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Trial record 1 of 1 for:    re-verse-ad
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Reversal of Dabigatran Anticoagulant Effect With Idarucizumab

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02104947
First Posted: April 7, 2014
Last Update Posted: October 3, 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: July 21, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hemorrhage
Intervention: Drug: idarucizumab

  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
Idarucizumab (Group A) Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
Idarucizumab (Group B) Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.

Participant Flow:   Overall Study
    Idarucizumab (Group A)   Idarucizumab (Group B)
STARTED   301   202 
COMPLETED   222   146 
NOT COMPLETED   79   56 
Withdrawal by Subject                10                3 
Lost to Follow-up                4                4 
Protocol Violation                6                8 
Adverse Event                57                38 
Other than stated above                2                3 



  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: Treated Set is defined as all patients who were administered idarucizumab.

Reporting Groups
  Description
Idarucizumab (Group A) Patients who were treated with dabigatran and who had uncontrolled or life threatening bleeding that required urgent medical or surgical intervention were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
Idarucizumab (Group B) Patients who were treated with dabigatran and who may not have been bleeding, but required an emergency surgery or other invasive procedure for a condition other than bleeding where therapeutic anticoagulation might have increased the risk of intra- and post-operative bleeding were administered idarucizumab 5 g (two 2.5 g vials) as an intravenous (IV) infusion. A single vial contains 2.5 g of idarucizumab. Patients received a 2.5 g vial of study medication and a second 2.5-g vial within the next 15 minutes.
Total Total of all reporting groups

Baseline Measures
   Idarucizumab (Group A)   Idarucizumab (Group B)   Total 
Overall Participants Analyzed 
[Units: Participants]
 301   202   503 
Age 
[Units: Years]
Mean (Standard Deviation)
 77.1  (10.4)   75.9  (10.5)   76.6  (10.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      129  42.9%      100  49.5%      229  45.5% 
Male      172  57.1%      102  50.5%      274  54.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT   [ Time Frame: from the end of the first infusion up to 4 hours after the last infusion on Day 1 ]

2.  Secondary:   Reversal of aPTT and TT From Central Laboratory   [ Time Frame: from the end of the first infusion up to 4 hours after the last infusion on Day 1 ]

3.  Secondary:   Duration of Reversal   [ Time Frame: from the first infusion up to 24 hours after the last infusion on Day 1 ]

4.  Secondary:   Occurrence of Major/Life-threatening/Fatal Bleeding (for Group B Only) Intraoperatively   [ Time Frame: within 24 hours of surgery ]

5.  Secondary:   Time to Cessation of Bleeding (for Group A Only)   [ Time Frame: from the first infusion up to 24 hours after the last infusion on Day 1 ]

6.  Secondary:   Cmin,1 of Unbound Sum (Free) Dabigatran   [ Time Frame: Since the end of first vial of idarucizumab up to 4 hours after the completion of second vial ]

7.  Secondary:   Reversal of Anticoagulation as Measured by Diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) After the First Vial of Idarucizumab and Before the Start of Second Vial   [ Time Frame: after the first vial of idarucizumab and before the start of second vial on Day1 ]


  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
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  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


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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02104947     History of Changes
Other Study ID Numbers: 1321.3
2013-004813-41 ( EudraCT Number: EudraCT )
First Submitted: April 2, 2014
First Posted: April 7, 2014
Results First Submitted: July 21, 2017
Results First Posted: August 18, 2017
Last Update Posted: October 3, 2017