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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00643201




Registration number
NCT00643201
Ethics application status
Date submitted
20/03/2008
Date registered
26/03/2008
Date last updated
21/04/2014

Titles & IDs
Public title
Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism
Scientific title
A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism
Secondary ID [1] 0 0
EUDRACT: 2007-007867-25
Secondary ID [2] 0 0
CV185-056
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis 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 - Enoxaparin
Treatment: Drugs - warfarin
Treatment: Drugs - Placebo for apixaban
Treatment: Drugs - Placebo for enoxaparin
Treatment: Drugs - Placebo for warfarin
Treatment: Drugs - apixaban

Active comparator: Apixaban - apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.

Experimental: Enoxaparin + Warfarin - Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until international normalized ratio (INR) =2.


Treatment: Drugs: Enoxaparin
solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) =2.

Treatment: Drugs: warfarin
tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months

Treatment: Drugs: Placebo for apixaban
tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months

Treatment: Drugs: Placebo for enoxaparin
solution, subcutaneous, 1 mg/kg Q12h until sham INR =2.

Treatment: Drugs: Placebo for warfarin
tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months

Treatment: Drugs: apixaban
tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment
Timepoint [1] 0 0
Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early)
Secondary outcome [1] 0 0
Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death
Timepoint [1] 0 0
Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [2] 0 0
Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death
Timepoint [2] 0 0
Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [3] 0 0
Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding
Timepoint [3] 0 0
Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [4] 0 0
Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding
Timepoint [4] 0 0
Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [5] 0 0
Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period
Timepoint [5] 0 0
Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [6] 0 0
Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period
Timepoint [6] 0 0
Day 1 to Week 24 + + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [7] 0 0
Incidence of Adjudicated Venous Thromboembolism (VTE)-Related Death During the Intended Treatment Period
Timepoint [7] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [8] 0 0
Incidence of Cardiovascular (CV)-Related Death Including VTE-related Death During the Intended Treatment Period
Timepoint [8] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [9] 0 0
Incidence of All-Cause Death During the Intended Treatment Period
Timepoint [9] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [10] 0 0
Incidence of Adjudicated Major Bleeding During the Treatment Period in Treated Participants
Timepoint [10] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [11] 0 0
Incidence of Adjudicated Major/CRNM Bleeding During the Treatment Period in Treated Participants
Timepoint [11] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [12] 0 0
Incidence of Adjudicated Clinically Relevant Non Major (CRNM) Bleeding During the Treatment Period in Treated Participants
Timepoint [12] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [13] 0 0
Incidence of Adjudicated Minor Bleeding During the Treatment Period in Treated Participants
Timepoint [13] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [14] 0 0
Incidence of Adjudicated Total Bleeding During the Treatment Period in Treated Participants
Timepoint [14] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [15] 0 0
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Discontinuations Due to AEs and Death During the Treatment Period in Treated Participants
Timepoint [15] 0 0
First dose to last dose of 24 Weeks + 2 days (AEs) or + 30 days (SAEs) or until drug discontinued
Secondary outcome [16] 0 0
Number of Treated Participants With Marked Abnormalities in Hematology Laboratory Tests
Timepoint [16] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [17] 0 0
Number of Treated Participants With Marked Abnormalities in Electrolyte Laboratory Tests
Timepoint [17] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [18] 0 0
Number of Treated Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests
Timepoint [18] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [19] 0 0
Number of Treated Participants With Marked Abnormalities in Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests
Timepoint [19] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
Secondary outcome [20] 0 0
Number of Treated Participants With Marked Abnormalities in Urinalysis Laboratory Tests
Timepoint [20] 0 0
Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Eligibility
Key inclusion criteria
* Men and women = 18 years of age
* Clinical diagnosis of DVT or PE
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Contraindications for enoxaparin or warfarin
* Active bleeding or high risk for serious bleeding
* Short life expectancy
* Uncontrolled high blood pressure
* Significantly impaired kidney or liver function

Study design
Purpose of the study
Treatment
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
1/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
5614
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Garran
Recruitment hospital [2] 0 0
Local Institution - Concord
Recruitment hospital [3] 0 0
Local Institution - Kogarah
Recruitment hospital [4] 0 0
Local Institution - Lismore
Recruitment hospital [5] 0 0
Local Institution - Randwick
Recruitment hospital [6] 0 0
Local Institution - Herston
Recruitment hospital [7] 0 0
Local Institution - Adelaide
Recruitment hospital [8] 0 0
Local Institution - Bedford Park
Recruitment hospital [9] 0 0
Local Institution - Hobart
Recruitment hospital [10] 0 0
Local Institution - Box Hill
Recruitment hospital [11] 0 0
Local Institution - Clayton
Recruitment hospital [12] 0 0
Local Institution - Ringwood East
Recruitment hospital [13] 0 0
Local Institution - Windsor
Recruitment hospital [14] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2480 - Lismore
Recruitment postcode(s) [5] 0 0
2031 - Randwick
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
5042 - Bedford Park
Recruitment postcode(s) [9] 0 0
7000 - Hobart
Recruitment postcode(s) [10] 0 0
3128 - Box Hill
Recruitment postcode(s) [11] 0 0
3168 - Clayton
Recruitment postcode(s) [12] 0 0
3135 - Ringwood East
Recruitment postcode(s) [13] 0 0
3181 - Windsor
Recruitment postcode(s) [14] 0 0
6001 - Perth
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
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
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
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Maine
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
Mississippi
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Montana
Country [19] 0 0
United States of America
State/province [19] 0 0
Nebraska
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
North Dakota
Country [24] 0 0
United States of America
State/province [24] 0 0
Ohio
Country [25] 0 0
United States of America
State/province [25] 0 0
Oregon
Country [26] 0 0
United States of America
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Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
South Carolina
Country [28] 0 0
United States of America
State/province [28] 0 0
Tennessee
Country [29] 0 0
United States of America
State/province [29] 0 0
Texas
Country [30] 0 0
United States of America
State/province [30] 0 0
Utah
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
Argentina
State/province [32] 0 0
Buenos Aires
Country [33] 0 0
Argentina
State/province [33] 0 0
Santa Fe
Country [34] 0 0
Argentina
State/province [34] 0 0
Cordoba
Country [35] 0 0
Argentina
State/province [35] 0 0
Corrientes
Country [36] 0 0
Austria
State/province [36] 0 0
Graz
Country [37] 0 0
Austria
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Innsbruck
Country [38] 0 0
Austria
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Vienna
Country [39] 0 0
Austria
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Wien
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Minas Gerais
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Brazil
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Parana
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Brazil
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Rio De Janeiro
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Brazil
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Rio Grande Do Sul
Country [44] 0 0
Brazil
State/province [44] 0 0
Sao Paulo
Country [45] 0 0
Brazil
State/province [45] 0 0
SP
Country [46] 0 0
Canada
State/province [46] 0 0
Alberta
Country [47] 0 0
Canada
State/province [47] 0 0
British Columbia
Country [48] 0 0
Canada
State/province [48] 0 0
Manitoba
Country [49] 0 0
Canada
State/province [49] 0 0
New Brunswick
Country [50] 0 0
Canada
State/province [50] 0 0
Ontario
Country [51] 0 0
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State/province [51] 0 0
Quebec
Country [52] 0 0
Chile
State/province [52] 0 0
Magallanes Antartica
Country [53] 0 0
Chile
State/province [53] 0 0
Metropolitana
Country [54] 0 0
Chile
State/province [54] 0 0
Valparaiso
Country [55] 0 0
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Beijing
Country [56] 0 0
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Country [57] 0 0
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Hubei
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Liaoning
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State/province [60] 0 0
Zhejiang
Country [61] 0 0
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State/province [61] 0 0
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Hradec Kralove
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Czech Republic
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Kladno
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Czech Republic
State/province [64] 0 0
Litomysl
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State/province [65] 0 0
Mestec Kralove
Country [66] 0 0
Czech Republic
State/province [66] 0 0
Ostrava Vitkovice
Country [67] 0 0
Czech Republic
State/province [67] 0 0
Ostrava
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Czech Republic
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Praha 10
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Czech Republic
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Praha 1
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Praha 2
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Czech Republic
State/province [71] 0 0
Usti Nad Labem
Country [72] 0 0
Czech Republic
State/province [72] 0 0
Usti Nad Orlici
Country [73] 0 0
Denmark
State/province [73] 0 0
Arhus C
Country [74] 0 0
Denmark
State/province [74] 0 0
Hellerup
Country [75] 0 0
Denmark
State/province [75] 0 0
Herning
Country [76] 0 0
Denmark
State/province [76] 0 0
Hilleroed
Country [77] 0 0
Denmark
State/province [77] 0 0
Horsens
Country [78] 0 0
Denmark
State/province [78] 0 0
Naestved
Country [79] 0 0
Denmark
State/province [79] 0 0
Silkeborg
Country [80] 0 0
France
State/province [80] 0 0
Angers
Country [81] 0 0
France
State/province [81] 0 0
Arras
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France
State/province [82] 0 0
Besancon
Country [83] 0 0
France
State/province [83] 0 0
Clamart
Country [84] 0 0
France
State/province [84] 0 0
Clermont-Ferrand Cedex 01
Country [85] 0 0
France
State/province [85] 0 0
Dijon
Country [86] 0 0
France
State/province [86] 0 0
Grenoble Cedex 9
Country [87] 0 0
France
State/province [87] 0 0
Langres Cedex
Country [88] 0 0
France
State/province [88] 0 0
Le Kremlin-Bicetre
Country [89] 0 0
France
State/province [89] 0 0
Lille Cedex
Country [90] 0 0
France
State/province [90] 0 0
Limoges Cedex
Country [91] 0 0
France
State/province [91] 0 0
Nantes
Country [92] 0 0
France
State/province [92] 0 0
Paris
Country [93] 0 0
France
State/province [93] 0 0
Pierre Benite
Country [94] 0 0
France
State/province [94] 0 0
Saint-Priest En Jarez
Country [95] 0 0
France
State/province [95] 0 0
Toulouse cedex 9
Country [96] 0 0
France
State/province [96] 0 0
Vernon
Country [97] 0 0
Germany
State/province [97] 0 0
Berlin
Country [98] 0 0
Germany
State/province [98] 0 0
Bochum
Country [99] 0 0
Germany
State/province [99] 0 0
Cologne
Country [100] 0 0
Germany
State/province [100] 0 0
Dortmund
Country [101] 0 0
Germany
State/province [101] 0 0
Dresden
Country [102] 0 0
Germany
State/province [102] 0 0
Frankfurt
Country [103] 0 0
Germany
State/province [103] 0 0
Gottingen
Country [104] 0 0
Germany
State/province [104] 0 0
Karlsbad
Country [105] 0 0
Germany
State/province [105] 0 0
Ludwigshafen
Country [106] 0 0
Germany
State/province [106] 0 0
Mannheim
Country [107] 0 0
Germany
State/province [107] 0 0
Munchen
Country [108] 0 0
Germany
State/province [108] 0 0
Munich
Country [109] 0 0
Hong Kong
State/province [109] 0 0
Pokfulman
Country [110] 0 0
Hong Kong
State/province [110] 0 0
Shatin, N.T
Country [111] 0 0
Hungary
State/province [111] 0 0
Budapest
Country [112] 0 0
Hungary
State/province [112] 0 0
Gyula
Country [113] 0 0
Hungary
State/province [113] 0 0
Kecskemet
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Hungary
State/province [114] 0 0
Miskolc
Country [115] 0 0
Hungary
State/province [115] 0 0
Mosonmagyarovar
Country [116] 0 0
Hungary
State/province [116] 0 0
Szekesfehervar
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Hungary
State/province [117] 0 0
Zalaegerszeg
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India
State/province [118] 0 0
Andhra Pradesh
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India
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Gujarat
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India
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Haryana
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India
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Karnataka
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India
State/province [122] 0 0
Maharashtra
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India
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Punjab
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India
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Tagore Nagar
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India
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Tamil Nadu
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India
State/province [126] 0 0
Bangalore
Country [127] 0 0
India
State/province [127] 0 0
Pune
Country [128] 0 0
Israel
State/province [128] 0 0
Lower Galillee
Country [129] 0 0
Israel
State/province [129] 0 0
Afula
Country [130] 0 0
Israel
State/province [130] 0 0
Ashkelon
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Israel
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Israel
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Israel
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Holon
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Israel
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Israel
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Israel
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Israel
State/province [137] 0 0
Petach-Tikva
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Israel
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Rehovot
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Israel
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Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Italy
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Bologna
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Italy
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Castelfranco Veneto (Tv)
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Chieti Scalo
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Italy
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Cosenza
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Milano
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Padova
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Rozzano (Mi)
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Italy
State/province [155] 0 0
San Daniele Del Friuli (Ud)
Country [156] 0 0
Italy
State/province [156] 0 0
Vicenza
Country [157] 0 0
Italy
State/province [157] 0 0
Vittorio Veneto (Tv)
Country [158] 0 0
Korea, Republic of
State/province [158] 0 0
Busan
Country [159] 0 0
Korea, Republic of
State/province [159] 0 0
Seoul
Country [160] 0 0
Malaysia
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Penang
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Malaysia
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Perak
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Malaysia
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Melaka
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Baja California
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Mexico
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Jalisco
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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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Aguascalientes
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Mexico
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Durango
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Alesund
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Norway
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Fredrikstad
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Norway
State/province [173] 0 0
Gjettum
Country [174] 0 0
Norway
State/province [174] 0 0
Gjovik
Country [175] 0 0
Norway
State/province [175] 0 0
Hamar
Country [176] 0 0
Norway
State/province [176] 0 0
Oslo
Country [177] 0 0
Norway
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West Lothian

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)
Trial website
https://clinicaltrials.gov/study/NCT00643201
Trial related presentations / publications
Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.
Cohen AT, Pan S, Byon W, Ilyas BS, Taylor T, Lee TC. Efficacy, Safety, and Exposure of Apixaban in Patients with High Body Weight or Obesity and Venous Thromboembolism: Insights from AMPLIFY. Adv Ther. 2021 Jun;38(6):3003-3018. doi: 10.1007/s12325-021-01716-8. Epub 2021 Apr 22. Erratum In: Adv Ther. 2021 Aug;38(8):4596-4597. doi: 10.1007/s12325-021-01822-7.
Cohen AT, Agnelli G, Buller HR, Gallus A, Raskob GE, Sanders P, Thompson J, Weitz JI. Characteristics and Outcomes in Patients with Venous Thromboembolism Taking Concomitant Anti-Platelet Agents and Anticoagulants in the AMPLIFY Trial. Thromb Haemost. 2019 Mar;119(3):461-466. doi: 10.1055/s-0038-1676983. Epub 2019 Jan 16.
Liu X, Johnson M, Mardekian J, Phatak H, Thompson J, Cohen AT. Apixaban Reduces Hospitalizations in Patients With Venous Thromboembolism: An Analysis of the Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy (AMPLIFY) Trial. J Am Heart Assoc. 2015 Dec 1;4(12):e002340. doi: 10.1161/JAHA.115.002340.
Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Masiukiewicz U, Pak R, Thompson J, Raskob GE, Weitz JI; AMPLIFY Investigators. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013 Aug 29;369(9):799-808. doi: 10.1056/NEJMoa1302507. Epub 2013 Jul 1.
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/NCT00643201