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Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00423319
First received: January 17, 2007
Last updated: April 14, 2014
Last verified: April 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: Prevention
Conditions: Deep Vein Thrombosis
Pulmonary Embolism
Interventions: Drug: Enoxaparin
Drug: Apixaban
Drug: Enoxaparin-matching placebo
Drug: Apixaban-matching placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 5765 subjects were enrolled, and 5407 were randomized to double-blind study drug.

Reporting Groups
  Description
Apixaban, 2.5 mg BID Plus 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 Plus Placebo Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID

Participant Flow:   Overall Study
    Apixaban, 2.5 mg BID Plus Placebo   Enoxaparin, 40 mg QD Plus Placebo
STARTED   2708 [1]   2699 [1] 
Participants Who Received Treatment   2673   2659 
COMPLETED   2484   2447 
NOT COMPLETED   224   252 
Death                2                0 
Adverse Event                93                112 
Withdrawal by Subject                86                99 
Lost to Follow-up                4                3 
Poor compliance or noncompliance                1                1 
No longer meets study criteria                15                15 
Not specified                23                22 
[1] Randomized



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Apixaban, 2.5 mg BID Plus 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 Plus 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 Plus Placebo   Enoxaparin, 40 mg QD Plus Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 2708   2699   5407 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.9  (11.79)   60.6  (11.82)   60.8  (11.81) 
Age, Customized 
[Units: Participants]
     
Younger than 65 years   1608   1605   3213 
65 to younger than 75 years   770   767   1537 
75 years and older   330   327   657 
Gender 
[Units: Participants]
     
Female   1430   1451   2881 
Male   1278   1248   2526 
Region of Enrollment 
[Units: Participants]
     
United States   450   441   891 
Spain   32   29   61 
Ukraine   217   219   436 
Russian Federation   274   276   550 
Israel   57   56   113 
United Kingdom   77   78   155 
India   56   56   112 
France   75   74   149 
Hungary   152   150   302 
Mexico   73   74   147 
Canada   359   356   715 
Argentina   53   54   107 
Belgium   59   60   119 
Poland   184   185   369 
Romania   24   25   49 
Australia   101   99   200 
Denmark   99   99   198 
Germany   135   134   269 
Norway   47   48   95 
China   121   124   245 
Sweden   63   62   125 


  Outcome Measures
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1.  Primary:   Rate of Composite of Adjudicated Venous Thromboembolic Event (VTE)-Related (Pulmonary Embolism and Symptomatic and Asymptomatic Deep Vein Thrombosis[DVT]) and All-cause Death During the Intended Treatment Period   [ Time Frame: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose ]

2.  Secondary:   Rate of Composite of Adjudicated Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism, and Venous Thromboembolic Event-related Death With Onset During Intended Treatment Period   [ Time Frame: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose ]

3.  Secondary:   Rates of Adjudicated All-cause Death, VTE-related Death, Pulmonary Embolism (PE), Nonfatal PE, Deep Vein Thrombosis (DVT) (Symptomatic and Asymptomatic), Symptomatic and Asymptomatic Proximal and Distal DVT During the Intended Treatment Period   [ Time Frame: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose ]

4.  Secondary:   Rate of Major Bleeding, Clinically Relevant Nonmajor Bleeding (CRNM), Major or CRNM, and Any Bleeding During the Treatment Period   [ Time Frame: First dose of study drug (presurgery) through 2 days after the last dose of study drug ]

5.  Secondary:   Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), and Death as Outcome   [ Time Frame: First dose of study drug (presurgery) through 30 days after the last dose of study drug ]

6.  Secondary:   Number of Participants With a Bleeding-related Adverse Event During the Treatment Period   [ Time Frame: First dose of study drug (presurgery) through 2 days after the last dose of study drug ]

7.  Secondary:   Number of Participants With a Bleeding-related Adverse Events During the Treatment Period (Continued)   [ Time Frame: First dose of study drug (presurgery) through 2 days after the last dose of study drug ]

8.  Secondary:   Number of Participants With a Bleeding-related Adverse Event During the Treatment Period (Continued)   [ Time Frame: First dose of study drug (presurgery) through 2 days after the last dose of study drug ]

9.  Secondary:   Number of Participants With Neurologic Adverse Events With Onset During the Treatment Period   [ Time Frame: First dose of study drug (presurgery) through 2 days after the last dose of study drug ]

10.  Secondary:   Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period   [ Time Frame: First dose of study drug (presurgery) through 2 days after the last dose of study drug ]

11.  Secondary:   Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)   [ Time Frame: First dose of study drug (presurgery) through 2 days after the last dose of study drug ]

12.  Secondary:   Number of Participants With Marked Abnormalities (MA) in Clinical Laboratory Test Results During the Treatment Period (Continued)   [ Time Frame: First dose of study drug (presurgery) through 2 days after the last dose of study drug ]

13.  Secondary:   Number of Participants With Adverse Events Related to Elevations in Liver Function Test Results With Onset During the Treatment Period   [ Time Frame: First dose of study drug (presurgery) through 30 days after the last dose of study drug ]

14.  Secondary:   Rates of Adjudicated Myocardial Infarction (MI)/Stroke, MI, Stroke, and Thrombocytopenia During the Intended Treatment Period   [ Time Frame: Day 1 (first dose of study drug) to later of 2 days after last dose or 38 days after first dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: NCT00423319     History of Changes
Other Study ID Numbers: CV185-035
Study First Received: January 17, 2007
Results First Received: April 14, 2014
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration