86] 0 0
Germany
State/province [86] 0 0
Bonn
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Germany
State/province [87] 0 0
Coburg
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Germany
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Darmstadt
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Germany
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Dresden
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Germany
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Hannover
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Germany
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Karlsbad
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Germany
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Luebeck
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Germany
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Mannheim
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Germany
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Offenbach
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Germany
State/province [95] 0 0
Witten
Country [96] 0 0
Hong Kong
State/province [96] 0 0
Shatin, N.T.
Country [97] 0 0
Hungary
State/province [97] 0 0
Budapest
Country [98] 0 0
Hungary
State/province [98] 0 0
Debrecen
Country [99] 0 0
Hungary
State/province [99] 0 0
Dunaujvaros
Country [100] 0 0
Hungary
State/province [100] 0 0
Eger
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India
State/province [101] 0 0
Andhra-Pradesh
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India
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Andra Pradesh
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India
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Gujarat
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India
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Karnataka
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India
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Madhya Pardesh
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India
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Maharashtra
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India
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Maharastra
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India
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Punjab
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India
State/province [109] 0 0
Tamil Nadu
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India
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Tamil-Nadu
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India
State/province [111] 0 0
Uttar Pradesh
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India
State/province [112] 0 0
Ahmedabad
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India
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Bangalore
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India
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Hyderabad
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India
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Mumbai
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India
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New Delhi
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Israel
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Afula
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Israel
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Ashkelon
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
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Petach Tikva
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Israel
State/province [122] 0 0
Safed
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Israel
State/province [123] 0 0
Tel Hashomer
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Israel
State/province [124] 0 0
Tel-Aviv
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Israel
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Zerifin
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Italy
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Chieti Scalo
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Italy
State/province [127] 0 0
Cremona
Country [128] 0 0
Italy
State/province [128] 0 0
Padua
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Italy
State/province [129] 0 0
Piacenza
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Italy
State/province [130] 0 0
Reggio Emilia
Country [131] 0 0
Italy
State/province [131] 0 0
Treviso
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Italy
State/province [132] 0 0
Vicenza
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Korea, Republic of
State/province [133] 0 0
Gyeonggi-Do
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Korea, Republic of
State/province [134] 0 0
Seoul
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Korea, Republic of
State/province [135] 0 0
Suwon
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Malaysia
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Kelantan
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Malaysia
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Selangor
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Malaysia
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Mexico
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Distrito Federal
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Mexico
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Nuevo Leon
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Mexico
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Veracruz
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Mexico
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Yucatan
Country [143] 0 0
Mexico
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Queretaro
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Mexico
State/province [144] 0 0
San Luis Potosi
Country [145] 0 0
Netherlands
State/province [145] 0 0
Den Helder
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Norway
State/province [146] 0 0
Kongsvinger
Country [147] 0 0
Peru
State/province [147] 0 0
Lima
Country [148] 0 0
Peru
State/province [148] 0 0
Arequipa
Country [149] 0 0
Peru
State/province [149] 0 0
Callao
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Philippines
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Misamis Oriental
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Philippines
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Las Pinas
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Philippines
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Quezon City
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Poland
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Bydgoszcz
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Poland
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Krakow
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Poland
State/province [155] 0 0
Lodz
Country [156] 0 0
Poland
State/province [156] 0 0
Nowa Sol
Country [157] 0 0
Poland
State/province [157] 0 0
Poznan
Country [158] 0 0
Poland
State/province [158] 0 0
Skierniewice
Country [159] 0 0
Poland
State/province [159] 0 0
Warszawa
Country [160] 0 0
Poland
State/province [160] 0 0
Wejherowo
Country [161] 0 0
Poland
State/province [161] 0 0
Zielona Gora
Country [162] 0 0
Russian Federation
State/province [162] 0 0
Moscow
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Russian Federation
State/province [163] 0 0
Odintsovo
Country [164] 0 0
Russian Federation
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Podolsk
Country [165] 0 0
Russian Federation
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Ryazan
Country [166] 0 0
Russian Federation
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Saint Petersburg
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Russian Federation
State/province [167] 0 0
Saint-Petersburg
Country [168] 0 0
Russian Federation
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Saratov
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Russian Federation
State/province [169] 0 0
St Petersburg
Country [170] 0 0
Russian Federation
State/province [170] 0 0
St. Petersburg
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Russian Federation
State/province [171] 0 0
St.Petersburg
Country [172] 0 0
Singapore
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Singapore
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South Africa
State/province [173] 0 0
Free State
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South Africa
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Yorkshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis \[DVT\]) and lung (pulmonary embolism \[PE\]) that sometimes occur within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.
Trial website
https://clinicaltrials.gov/study/NCT00457002
Trial related presentations / publications
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.
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.
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.
Goldhaber SZ, Leizorovicz A, Kakkar AK, Haas SK, Merli G, Knabb RM, Weitz JI; ADOPT Trial Investigators. Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. N Engl J Med. 2011 Dec 8;365(23):2167-77. doi: 10.1056/NEJMoa1110899. Epub 2011 Nov 13.
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00457002