Follow on Study From RE-ALIGN

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01505881
First received: January 5, 2012
Last updated: July 10, 2014
Last verified: July 2014
Results First Received: June 6, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Thromboembolism
Heart Valve Prosthesis
Interventions: Drug: dabigatran etexilate low dose
Drug: warfarin 5mg
Drug: dabigatran etexilate intermediate dose
Drug: warfarin 1mg
Drug: dabigatran etexilate high dose
Drug: warfarin 3mg

  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
No text entered.

Reporting Groups
  Description
Dabigatran Etexilate (DE) Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
Warfarin Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator

Participant Flow:   Overall Study
    Dabigatran Etexilate (DE)     Warfarin  
STARTED     99     59  
COMPLETED     95     58  
NOT COMPLETED     4     1  
Adverse Event                 0                 1  
Lost to Follow-up                 2                 0  
Withdrawal by Subject                 2                 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.
Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug

Reporting Groups
  Description
Dabigatran Etexilate (DE) Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
Warfarin Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
Total Total of all reporting groups

Baseline Measures
    Dabigatran Etexilate (DE)     Warfarin     Total  
Number of Participants  
[units: participants]
  99     59     158  
Age  
[units: years]
Mean ± Standard Deviation
  57.8  ± 8.0     56.1  ± 10.1     57.2  ± 8.8  
Gender  
[units: participants]
     
Female     37     19     56  
Male     62     40     102  



  Outcome Measures
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1.  Primary:   Percentage of Patients With Any Adverse Event (AE)   [ Time Frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days) ]

2.  Secondary:   Percentage of Patients With AEs Leading to Discontinuation of Trial Drug   [ Time Frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days) ]

3.  Secondary:   Percentage of Patients With Serious AEs   [ Time Frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days) ]

4.  Secondary:   Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.   [ Time Frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days) ]


  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 study was terminated prematurely due to safety concerns arising during conduct of the trial.


  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: NCT01505881     History of Changes
Other Study ID Numbers: 1160.138, 2011-002285-21
Study First Received: January 5, 2012
Results First Received: June 6, 2014
Last Updated: July 10, 2014
Health Authority: Belgium:
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Central Committee Research Involving Human Subjects
Norway: Norwegian Medicines Agency
Poland: Registration Medicinal Product Medical Device Biocidal Product
United States: Food and Drug Administration