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Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00633893
First received: March 5, 2008
Last updated: October 30, 2013
Last verified: October 2013
Results First Received: August 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Venous Thrombosis
Interventions: Drug: Apixaban
Drug: 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
First participant, first visit: 16 May 2008; Last participant, last visit: 24 August 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2711 enrolled/2482 randomized: 133 did not meet inclusion, exclusion criteria; 48 withdrew consent; 8 non-compliance; 3 each administrative and clinical reasons; 2 lost to follow up; 1 death; 1 adverse event (AE), 30 other. Data from 4 participants in site 0650 not analyzed/included in randomized population because source for data not confirmed.

Reporting Groups
  Description
Apixaban 2.5 mg Participants received 2.5 mg oral tablet apixaban twice a day (BID)
Apixaban 5 mg Participants received 5 mg oral tablet apixaban BID.
Placebo Participants received matching placebo oral tablet BID.

Participant Flow:   Overall Study
    Apixaban 2.5 mg   Apixaban 5 mg   Placebo
STARTED   840   813 [1]   829 [2] 
COMPLETED   726   684   641 
NOT COMPLETED   114   129   188 
Death                1                3                9 
Adverse Event                65                58                126 
Withdrawal by Subject                7                12                6 
Lost to Follow-up                2                4                8 
Poor/non-compliance                5                12                3 
Pregnancy                2                1                1 
Not meet/no longer meets criteria                4                6                4 
not specified                28                33                31 
[1] 2 participants were randomized to 5 mg study drug but not treated.
[2] 3 participants were randomized to placebo but not treated.



  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.
All randomized participants regardless of whether treatment was actually received were included; intent to treat (ITT) principle.

Reporting Groups
  Description
Apixaban 2.5 mg Participants received 2.5 mg oral tablet apixaban BID.
Apixaban 5 mg Participants received 5 mg oral tablet apixaban BID.
Placebo Participants received matching placebo oral tablet BID.
Total Total of all reporting groups

Baseline Measures
   Apixaban 2.5 mg   Apixaban 5 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 840   813   829   2482 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.6  (15.3)   56.4  (15.6)   57.1  (15.2)   56.7  (15.4) 
Gender 
[Units: Participants]
       
Female   353   344   361   1058 
Male   487   469   468   1424 
Region of Enrollment 
[Units: Participants]
       
Portugal   1   1   0   2 
United States   88   75   96   259 
Philippines   5   3   3   11 
Hong Kong   4   3   4   11 
Spain   27   25   26   78 
Ukraine   87   77   88   252 
Chile   2   1   2   5 
Russian Federation   45   49   46   140 
Israel   34   34   34   102 
Italy   67   65   61   193 
India   24   23   24   71 
France   60   55   50   165 
Australia   30   28   31   89 
Denmark   47   58   42   147 
South Africa   34   42   30   106 
Korea, Republic of   4   3   2   9 
Austria   12   8   11   31 
United Kingdom   33   29   30   92 
Czech Republic   43   49   48   140 
Mexico   22   18   22   62 
Canada   22   17   15   54 
Argentina   7   9   6   22 
Poland   45   44   48   137 
Brazil   19   24   30   73 
Singapore   1   2   3   6 
Romania   6   7   7   20 
Norway   9   9   10   28 
Germany   62   55   60   177 
Index Event Classification [1] 
[Units: Participants]
       
Proximal DVT   544   527   551   1622 
PE   296   286   278   860 
[1] Number of participants with Proximal DVT (defined at the site) and number with PE (defined at the site). In the event a participant had both proximal DVT and PE, the participant was classified to PE.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation   [ Time Frame: Day 1 up to 12 Months ]

2.  Primary:   Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation   [ Time Frame: Day 1 up to 12 months ]

3.  Secondary:   Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or VTE-related Death During the Intended Treatment Period - Randomized Population With Imputation   [ Time Frame: Day 1 up to 12 Months ]

4.  Secondary:   Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) -Related Death During the Intended Treatment Period - Randomized Population With Imputation   [ Time Frame: Day 1 up to 12 Months ]

5.  Secondary:   Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation   [ Time Frame: Day 1 up to 12 Months ]

6.  Secondary:   Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation   [ Time Frame: Day 1 up to 12 Months ]

7.  Secondary:   Adjudicated Venous Thromboembolism (VTE) - Related Death During the Intended Treatment Period - Randomized Population With Imputation   [ Time Frame: Day 1 up to 12 Months ]

8.  Secondary:   Adjudicated Cardiovascular (CV)-Related Death During the Intended Treatment Period - Randomized Population With Imputation   [ Time Frame: Day 1 up to 12 Months ]

9.  Secondary:   Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation   [ Time Frame: Day 1 up to 12 Months ]

10.  Secondary:   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   [ Time Frame: Day 1 up to 12 Months ]

11.  Secondary:   Adjudicated Major Bleeding During the Treatment Period - Treated Population   [ Time Frame: Day 1 up to 12 Months ]

12.  Secondary:   Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants   [ Time Frame: Day 1 up to 12 Months ]

13.  Secondary:   Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants   [ Time Frame: Day 1 up to 12 months ]

14.  Secondary:   Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants   [ Time Frame: Day 1 up to 12 months ]

15.  Secondary:   Adjudicated Total Bleeding During the Treatment Period - Treated Participants   [ Time Frame: Day 1 up to 12 months ]

16.  Secondary:   Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Venous Thromboembolism-related Death During the Intended Treatment Period - Randomized Population Without Imputation   [ Time Frame: Day 1 up to 12 Months ]

17.  Secondary:   Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) - Related Death During the Intended Treatment Period - Randomized Population Without Imputation   [ Time Frame: Day 1 up to 12 Months ]

18.  Secondary:   Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation   [ Time Frame: Day 1 up to 12 Months ]

19.  Secondary:   Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation   [ Time Frame: Day 1 up to 12 Months ]

20.  Secondary:   Adjudicated Venous Thromboembolism (VTE)- Related Death During the Intended Treatment Period - Randomized Population Without Imputation   [ Time Frame: Day 1 up to 12 Months ]

21.  Secondary:   Adjudicated Cardio Vascular (CV)-Related Death During the Intended Treatment Period - Randomized Population Without Imputation   [ Time Frame: Day 1 up to 12 Months ]

22.  Secondary:   Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation   [ Time Frame: Day 1 up to 12 Months ]


  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: NCT00633893     History of Changes
Other Study ID Numbers: CV185-057
EUDRACT: 2007-004953-27
Study First Received: March 5, 2008
Results First Received: August 19, 2013
Last Updated: October 30, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Canada: Health Canada
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Chile: Instituto de Salud Pública de Chile
Mexico: Federal Commission for Sanitary Risks Protection
Austria: Federal Office for Safety in Health Care
Denmark: Danish Medicines Agency
France: Ministry of Health
Germany: Ministry of Health
Israel: Ministry of Health
Italy: Ministry of Health
Norway: Directorate of Health
Spain: Spanish Agency of Medicines
South Africa: Department of Health
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: Ministry of Health
Hungary: Ministry of Health, Social and Family Affairs
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Hong Kong: Department of Health
India: Central Drugs Standard Control Organization
Korea: Food and Drug Administration
Malaysia: National Pharmaceutical Control Bureau
Taiwan: Department of Health
Romania: National Medicines Agency
Portugal: National Pharmacy and Medicines Institute