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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: December 7, 2015
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 
Overall Participants Analyzed 
[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 
[1] Randomized Participants.
Participants with Risk Factors [1] 
[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] This baseline measures randomized participants.


  Outcome Measures
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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


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

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: December 7, 2015
Health Authority: United States: Food and Drug Administration