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Dabigatran Etexilate for Stroke Prevention in Patients With Atrial Fibrillation and Mild to Moderate Renal Impairment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01721837
First received: November 2, 2012
Last updated: June 30, 2014
Last verified: June 2014

November 2, 2012
June 30, 2014
October 2012
June 2013   (final data collection date for primary outcome measure)
Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician) [ Time Frame: One single observation time point: at the time of prescription before the first intake of dabigatran etexilate ] [ Designated as safety issue: No ]
The creatinine clearance was recalculated with the Cockcroft-Gault formula using age, gender, body weight, and serum creatinine.
creatinine clearance (calculated by Cockcroft Gault-Formula) [ Time Frame: day 1 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01721837 on ClinicalTrials.gov Archive Site
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Dabigatran Etexilate for Stroke Prevention in Patients With Atrial Fibrillation and Mild to Moderate Renal Impairment
Use of Pradaxa® (Dabigatran Etexilate) for Stroke Prevention in Patients With Nonvalvular Atrial Fibrillation and Mild to Moderate Renal Impairment

Non-interventional, observational study of physicians' use of Dabigatran etexilate for stroke prevention in patients with atrial fibrillation and mild to moderate renal impairment

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients

Atrial Fibrillation
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Atrial fibrillation and mild to moderate renal impairment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4340
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  • patients with atrial fibrillation foreseen for Pradaxa anticoagulation according to physician's decision for stroke prevention
  • patients with mild or moderate renal impairment
  • age >= 18 years at enrollment

Exclusion criteria:

- severe renal impairment (Creatinine Clearance < 30 ml/min)

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01721837
1160.170
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Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP