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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00633893




Registration number
NCT00633893
Ethics application status
Date submitted
5/03/2008
Date registered
12/03/2008
Date last updated
25/11/2013

Titles & IDs
Public title
Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism
Scientific title
A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism
Secondary ID [1] 0 0
EUDRACT: 2007-004953-27
Secondary ID [2] 0 0
CV185-057
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 - Apixaban
Treatment: Drugs - Placebo

Experimental: 1 - 2.5 mg

Experimental: 2 - 5.0 mg

Active comparator: 3 - 0 mg


Treatment: Drugs: Apixaban
Tablets, Oral, twice daily, 12 months

Treatment: Drugs: Placebo
Tablets, Oral, twice daily, 12 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation
Timepoint [1] 0 0
Day 1 up to 12 Months
Primary outcome [2] 0 0
Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation
Timepoint [2] 0 0
Day 1 up to 12 months
Secondary outcome [1] 0 0
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or VTE-related Death During the Intended Treatment Period - Randomized Population With Imputation
Timepoint [1] 0 0
Day 1 up to 12 Months
Secondary outcome [2] 0 0
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) -Related Death During the Intended Treatment Period - Randomized Population With Imputation
Timepoint [2] 0 0
Day 1 up to 12 Months
Secondary outcome [3] 0 0
Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation
Timepoint [3] 0 0
Day 1 up to 12 Months
Secondary outcome [4] 0 0
Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation
Timepoint [4] 0 0
Day 1 up to 12 Months
Secondary outcome [5] 0 0
Adjudicated Venous Thromboembolism (VTE) - Related Death During the Intended Treatment Period - Randomized Population With Imputation
Timepoint [5] 0 0
Day 1 up to 12 Months
Secondary outcome [6] 0 0
Adjudicated Cardiovascular (CV)-Related Death During the Intended Treatment Period - Randomized Population With Imputation
Timepoint [6] 0 0
Day 1 up to 12 Months
Secondary outcome [7] 0 0
Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation
Timepoint [7] 0 0
Day 1 up to 12 Months
Secondary outcome [8] 0 0
Number of Participants With an Adjudicated Symptomatic Nonfatal Venous Thromboembolism (VTE) Recurrence or Death (All Cause) During the Intended Treatment Period - Randomized Participants Without Imputation
Timepoint [8] 0 0
Day 1 up to 12 Months
Secondary outcome [9] 0 0
Adjudicated Major Bleeding During the Treatment Period - Treated Population
Timepoint [9] 0 0
Day 1 up to 12 Months
Secondary outcome [10] 0 0
Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants
Timepoint [10] 0 0
Day 1 up to 12 Months
Secondary outcome [11] 0 0
Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants
Timepoint [11] 0 0
Day 1 up to 12 months
Secondary outcome [12] 0 0
Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants
Timepoint [12] 0 0
Day 1 up to 12 months
Secondary outcome [13] 0 0
Adjudicated Total Bleeding During the Treatment Period - Treated Participants
Timepoint [13] 0 0
Day 1 up to 12 months
Secondary outcome [14] 0 0
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Venous Thromboembolism-related Death During the Intended Treatment Period - Randomized Population Without Imputation
Timepoint [14] 0 0
Day 1 up to 12 Months
Secondary outcome [15] 0 0
Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) - Related Death During the Intended Treatment Period - Randomized Population Without Imputation
Timepoint [15] 0 0
Day 1 up to 12 Months
Secondary outcome [16] 0 0
Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation
Timepoint [16] 0 0
Day 1 up to 12 Months
Secondary outcome [17] 0 0
Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation
Timepoint [17] 0 0
Day 1 up to 12 Months
Secondary outcome [18] 0 0
Adjudicated Venous Thromboembolism (VTE)- Related Death During the Intended Treatment Period - Randomized Population Without Imputation
Timepoint [18] 0 0
Day 1 up to 12 Months
Secondary outcome [19] 0 0
Adjudicated Cardio Vascular (CV)-Related Death During the Intended Treatment Period - Randomized Population Without Imputation
Timepoint [19] 0 0
Day 1 up to 12 Months
Secondary outcome [20] 0 0
Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation
Timepoint [20] 0 0
Day 1 up to 12 Months

Eligibility
Key inclusion criteria
* Men and women = 18 years of age;
* Clinical diagnosis of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE);
* Anticoagulant treatment completed
* No recurrence of Venous Thromboembolism (VTE)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with indications for long-term treatment with a vitamin K antagonist
* Active bleeding or high risk for serious bleeding
* Short life expectancy
* Uncontrolled high blood pressure
* 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
1/05/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2012
Sample size
Target
Accrual to date
Final
2711
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 - Kogarah
Recruitment hospital [3] 0 0
Local Institution - Lismore
Recruitment hospital [4] 0 0
Local Institution - St Leonards
Recruitment hospital [5] 0 0
Local Institution - Herston
Recruitment hospital [6] 0 0
Local Institution - Kippa Ring
Recruitment hospital [7] 0 0
Local Institution - Woolloongabba
Recruitment hospital [8] 0 0
Local Institution - Adelaide
Recruitment hospital [9] 0 0
Local Institution - Bedford Park
Recruitment hospital [10] 0 0
Local Institution - Launceston
Recruitment hospital [11] 0 0
Local Institution - Box Hill
Recruitment hospital [12] 0 0
Local Institution - Clayton
Recruitment hospital [13] 0 0
Local Institution - Footscray
Recruitment hospital [14] 0 0
Local Institution - Parkville
Recruitment hospital [15] 0 0
Local Institution - Richmond
Recruitment hospital [16] 0 0
Local Institution - Ringwood East
Recruitment hospital [17] 0 0
Local Institution - Windsor
Recruitment hospital [18] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2480 - Lismore
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
5042 - Bedford Park
Recruitment postcode(s) [10] 0 0
7250 - Launceston
Recruitment postcode(s) [11] 0 0
3128 - Box Hill
Recruitment postcode(s) [12] 0 0
3168 - Clayton
Recruitment postcode(s) [13] 0 0
3011 - Footscray
Recruitment postcode(s) [14] 0 0
3050 - Parkville
Recruitment postcode(s) [15] 0 0
3121 - Richmond
Recruitment postcode(s) [16] 0 0
3135 - Ringwood East
Recruitment postcode(s) [17] 0 0
3181 - Windsor
Recruitment postcode(s) [18] 0 0
6000 - 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
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
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Delaware
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
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United States of America
State/province [8] 0 0
Georgia
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United States of America
State/province [9] 0 0
Idaho
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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
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United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
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Michigan
Country [17] 0 0
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Missouri
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Montana
Country [19] 0 0
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Nebraska
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
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United States of America
State/province [21] 0 0
North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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Pennsylvania
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Rhode Island
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Tennessee
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Texas
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Utah
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United States of America
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Virginia
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Washington
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Santa Fe
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Argentina
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Corrientes
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Graz
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Innsbruck
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Vienna
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Wien
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Bahia
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Arhus C
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Braedstrup
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Esbjerg
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Hellerup
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Arras
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France
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Besancon
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Brest Cedex
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France
State/province [78] 0 0
Clamart
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France
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Clermont-Ferrand Cedex 01
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France
State/province [80] 0 0
Dijon
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France
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Grenoble
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France
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Le Kremlin-Bicetre
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France
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Lille Cedex
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France
State/province [84] 0 0
Limoges Cedex
Country [85] 0 0
France
State/province [85] 0 0
Lyon Cedex 03
Country [86] 0 0
France
State/province [86] 0 0
Nantes
Country [87] 0 0
France
State/province [87] 0 0
Saint-Priest En Jarez
Country [88] 0 0
France
State/province [88] 0 0
Toulouse Cedex 9
Country [89] 0 0
France
State/province [89] 0 0
Vernon
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Bonn
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Germany
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Cologne
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Germany
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Dortmund
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Germany
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Dresden
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Germany
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Erfurt
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Germany
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Frankfurt
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Germany
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Gottingen
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Germany
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Karlsbad
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Germany
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Krefeld
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Germany
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Ludwigshafen
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Germany
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Mannheim
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Germany
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Munchen
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Germany
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Munich
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State/province [105] 0 0
Hong Kong
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Hong Kong
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Shatin, N.T
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India
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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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India
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Kerala
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India
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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
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Ahmedabad
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India
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Bangalore, Karnataka
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India
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Bangalore
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India
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Israel
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Israel
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Hadera
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Israel
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Haifa
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Israel
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Holon
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Kiryat Hadassah
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Israel
State/province [129] 0 0
Nahariya
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Israel
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Petach-Tikva
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Israel
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Safed
Country [132] 0 0
Israel
State/province [132] 0 0
Tel Aviv
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Israel
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Tel Hashomer
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Bollate
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Italy
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Bologna
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Chieti Scalo
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Cosenza
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Ferrara
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Firenze
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Milano
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Padova
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Palermo
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Pavia
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Piacenza
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Pisa
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Roma
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San Daniele Del Friuli (Ud)
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Udine
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Venezia
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Italy
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Vittorio Veneto (Tv)
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Busan
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Korea, Republic of
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Nuevo Leon
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Sinaloa
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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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Chihuahua
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Mexico
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Durango
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Mexico
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Puebla
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Mexico
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Queretaro
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Mexico
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San Luis Potosi
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Norway
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Alesund
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Norway
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Fredrikstad
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Norway
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Gjettum
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Norway
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Gjovik
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Norway
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Hamar
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Norway
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Oslo
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Philippines
State/province [177] 0 0
Cavite
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Philippines
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Davao City
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Philippines
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Pasig City
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Philippines
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Quezon City
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Poland
State/province [181] 0 0
Arkonska 4
Country [182] 0 0
Poland
State/province [182] 0 0
Bialystok
Country [183] 0 0
Poland
State/province [183] 0 0
Bydgoszcz
Country [184] 0 0
Poland
State/province [184] 0 0
Gdansk
Country [185] 0 0
Poland
State/province [185] 0 0
Gdynia
Country [186] 0 0
Poland
State/province [186] 0 0
Lodz
Country [187] 0 0
Poland
State/province [187] 0 0
Lublin
Country [188] 0 0
Poland
State/province [188] 0 0
Poznan
Country [189] 0 0
Poland
State/province [189] 0 0
Przeworsk
Country [190] 0 0
Poland
State/province [190] 0 0
Szczecin
Country [191] 0 0
Poland
State/province [191] 0 0
Tarnobrzeg
Country [192] 0 0
Poland
State/province [192] 0 0
Warsawa
Country [193] 0 0
Poland
State/province [193] 0 0
Warsaw
Country [194] 0 0
Poland
State/province [194] 0 0
Warszawa
Country [195] 0 0
Poland
State/province [195] 0 0
Wroclaw
Country [196] 0 0
Portugal
State/province [196] 0 0
Guarda
Country [197] 0 0
Portugal
State/province [197] 0 0
Lisboa
Country [198] 0 0
Puerto Rico
State/province [198] 0 0
San Juan
Country [199] 0 0
Romania
State/province [199] 0 0
Baia Mare
Country [200] 0 0
Romania
State/province [200] 0 0
Bucharest
Country [201] 0 0
Romania
State/province [201] 0 0
Targu Mures
Country [202] 0 0
Russian Federation
State/province [202] 0 0
Arkhangelsk
Country [203] 0 0
Russian Federation
State/province [203] 0 0
Kemerovo
Country [204] 0 0
Russian Federation
State/province [204] 0 0
Moscow
Country [205] 0 0
Russian Federation
State/province [205] 0 0
Novosibirsk
Country [206] 0 0
Russian Federation
State/province [206] 0 0
Rostov-On Don
Country [207] 0 0
Russian Federation
State/province [207] 0 0
Ryazan
Country [208] 0 0
Russian Federation
State/province [208] 0 0
Saint Petersburg
Country [209] 0 0
Russian Federation
State/province [209] 0 0
Saint-Petersburg
Country [210] 0 0
Russian Federation
State/province [210] 0 0
Samara
Country [211] 0 0
Russian Federation
State/province [211] 0 0
Saratov
Country [212] 0 0
Russian Federation
State/province [212] 0 0
St Petersburg
Country [213] 0 0
Russian Federation
State/province [213] 0 0
Tomsk
Country [214] 0 0
Russian Federation
State/province [214] 0 0
Yaroslavl
Country [215] 0 0
Singapore
State/province [215] 0 0
Singapore
Country [216] 0 0
South Africa
State/province [216] 0 0
Free State
Country [217] 0 0
South Africa
State/province [217] 0 0
Gauteng
Country [218] 0 0
South Africa
State/province [218] 0 0
Kwa Zulu Natal
Country [219] 0 0
South Africa
State/province [219] 0 0
Western Cape
Country [220] 0 0
Spain
State/province [220] 0 0
Alicante
Country [221] 0 0
Spain
State/province [221] 0 0
Barcelona
Country [222] 0 0
Spain
State/province [222] 0 0
Madrid
Country [223] 0 0
Spain
State/province [223] 0 0
Cadiz
Country [224] 0 0
Spain
State/province [224] 0 0
Getafe
Country [225] 0 0
Spain
State/province [225] 0 0
Girona
Country [226] 0 0
Spain
State/province [226] 0 0
L'Hospitalet De Llobregat
Country [227] 0 0
Spain
State/province [227] 0 0
Leon
Country [228] 0 0
Spain
State/province [228] 0 0
Mourente
Country [229] 0 0
Spain
State/province [229] 0 0
Pamplona
Country [230] 0 0
Spain
State/province [230] 0 0
Salamanca
Country [231] 0 0
Spain
State/province [231] 0 0
Sant Boi De Llobregat
Country [232] 0 0
Spain
State/province [232] 0 0
Tarragona
Country [233] 0 0
Spain
State/province [233] 0 0
Toledo
Country [234] 0 0
Spain
State/province [234] 0 0
Valencia
Country [235] 0 0
Ukraine
State/province [235] 0 0
Chernihiv
Country [236] 0 0
Ukraine
State/province [236] 0 0
Dnipropetrovsk
Country [237] 0 0
Ukraine
State/province [237] 0 0
Donetsk
Country [238] 0 0
Ukraine
State/province [238] 0 0
Ivano-Frankivsk
Country [239] 0 0
Ukraine
State/province [239] 0 0
Kharkiv
Country [240] 0 0
Ukraine
State/province [240] 0 0
Kyiv
Country [241] 0 0
Ukraine
State/province [241] 0 0
Lviv
Country [242] 0 0
Ukraine
State/province [242] 0 0
Odesa
Country [243] 0 0
Ukraine
State/province [243] 0 0
Ternopil
Country [244] 0 0
Ukraine
State/province [244] 0 0
Vinnytsia
Country [245] 0 0
Ukraine
State/province [245] 0 0
Zaporizhzhia
Country [246] 0 0
United Kingdom
State/province [246] 0 0
Aberdeenshire
Country [247] 0 0
United Kingdom
State/province [247] 0 0
Essex
Country [248] 0 0
United Kingdom
State/province [248] 0 0
Greater London
Country [249] 0 0
United Kingdom
State/province [249] 0 0
Greater Manchester
Country [250] 0 0
United Kingdom
State/province [250] 0 0
Humberside
Country [251] 0 0
United Kingdom
State/province [251] 0 0
Nottinghamshire
Country [252] 0 0
United Kingdom
State/province [252] 0 0
Suffolk
Country [253] 0 0
United Kingdom
State/province [253] 0 0
West Midlands

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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00633893