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Randomized, Open Label Study of Dabigatran Etexilate in Elective Percutaneous Coronary Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00818753
First received: January 7, 2009
Last updated: June 3, 2014
Last verified: December 2013
Results First Received: August 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Heart Catheterization
Interventions: Drug: dabigatran 110 mg
Drug: dabigatran 150 mg
Drug: unfractionated heparin

  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 110mg Bis in Die (BID) No text entered.
Dabigatran 150mg Bis in Die (BID) No text entered.
Heparin Unfractionated heparin administered during intervention

Participant Flow:   Overall Study
    Dabigatran 110mg Bis in Die (BID)     Dabigatran 150mg Bis in Die (BID)     Heparin  
STARTED     22 [1]   21 [1]   10 [1]
COMPLETED     19     21     9  
NOT COMPLETED     3     0     1  
Protocol Violation                 1                 0                 0  
Other reason (not specified)                 0                 0                 1  
Randomised and not treated                 2                 0                 0  
[1] There were 53 participants randomised, but only 51 were 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.
No text entered.

Reporting Groups
  Description
Dabigatran 110mg Bis in Die (BID) No text entered.
Dabigatran 150mg Bis in Die (BID) No text entered.
Heparin Unfractionated heparin administered during intervention
Total Total of all reporting groups

Baseline Measures
    Dabigatran 110mg Bis in Die (BID)     Dabigatran 150mg Bis in Die (BID)     Heparin     Total  
Number of Participants  
[units: participants]
  22     21     10     53  
Age  
[units: Years]
Mean ± Standard Deviation
  65.5  ± 8.7     63.0  ± 8.5     67.0  ± 8.3     64.8  ± 8.5  
Gender  
[units: participants]
       
Female     8     6     3     17  
Male     14     15     7     36  
Race/Ethnicity, Customized [1]
[units: participants]
  22     21     10     53  
Creatinine clearance [2]
[units: mL/min]
Mean ± Standard Deviation
  98.5  ± 38.2     96.3  ± 19.3     95.7  ± 26.5     97.0  ± 28.6  
[1] All participants were white
[2] Baseline creatinine clearance was not available for 3 patients in the Dabigatran 110mg treatment group.



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis   [ Time Frame: From 22 to 165 minutes ]

2.  Secondary:   Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy   [ Time Frame: From 22 to 165 minutes ]

3.  Secondary:   Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow   [ Time Frame: From 22 to 165 minutes ]

4.  Secondary:   Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis   [ Time Frame: From 22 to 165 minutes ]

5.  Secondary:   Number of Participants With Bleeding Events   [ Time Frame: First administration until 7-14 days after PCI (Percutaneous Coronary Intervention) ]


  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
Although a total of 50 patients are included in the FAS, 4 of these patients did not have data for the primary endpoint and are therefore not included in the odd ratio calculation


  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: NCT00818753     History of Changes
Other Study ID Numbers: 1160.73, 2007-007536-25
Study First Received: January 7, 2009
Results First Received: August 5, 2011
Last Updated: June 3, 2014
Health Authority: Netherlands: Central Committee Research Involving Human Subjects