Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery (ADVANCE-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00452530
First received: March 23, 2007
Last updated: July 8, 2014
Last verified: July 2014
Results First Received: April 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Deep Vein Thrombosis
Pulmonary Embolism
Interventions: Drug: Enoxaparin
Drug: Apixaban
Drug: Enoxaparin-matching placebo
Drug: Apixaban-matching placebo

  Participant Flow


  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants randomized to treatment

Reporting Groups
  Description
Apixaban, 2.5 mg BID + Placebo Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
Enoxaparin, 40 mg QD + Placebo Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
Total Total of all reporting groups

Baseline Measures
   Apixaban, 2.5 mg BID + Placebo   Enoxaparin, 40 mg QD + Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 1528   1529   3057 
Age 
[Units: Years]
Median (Standard Deviation)
 67  (9.85)   67  (9.82)   67  (9.84) 
Age, Customized 
[Units: Participants]
     
Younger than 65 years   632   636   1268 
65 years to younger than 75 years   608   576   1184 
75 years and older   288   317   605 
Gender 
[Units: Participants]
     
Female   1089   1127   2216 
Male   439   402   841 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   1216   1211   2427 
Black/African American   14   17   31 
Asian   252   254   506 
Native Hawaiian/Other Pacific Islander   1   1   2 
Other [Not specified]   45   46   91 
Hispanic/Latino   0   1   1 
Not Hispanic/Latino   53   57   110 
Ethnicity not reported   1475   1471   2946 
Region of Enrollment 
[Units: Participants]
     
Philippines   12   14   26 
Spain   61   60   121 
Ukraine   181   182   363 
Russian Federation   150   156   306 
Israel   43   43   86 
Chile   1   5   6 
Colombia   36   35   71 
Italy   69   69   138 
India   92   92   184 
France   72   68   140 
Malaysia   4   4   8 
Denmark   26   23   49 
South Africa   56   56   112 
China   90   90   180 
Korea, Republic of   40   38   78 
Austria   156   151   307 
United Kingdom   63   61   124 
Czech Republic   48   50   98 
Hungary   17   19   36 
Mexico   60   59   119 
Belgium   27   25   52 
Brazil   17   17   34 
Poland   41   45   86 
Singapore   8   9   17 
Norway   35   36   71 
Germany   122   122   244 
Sweden   1   0   1 
Type of Risk Factor 
[Units: Participants]
     
Knee replacement   257   286   543 
Hip replacement   90   80   170 
Hip or knee fracture surgery   55   49   104 
Deep vein thrombosis   36   32   68 
Pulmonary embolism   10   10   20 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of Adjudicated Venous Thromboembolic Event-related and All-cause Deaths With Onset During the Intended-treatment Period   [ Time Frame: Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study drug ]

2.  Secondary:   Rate of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During the Intended Treatment Period   [ Time Frame: Day of randomization to later of 2 days after last dose or 14 days after first dose; 14 days after randomization for those who did not receive study ]

3.  Secondary:   Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), and Major Bleeding or CRNM   [ Time Frame: Days 1 to 12 ]

4.  Secondary:   Number of Participants With Serious Adverse Events (SAE), Bleeding Adverse Events (AEs), Discontinuations Due to AEs, and Death as Outcome   [ Time Frame: Days 1 through 12 + 2 days (nonserious AEs, bleeding AES) or 30 days (SAES, deaths) after last dose of study drug ]

5.  Other Pre-specified:   Summary of Laboratory Marked Abnormalities on Hematology and Liver and Kidney Function Test Results During the Treatment Period (Patients With Available Measurements)   [ Time Frame: Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up ]

6.  Other Pre-specified:   Summary of Laboratory Marked Abnormalities in Electrolyte and Other Clinical Test Results During the Treatment Period (Patients With Available Measurements)   [ Time Frame: Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (±5 days) of follow-up ]

7.  Other Pre-specified:   Summary of Laboratory Marked Abnormalities in Urinalysis Results During the Treatment Period-Treated Subjects With Available Measurements (Urinalysis)   [ Time Frame: Randomization to Days 2, 3, 4, and 12 (±2 days) and at Days 42 and 72 (± 5 days) of follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00452530     History of Changes
Other Study ID Numbers: CV185-047
EUdraCT: 2006-006896-19
Study First Received: March 23, 2007
Results First Received: April 14, 2014
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration