Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness (ADOPT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00457002
First received: April 4, 2007
Last updated: May 14, 2014
Last verified: May 2014
Results First Received: April 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Venous Thrombosis
Pulmonary Embolism
Interventions: Drug: Apixaban
Drug: Enoxaparin

  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 patient, first visit was June 2007 and last patient, last visit was May 2011. Acutely ill patients who had been hospitalized and had an expected hospitalization of an additional 3 or more days after randomization were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
6758 enrolled; 6528 randomized to treatment. Reasons for non-randomization: 2 Adverse event (AE); 34 withdrew consent; 1 death; 3 poor/non-compliance; 162 no longer met study criteria; 2 administrative reason by Sponsor; 26 other reasons.

Reporting Groups
  Description
Apixaban 2.5 mg Oral Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
Enoxaparin 40 mg Subcutaneous Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.

Participant Flow:   Overall Study
    Apixaban 2.5 mg Oral     Enoxaparin 40 mg Subcutaneous  
STARTED     3255     3273  
COMPLETED     2442     2516  
NOT COMPLETED     813     757  
Death                 40                 47  
Adverse Event                 284                 260  
Withdrawal by Subject                 299                 271  
Lost to Follow-up                 72                 71  
Poor/Non-compliance                 46                 33  
No longer met criteria                 41                 37  
Administrative reason by Sponsor                 1                 0  
non-specified                 29                 38  
treated for 1 day; missing status/reason                 1                 0  



  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.
Randomized Participants

Reporting Groups
  Description
Apixaban 2.5 mg Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
Enoxaparin 40 mg Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
Total Total of all reporting groups

Baseline Measures
    Apixaban 2.5 mg     Enoxaparin 40 mg     Total  
Number of Participants  
[units: participants]
  3255     3273     6528  
Age  
[units: years]
Median ( Full Range )
  68.0  
  ( 40 to 101 )  
  67.0  
  ( 40 to 98 )  
  67.0  
  ( 40 to 101 )  
Age, Customized  
[units: participants]
     
Less than (<) 65 years     1401     1411     2812  
Greater than, equal to (>=) 65 and < 75 years     890     884     1774  
>= 75 years     964     978     1942  
Gender  
[units: participants]
     
Female     1629     1696     3325  
Male     1626     1577     3203  
Region of Enrollment [1]
[units: participants]
     
United States     625     620     1245  
Philippines     22     22     44  
Hong Kong     26     26     52  
Taiwan     8     7     15  
Spain     51     50     101  
Ukraine     270     276     546  
Chile     65     65     130  
Israel     168     168     336  
Russian Federation     632     632     1264  
Colombia     10     14     24  
Italy     35     34     69  
India     198     202     400  
France     203     200     403  
Malaysia     9     11     20  
Denmark     49     54     103  
Australia     51     49     100  
Peru     119     121     240  
South Africa     52     48     100  
Netherlands     1     0     1  
Korea, Republic of     33     33     66  
Turkey     9     10     19  
Austria     5     7     12  
United Kingdom     195     194     389  
Hungary     18     16     34  
Czech Republic     53     56     109  
Mexico     58     59     117  
Canada     45     47     92  
Argentina     78     77     155  
Brazil     41     45     86  
Belgium     21     22     43  
Poland     57     60     117  
Singapore     8     12     20  
Norway     3     2     5  
Germany     35     32     67  
Sweden     2     2     4  
Participants with Risk Factors [2]
[units: participants]
     
Previous Venous Thromboembolism (VTE)     141     124     265  
Estrogenic Hormone Therapy     49     27     76  
History of Malignancy     312     320     632  
Chronic Heart Failure     1531     1537     3068  
[1] Randomized Participants.
[2] This baseline measures randomized participants.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population   [ Time Frame: Intended Treatment Period ]

2.  Primary:   Incidence of Major Bleeding During the Treatment Period in Treated Participants   [ Time Frame: Day 1, first dose of study drug, to last dose of study drug plus 2 days ]

3.  Primary:   Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants   [ Time Frame: Day 1, first dose of study drug, to last dose of study drug plus 2 days ]

4.  Primary:   Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants   [ Time Frame: Day 1, first dose of study drug, to last dose of study drug plus 2 days ]

5.  Primary:   Incidence of All Bleeding During the Treatment Period in Treated Participants   [ Time Frame: Day 1, first dose of drug to last dose of drug plus 2 days ]

6.  Secondary:   Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants   [ Time Frame: Day 1 to last dose of parenteral study drug plus 1 day ]

7.  Secondary:   Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants   [ Time Frame: Day 1 to last dose of parenteral study drug plus 1 day ]

8.  Secondary:   Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period   [ Time Frame: Intended Treatment Period ]

9.  Secondary:   Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period   [ Time Frame: Intended Treatment Period ]

10.  Secondary:   Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period   [ Time Frame: Intended Treatment Period ]

11.  Secondary:   Incidence of Adjudicated VTE-Related Death With Onset During the Intended Treatment Period in Randomized Participants   [ Time Frame: Intended Treatment Period ]

12.  Secondary:   Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period   [ Time Frame: Intended Treatment Period ]

13.  Secondary:   Symptomatic Adjudicated VTE or VTE-Related Death With Onset During the Intended Treatment Period   [ Time Frame: Intended Treatment Period ]

14.  Secondary:   Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period   [ Time Frame: Intended Treatment Period ]

15.  Secondary:   Incidence of Adjudicated PE With Onset During the Intended Treatment Period   [ Time Frame: Intended Treatment Period ]

16.  Secondary:   Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period   [ Time Frame: Intended Treatment Period ]

17.  Secondary:   Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period   [ Time Frame: Intended Treatment Period ]

18.  Secondary:   Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period   [ Time Frame: Intended Treatment Period ]

19.  Secondary:   Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period   [ Time Frame: Intended Treatment Period ]

20.  Secondary:   Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period   [ Time Frame: Intended Treatment Period ]

21.  Secondary:   Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period   [ Time Frame: Intended Treatment Period ]

22.  Secondary:   Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants   [ Time Frame: Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths) ]

23.  Secondary:   Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period   [ Time Frame: Day 1 to last dose of study drug plus 2 days ]

24.  Secondary:   Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period   [ Time Frame: Day 1 to last dose of study drug plus 2 days ]

25.  Secondary:   Mean Change From Baseline in Heart Rate in Treated Participants   [ Time Frame: Day 1 to last dose of study drug plus 2 days ]

26.  Secondary:   Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants   [ Time Frame: Day 1 to last dose of study drug plus 2 days ]

27.  Secondary:   Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants   [ Time Frame: Day 1 to last dose of study drug plus 2 days ]

28.  Secondary:   Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants   [ Time Frame: Day 1 to last dose of study drug plus 2 days ]

29.  Secondary:   Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants   [ Time Frame: Day 1 to last dose of study drug plus 2 days ]

30.  Secondary:   Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants   [ Time Frame: Day 1 to last dose of study drug plus 2 days ]

31.  Secondary:   Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements   [ Time Frame: Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs) ]

32.  Secondary:   Number of Participants With Liver-Related Elevations During the Treatment Period in Treated Participants   [ Time Frame: Day 1 to last dose of study drug plus 2 days ]


  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


No publications provided by Bristol-Myers Squibb

Publications automatically indexed to this study:

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00457002     History of Changes
Other Study ID Numbers: CV185-036
Study First Received: April 4, 2007
Results First Received: April 14, 2014
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration