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Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00847301
First received: February 18, 2009
Last updated: August 25, 2015
Last verified: August 2015
Results First Received: June 30, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Arthroplasty, Replacement
Thromboembolism

  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
There were 472 patients entered into the study, 428 were treated with moderate renal impairment. Treated patients with moderate renal impairment are presented.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Overall Study Design All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily

Participant Flow:   Overall Study
    Overall Study Design
STARTED   428 
COMPLETED   374 
NOT COMPLETED   54 
Adverse Event                35 
Switch to other anticoagulants                16 
Lost to Follow-up                1 
No prescription after hospital discharge                1 
Other reason not defined above                1 



  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.
The Treated set with moderate renal impairment: this patient set included all patients with CrCl (Creatinine clearance) 30 - 50 mL/min who received at least one 1 of dabigatran etexilate.

Reporting Groups
  Description
All Patients All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.

Baseline Measures
   All Patients 
Overall Participants Analyzed 
[Units: Participants]
 428 
Age 
[Units: Years]
Mean (Standard Deviation)
 78.6  (7.4) 
Gender 
[Units: Participants]
 
Female   324 
Male   104 


  Outcome Measures
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1.  Primary:   Percentage of Patients With Major Bleeding Events (MBE)   [ Time Frame: From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa ]

2.  Primary:   Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality   [ Time Frame: From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa ]

3.  Secondary:   Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality   [ Time Frame: From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa ]

4.  Secondary:   Percentage of Patients With Major Extra-surgical Site Bleedings   [ Time Frame: From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa ]

5.  Secondary:   Volume of Wound Drainage (Post-operative)   [ Time Frame: From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa ]


  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



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00847301     History of Changes
Other Study ID Numbers: 1160.84
Study First Received: February 18, 2009
Results First Received: June 30, 2015
Last Updated: August 25, 2015
Health Authority: Austria: Medicines and Medical Devices Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency