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

Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00152971
First received: September 8, 2005
Last updated: April 22, 2014
Last verified: April 2014
Results First Received: November 18, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Prevention
Conditions: Arthroplasty, Replacement, Knee
Thromboembolism
Interventions: Drug: Dabigatran Dose 1 - day 2 to completion
Drug: Dabigatran Dose 1 - day 1
Drug: Dabigatran Dose 2 - day 2 to completion
Drug: Dabigatran Dose 2 - day 1
Drug: Enoxaparin

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The treatment period is from first administration of study medication, until 3 days after last administration of study medication. Treatment duration is planned for 12 - 15 days. The study period is from first administration of study medication until day 84 - 91.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Whilst 2615 patients were enrolled/randomised to treatment post surgery in this trial, only 2596 started treatment. Therefore, 19 patients were randomised but not treated (treatment was planned to start post surgery).

Reporting Groups
  Description
Dabigatran 220mg qd (once daily) oral
Dabigatran 150mg qd (once daily) oral
Enoxaparin 30mg bid (twice daily) subcutaneous

Participant Flow for 2 periods

Period 1:   Overall Study
    Dabigatran 220mg   Dabigatran 150mg   Enoxaparin
STARTED   857   871   868 
COMPLETED   806 [1]   823 [1]   819 [1] 
NOT COMPLETED   51   48   49 
Adverse Event                12                10                9 
Protocol Violation                10                11                8 
Lost to Follow-up                17                14                13 
Withdrawal by Subject                9                8                14 
not specified                3                5                5 
[1] Non-completers in 'overall study' table may have completed treatment but not study, and vice versa

Period 2:   Treatment
    Dabigatran 220mg   Dabigatran 150mg   Enoxaparin
STARTED   857   871   868 
COMPLETED   786 [1]   808 [1]   788 [1] 
NOT COMPLETED   71   63   80 
Adverse Event                49                40                54 
Protocol Violation                8                6                10 
Lost to Follow-up                1                2                1 
Withdrawal by Subject                4                4                5 
not specified                9                11                10 
[1] Non-completers in 'treatment' table may have completed study but not treatment, and vice versa



  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.
No text entered.

Reporting Groups
  Description
Dabigatran 220mg qd (once daily) oral
Dabigatran 150mg qd (once daily) oral
Enoxaparin 30mg bid (twice daily) subcutaneous
Total Total of all reporting groups

Baseline Measures
   Dabigatran 220mg   Dabigatran 150mg   Enoxaparin   Total 
Overall Participants Analyzed 
[Units: Participants]
 857   871   868   2596 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.2  (9.5)   65.9  (9.5)   66.3  (9.6)   66.1  (9.5) 
Gender 
[Units: Participants]
       
Female   486   507   504   1497 
Male   371   364   364   1099 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 31.6  (6.0)   31.4  (6.1)   31.4  (6.0)   31.5  (6.1) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period   [ Time Frame: First administration until 12-15 days ]

2.  Secondary:   Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period   [ Time Frame: First administration until 12-15 days ]

3.  Secondary:   Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period   [ Time Frame: First administration until 12-15 days ]

4.  Secondary:   Number of Participants With Total Deep Vein Thrombosis During Treatment Period   [ Time Frame: First administration until 12-15 days ]

5.  Secondary:   Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period   [ Time Frame: First administration until 12-15 days ]

6.  Secondary:   Number of Participants With Pulmonary Embolism During Treatment Period   [ Time Frame: First administration until 12-15 days ]

7.  Secondary:   Number of Participants Who Died During Treatment Period   [ Time Frame: First administration until 12-15 days ]

8.  Secondary:   Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period   [ Time Frame: 3 months ]

9.  Secondary:   Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period   [ Time Frame: First administration until 12-15 days ]


  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: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com



Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00152971     History of Changes
Other Study ID Numbers: 1160.24
Study First Received: September 8, 2005
Results First Received: November 18, 2010
Last Updated: April 22, 2014
Health Authority: Canada:
Great Britain:
Mexico:
United States: Food and Drug Administration