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The Comparative Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-valvular Atrial Fibrillation Population With Humana Healthcare Coverage

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02061748
First Posted: February 13, 2014
Last Update Posted: June 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
Results First Submitted: March 13, 2017  
Study Type: Observational
Study Design: Observational Model: Other;   Time Perspective: Retrospective
Condition: Atrial Fibrillation
Intervention: Drug: Observational

  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
A non-interventional study based on existing data was conducted. This is a retrospective database analysis to assess the safety and effectiveness of dabigatran compared to warfarin in patients diagnosed with non-valvular atrial fibrillation (NVAF) in the real-world setting using the Humana population.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant flow and demographic section is based on Pre-propensity score matching data however to analyze the outcome measures Post-propensity score matching data were used.

Reporting Groups
  Description
Dabigatran Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
Warfarin Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.

Participant Flow:   Overall Study
    Dabigatran   Warfarin
STARTED   7646   30853 
COMPLETED   7646   30853 
NOT COMPLETED   0   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.
Number of selected patients (total) before propensity score matching.

Reporting Groups
  Description
Dabigatran Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
Warfarin Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
Total Total of all reporting groups

Baseline Measures
   Dabigatran   Warfarin   Total 
Overall Participants Analyzed 
[Units: Participants]
 7646   30853   38499 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.2  (8.6)   74.8  (8.2)   74.5  (8.3) 
Sex/Gender, Customized 
[Units: Participants]
     
Female   3316   13944   17260 
Male   4330   16906   21236 
Unknown   0   3   3 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Stroke (Primary Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

2.  Primary:   Stroke (Post-hoc Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

3.  Primary:   Major Bleeding (Primary Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

4.  Primary:   Major Bleeding (Post-hoc Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

5.  Secondary:   Ischemic Stroke (Primary Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

6.  Secondary:   Ischemic Stroke (Post-hoc Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

7.  Secondary:   Hemorrhagic Stroke (Primary Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

8.  Secondary:   Hemorrhagic Stroke (Post-hoc Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

9.  Secondary:   Major Intracranial Bleeding (Primary Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

10.  Secondary:   Major Intracranial Bleeding (Post-hoc Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

11.  Secondary:   Major Extracranial Bleeding (Primary Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

12.  Secondary:   Major Extracranial Bleeding (Post-hoc Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

13.  Secondary:   Major GI Bleeding (Primary Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

14.  Secondary:   Major GI Bleeding (Post-hoc Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

15.  Secondary:   Major Upper GI Bleeding (Primary Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

16.  Secondary:   Major Upper GI Bleeding (Post-hoc Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

17.  Secondary:   Major Lower GI Bleeding (Primary Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

18.  Secondary:   Major Lower GI Bleeding (Post-hoc Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

19.  Secondary:   Major Urogenital Bleeding (Primary Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

20.  Secondary:   Major Urogenital Bleeding (Post-hoc Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

21.  Secondary:   Other Major Bleeds (Primary Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

22.  Secondary:   Other Major Bleeds (Post-hoc Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

23.  Secondary:   Transient Ischemic Attack (TIA) (Primary Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

24.  Secondary:   TIA (Post-hoc Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

25.  Secondary:   Myocardial Infarction (MI) (Primary Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

26.  Secondary:   MI (Post-hoc Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

27.  Secondary:   Venous Thromboembolism (Primary Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

28.  Secondary:   Venous Thromboembolism (Post-hoc Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

29.  Secondary:   Deep Vein Thrombosis (Primary Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

30.  Secondary:   Deep Vein Thrombosis (Post-hoc Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

31.  Secondary:   Pulmonary Embolism (Primary Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

32.  Secondary:   Pulmonary Embolism (Post-hoc Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

33.  Secondary:   All-cause Death (Primary Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months) ]

34.  Secondary:   All-cause Death (Post-hoc Analysis)   [ Time Frame: From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 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
This was retrospective study using the Humana database. Adverse events (other than the primary and secondary endpoints) were not collected per protocol.


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



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02061748     History of Changes
Other Study ID Numbers: 1160.192
First Submitted: February 12, 2014
First Posted: February 13, 2014
Results First Submitted: March 13, 2017
Results First Posted: June 8, 2017
Last Update Posted: June 8, 2017