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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00371683




Registration number
NCT00371683
Ethics application status
Date submitted
30/08/2006
Date registered
4/09/2006
Date last updated
30/12/2015

Titles & IDs
Public title
Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
Scientific title
A Phase 3 Randomized, Double-Blind Active-Controlled (Enoxaparin), Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery
Secondary ID [1] 0 0
CV185-034
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deep Vein 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 - Enoxaparin + Placebo
Treatment: Drugs - Apixaban + Placebo

Active comparator: A1 - + placebo

Experimental: A2 - + placebo


Treatment: Drugs: Enoxaparin + Placebo
Syringes + tablets, Subcutaneous + Oral, 30mg, twice daily, 12 day treatment period

Treatment: Drugs: Apixaban + Placebo
Tablet + Syringes, Oral + subcutaneous, 2.5 mg, twice daily, 12 day treatment period
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects
Timepoint [1] 0 0
From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Primary outcome [2] 0 0
Event Rate for Participants With Major Bleeding, Clinically Relevant Non-Major Bleeding, Major or Clinically Relevant Non-Major Bleeding, Any Bleeding With Onset During the Treatment Period - Treated Population
Timepoint [2] 0 0
First dose of study drug to last dose, plus 2 days post last dose
Primary outcome [3] 0 0
Event Rate for Participants With Major Bleeding, Clinically Relevant (CR) Non-Major (N-M) Bleeding , Major or Clinically Relevant (CR) Non-Major (N-M) Bleeding, Any Bleeding With Onset During the Follow-Up Period
Timepoint [3] 0 0
Last dose of study drug to Day 72 (60 days)
Secondary outcome [1] 0 0
Event Rate of Composite of Adjudicated Proximal DVT, Non-Fatal PE and All-Cause Death With Onset During the Intended Treatment Period PE and All-cause Death During the Intended Treatment Period
Timepoint [1] 0 0
From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Secondary outcome [2] 0 0
Event Rate of Adjudicated VTE / VTE-related Death With Onset During the Treatment Period
Timepoint [2] 0 0
From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Secondary outcome [3] 0 0
Event Rate for Participants With Proximal DVT/Non-Fatal PE/ VTE-Related Death With Onset During the Intended Treatment Period
Timepoint [3] 0 0
From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Secondary outcome [4] 0 0
Event Rate for Total Participants With Adjudicated VTE/All-Cause Death With Onset During the Intended Treatment Period
Timepoint [4] 0 0
From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Secondary outcome [5] 0 0
Event Rate for Total Participants With VTE/ VTE-Related Death With Onset During the Intended Treatment Period
Timepoint [5] 0 0
From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Secondary outcome [6] 0 0
Event Rate for Participants With All-Cause Death During the Intended Treatment Period
Timepoint [6] 0 0
From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Secondary outcome [7] 0 0
Event Rate for Participants With VTE-Related Death With Onset During the Intended Treatment Period
Timepoint [7] 0 0
From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Secondary outcome [8] 0 0
Event Rate for Participants With Symptomatic VTE/ All-Cause Death With Onset During the Intended Treatment Period
Timepoint [8] 0 0
From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Secondary outcome [9] 0 0
Event Rate for Participants With Symptomatic VTE/ VTE-Related Death With Onset During the Intended Treatment Period
Timepoint [9] 0 0
From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Secondary outcome [10] 0 0
Event Rate for Participants With VTE/Major Bleeding/All-Cause Death With Onset During the Intended Treatment Period
Timepoint [10] 0 0
From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Secondary outcome [11] 0 0
Event Rate for Participants With PE (Fatal or Non-Fatal), DVT (All, Symptomatic Proximal, and Distal, Asymptomatic) With Onset During the Intended Treatment Period
Timepoint [11] 0 0
From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Secondary outcome [12] 0 0
Event Rate for Participants With Proximal DVT, Distal DVT, Asymptomatic Proximal DVT, Asymptomatic Distal DVT With Onset During the Intended Treatment Period
Timepoint [12] 0 0
From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
Secondary outcome [13] 0 0
Event Rate for Participants With Adjudicated Myocardial Infarction (MI) Acute Ischemic Stroke and Thromboembolic Events With Onset During the Treatment Period
Timepoint [13] 0 0
From first dose to last dose, plus 2 days (12 days, plus 2)
Secondary outcome [14] 0 0
Event Rate of Adjudicated MI, Stroke, and Thrombocytopenia Events During the Follow-Up Period
Timepoint [14] 0 0
Post last dose of study drug to Day 72 (60 days)
Secondary outcome [15] 0 0
Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), AEs Leading to Discontinuation, and Deaths - Treated Population
Timepoint [15] 0 0
First dose to last dose, plus 2 days for AEs (12 + 2 days) or plus 30 days for SAEs (12 + 30 days)
Secondary outcome [16] 0 0
Mean Change From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
Timepoint [16] 0 0
Baseline to last dose of study drug, plus 2 days
Secondary outcome [17] 0 0
Mean Change From Baseline in Heart Rate During the Treatment Period
Timepoint [17] 0 0
Baseline to last dose of study drug, plus 2 days
Secondary outcome [18] 0 0
Number of Participants With Hematology Laboratory Marked Abnormality During the Treatment Period
Timepoint [18] 0 0
First dose to last dose of study drug (12 days), plus 2 days
Secondary outcome [19] 0 0
Number of Participants With Liver and Kidney Function Chemistry Laboratory Marked Abnormalities During the Treatment Period
Timepoint [19] 0 0
First dose to last dose of study drug (12 days), plus 2 days
Secondary outcome [20] 0 0
Number of Participants With Electrolyte Chemistry Laboratory Marked Abnormalities During the Treatment Period
Timepoint [20] 0 0
First dose to last dose of study drug (12 days), plus 2 days
Secondary outcome [21] 0 0
Number of Participants With Other Chemistry Laboratory Marked Abnormalities During the Treatment Period
Timepoint [21] 0 0
First dose to last dose of study drug (12 days), plus 2 days

Eligibility
Key inclusion criteria
Key

* Men and non-pregnant, non-breastfeeding women
* 18 years or older
* Scheduled for knee replacement surgery

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* hereditary or acquired bleeding disorders
* clotting disorders
* bleeding or high risk for bleeding
* drugs that affect bleeding or coagulation
* need for ongoing parenteral or oral anticoagulation

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
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2008
Sample size
Target
Accrual to date
Final
3608
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Garran
Recruitment hospital [2] 0 0
Local Institution - Camperdown
Recruitment hospital [3] 0 0
Local Institution - Caringbah
Recruitment hospital [4] 0 0
Local Institution - Lismore
Recruitment hospital [5] 0 0
Local Institution - Gold Coast
Recruitment hospital [6] 0 0
Local Institution - Adelaide
Recruitment hospital [7] 0 0
Local Institution - Bedford Park
Recruitment hospital [8] 0 0
Local Institution - Box Hill
Recruitment hospital [9] 0 0
Local Institution - Windsor
Recruitment hospital [10] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
NSW 2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2229 - Caringbah
Recruitment postcode(s) [4] 0 0
2480 - Lismore
Recruitment postcode(s) [5] 0 0
4215 - Gold Coast
Recruitment postcode(s) [6] 0 0
5011 - Adelaide
Recruitment postcode(s) [7] 0 0
5042 - Bedford Park
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3181 - Windsor
Recruitment postcode(s) [10] 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
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Cordoba
Country [14] 0 0
Brazil
State/province [14] 0 0
Parana
Country [15] 0 0
Brazil
State/province [15] 0 0
Rio Grande Do Sul
Country [16] 0 0
Brazil
State/province [16] 0 0
Sao Paulo
Country [17] 0 0
Canada
State/province [17] 0 0
Alberta
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Prince Edward Island
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
Denmark
State/province [21] 0 0
Horsholm
Country [22] 0 0
Denmark
State/province [22] 0 0
Kopenhamn S
Country [23] 0 0
Hungary
State/province [23] 0 0
Kecskemet
Country [24] 0 0
Hungary
State/province [24] 0 0
Szekesfehervar
Country [25] 0 0
Hungary
State/province [25] 0 0
Szolnok
Country [26] 0 0
Israel
State/province [26] 0 0
Afula
Country [27] 0 0
Israel
State/province [27] 0 0
Beer-Sheva
Country [28] 0 0
Israel
State/province [28] 0 0
Haifa
Country [29] 0 0
Israel
State/province [29] 0 0
Holon
Country [30] 0 0
Israel
State/province [30] 0 0
Kfar-Saba
Country [31] 0 0
Israel
State/province [31] 0 0
Petach-Tikva
Country [32] 0 0
Israel
State/province [32] 0 0
Rehovot
Country [33] 0 0
Israel
State/province [33] 0 0
Zerifin
Country [34] 0 0
Mexico
State/province [34] 0 0
Baja California
Country [35] 0 0
Mexico
State/province [35] 0 0
Distrito Federal
Country [36] 0 0
Mexico
State/province [36] 0 0
Jalisco
Country [37] 0 0
Mexico
State/province [37] 0 0
Nuevo Leon
Country [38] 0 0
Mexico
State/province [38] 0 0
Tamaulipas
Country [39] 0 0
Mexico
State/province [39] 0 0
Veracruz
Country [40] 0 0
Mexico
State/province [40] 0 0
Yucatan
Country [41] 0 0
Mexico
State/province [41] 0 0
Chihuahua
Country [42] 0 0
Poland
State/province [42] 0 0
Bialystok
Country [43] 0 0
Poland
State/province [43] 0 0
Krakow
Country [44] 0 0
Poland
State/province [44] 0 0
Lodz
Country [45] 0 0
Poland
State/province [45] 0 0
Lublin
Country [46] 0 0
Poland
State/province [46] 0 0
Szczecin
Country [47] 0 0
Poland
State/province [47] 0 0
Warszawa
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Moscow
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Samara
Country [50] 0 0
Russian Federation
State/province [50] 0 0
St. Petersburg
Country [51] 0 0
Sweden
State/province [51] 0 0
Goteborg
Country [52] 0 0
Turkey
State/province [52] 0 0
Adana
Country [53] 0 0
Turkey
State/province [53] 0 0
Bursa
Country [54] 0 0
Turkey
State/province [54] 0 0
Mersin
Country [55] 0 0
Turkey
State/province [55] 0 0
Trabzon

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

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/NCT00371683