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RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial

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ClinicalTrials.gov Identifier: NCT00808067
Recruitment Status : Completed
First Posted : December 15, 2008
Results First Posted : April 8, 2014
Last Update Posted : June 9, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition: Atrial Fibrillation
Interventions: Drug: dabigatran dose 1
Drug: dabigatran dose 2

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 5897 subjects were enrolled (rolled over from RE-LY trial), and 5891 were entered in this study. There were 8 subjects not treated; therefore 5883 subjects comprise the 'started' treatment group.

Reporting Groups
  Description
Dabigatran 110 mg Dabigatran etexilate 110 mg twice daily
Dabigatran 150 mg Dabigatran etexilate 150 mg twice daily

Participant Flow:   Overall Study
    Dabigatran 110 mg   Dabigatran 150 mg
STARTED   2927 [1]   2956 [1] 
COMPLETED   2446   2438 
NOT COMPLETED   481   518 
Major/minor bleed                30                44 
Outcome event - other                33                25 
Adverse Event                111                121 
Hospitalization (not including surgery)                18                17 
Hospitalization due to surgery                37                40 
Reduced creatinine clearance                53                55 
Elevated LFT results                7                3 
Patient refused to take study medication                65                76 
Missing                1                0 
Death                1                1 
Procedure                6                7 
Withdrawal by Subject                21                25 
Site closed                4                3 
Physician Decision                47                38 
Protocol Violation                3                11 
Patient elected                7                9 
Site closed for cause                19                19 
Other reason not defined above                5                5 
Excluded from analysis                13                19 
[1] Number of patients which are treated.



  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.
SAF - Safety set; included all treated subjects, but excluded subjects from sites 1059 and 0246.

Reporting Groups
  Description
Dabigatran 110 mg Dabigatran etexilate 110 mg twice daily
Dabigatran 150 mg Dabigatran etexilate 150 mg twice daily
Total Total of all reporting groups

Baseline Measures
   Dabigatran 110 mg   Dabigatran 150 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 2914   2937   5851 
Age 
[Units: Years]
Mean (Standard Deviation) 		 73.1  (8.4)   73.1  (8.4)   73.1  (8.4) 
Gender 
[Units: Participants]
 		     
Female   1000   1026   2026 
Male   1914   1911   3825 


  Outcome Measures

1.  Primary:   Major Bleeding, Annualized Rate of Subjects With Major Bleeds   [ Time Frame: up to 43 months ]
  Show Outcome Measure 1

2.  Secondary:   Stroke, Annualized Rate of Subjects With Stroke   [ Time Frame: up to 43 months ]
  Show Outcome Measure 2

3.  Secondary:   Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE   [ Time Frame: up to 43 months ]
  Show Outcome Measure 3

4.  Secondary:   Pulmonary Embolism (PE), Annualized Rate of Subjects With PE   [ Time Frame: up to 43 months ]
  Show Outcome Measure 4

5.  Secondary:   Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI   [ Time Frame: up to 43 months ]
  Show Outcome Measure 5

6.  Secondary:   Deep Vein Thrombosis, Annualized Rate of Subjects With DVT   [ Time Frame: up to 43 months ]
  Show Outcome Measure 6

7.  Secondary:   Death, Annualized Rate of Subject Death   [ Time Frame: up to 43 months ]
  Show Outcome Measure 7

8.  Secondary:   Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE)   [ Time Frame: up to 43 months ]
  Show Outcome Measure 8

9.  Secondary:   Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death   [ Time Frame: up to 43 months ]
  Show Outcome Measure 9

10.  Secondary:   Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death   [ Time Frame: up to 43 months ]
  Show Outcome Measure 10

11.  Secondary:   Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed   [ Time Frame: up to 43 months ]
  Show Outcome Measure 11

12.  Secondary:   Annualized Rate of Subjects With Minor Bleeds   [ Time Frame: up to 43 months ]
  Show Outcome Measure 12

13.  Secondary:   Annualized Rate of Subjects With Any Bleeds (Major Plus Minor)   [ Time Frame: up to 43 months ]
  Show Outcome Measure 13

14.  Secondary:   Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH)   [ Time Frame: up to 43 months ]
  Show Outcome Measure 14


  Serious Adverse Events


  Other Adverse Events


  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
Non-serious adverse events were not collected on subjects in this study.


  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


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


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00808067     History of Changes
Other Study ID Numbers: 1160.71
2008-005248-17 ( EudraCT Number: EudraCT )
First Submitted: December 12, 2008
First Posted: December 15, 2008
Results First Submitted: December 20, 2013
Results First Posted: April 8, 2014
Last Update Posted: June 9, 2014