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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00808067
First received: December 12, 2008
Last updated: June 3, 2014
Last verified: March 2014
History of Changes
Results First Received: December 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Atrial Fibrillation
Interventions: Drug: dabigatran dose 1
Drug: dabigatran dose 2

  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
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
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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.
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  
Number of Participants  
[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
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1.  Primary:   Major Bleeding, Annualized Rate of Subjects With Major Bleeds   [ Time Frame: up to 43 months ]
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2.  Secondary:   Stroke, Annualized Rate of Subjects With Stroke   [ Time Frame: up to 43 months ]
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3.  Secondary:   Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE   [ Time Frame: up to 43 months ]
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4.  Secondary:   Pulmonary Embolism (PE), Annualized Rate of Subjects With PE   [ Time Frame: up to 43 months ]
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5.  Secondary:   Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI   [ Time Frame: up to 43 months ]
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6.  Secondary:   Deep Vein Thrombosis, Annualized Rate of Subjects With DVT   [ Time Frame: up to 43 months ]
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7.  Secondary:   Death, Annualized Rate of Subject Death   [ Time Frame: up to 43 months ]
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8.  Secondary:   Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE)   [ Time Frame: up to 43 months ]
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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 ]
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13.  Secondary:   Annualized Rate of Subjects With Any Bleeds (Major Plus Minor)   [ Time Frame: up to 43 months ]
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14.  Secondary:   Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH)   [ Time Frame: up to 43 months ]
  Show Outcome Measure 14


  Serious Adverse Events
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  Other Adverse Events
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  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
Non-serious adverse events were not collected on subjects in this study.


  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 Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided by Boehringer Ingelheim

Publications automatically indexed to this study:


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00808067     History of Changes
Other Study ID Numbers: 1160.71, 2008-005248-17
Study First Received: December 12, 2008
Results First Received: December 20, 2013
Last Updated: June 3, 2014
Health Authority: Australia: Dept of Health and Ageing Therapeutic Goods Admin
Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia
Canada: Health Canada, Therapeutic Products Directorate
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Denmark: The Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn
Great Britain: MHRA
Greece: National Organization fo Medicines (EOF) National Ethics Committe
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy (OGYI), H-1051 Budapest
India: Drug Control General of India
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ethics Committee
Korea, Republic of: Korea Food and Drug Administration (KFDA)
Malaysia: Drug Control Authority
Netherlands: Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Philippines: Bureau of Food and Drug
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: INFARMED I.P.
Romania: National Medicines Agency, Bucharest
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
Sweden: Medical Products Agency Regional Ethics Committee of Uppsala
Switzerland: Swissmedic
Taiwan: Department of Health, Executive Yuan, Taiwan
Thailand: Thai Food & Drug Administration
United States: Food and Drug Administration