Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Comparative Effectiveness of Oral Anticoagulants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01847547
First received: April 18, 2013
Last updated: June 3, 2014
Last verified: April 2014
Results First Received: April 22, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Atrial Fibrillation

  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
This is an observational study. Patients were not actively recruited in this study. The data source was the UnitedHealth database.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
11882 patients fulfilled the in- and ex-clusion criteria. Only 5982 patients remained after matching on the Propensity Score.

Reporting Groups
  Description
Dabigatran Propensity score matched patients starting treatment with dabigatran
Warfarin Propensity score matched patients starting treatment with warfarin

Participant Flow:   Overall Study
    Dabigatran     Warfarin  
STARTED     2991     2991  
COMPLETED     2991     2991  
NOT COMPLETED     0     0  



  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.
This initial cohort study includes matched treatment groups of 2,991 patients with non-valvular atrial fibrillation who initiated dabigatran and 2,991 patients who initiated warfarin that were drawn from a pool of 11,882 eligible initiators. These first feasibility data are limited by a small sample size.

Reporting Groups
  Description
Dabigatran Propensity score matched patients starting treatment with dabigatran
Warfarin Propensity score matched patients starting treatment with warfarin
Total Total of all reporting groups

Baseline Measures
    Dabigatran     Warfarin     Total  
Number of Participants  
[units: participants]
  2991     2991     5982  
Age  
[units: years]
Mean ± Standard Deviation
  63.86  ± 10.99     63.26  ± 11.04     63.60  ± 11.01  
Gender  
[units: participants]
     
Female     943     877     1820  
Male     2048     2114     4162  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence Rate of Stroke   [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ]

2.  Primary:   Incidence Rate of Major Bleeding   [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ]

3.  Secondary:   Incidence Rate of Myocardial Infarction   [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ]

4.  Secondary:   Incidence Rate of Venous Thromboembolism   [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ]

5.  Secondary:   Incidence Rate of Deep Vein Thrombosis   [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ]

6.  Secondary:   Incidence Rate of Pulmonary Embolism   [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ]

7.  Secondary:   Incidence Rate of Major Lower Gastrointestinal Bleeding   [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ]

8.  Secondary:   Incidence Rate of Major Urogenital Bleeding   [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ]

9.  Secondary:   Incidence Rate of Major Other Bleeding   [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ]

10.  Secondary:   Incidence Rate of Transient Ischemic Attack   [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ]

11.  Secondary:   Incidence Rate of Major Upper Gastrointestinal Bleeding   [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ]

12.  Secondary:   Incidence Rate of Stroke or Systemic Embolism   [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ]

13.  Secondary:   Incidence Rate of Systemic Embolism   [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ]

14.  Secondary:   Incidence Rate of Ischemic Stroke   [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ]

15.  Secondary:   Incidence Rate of Hemorrhagic Stroke   [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ]

16.  Secondary:   Incidence Rate of Stroke Uncertain Classification   [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ]

17.  Secondary:   Incidence Rate of Major Intracranial Bleeding   [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ]

18.  Secondary:   Incidence Rate of Major Extracranial Bleeding   [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ]

19.  Secondary:   Incidence Rate of Major Gastrointestinal Bleeding   [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ]


  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
These first data are limited by small sample size, short follow up, few events resulting in wide confidence intervals. No comparative conclusions are possible. After the feasibility analysis future analysis will increase patient numbers and follow up


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01847547     History of Changes
Other Study ID Numbers: 1160.157
Study First Received: April 18, 2013
Results First Received: April 22, 2014
Last Updated: June 3, 2014
Health Authority: Germany: