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

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ClinicalTrials.gov Identifier: NCT01721837
Recruitment Status : Completed
First Posted : November 6, 2012
Results First Posted : July 31, 2014
Last Update Posted : July 31, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease
Atrial Fibrillation

Study Type : Observational
Actual Enrollment : 4340 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Pradaxa® (Dabigatran Etexilate) for Stroke Prevention in Patients With Nonvalvular Atrial Fibrillation and Mild to Moderate Renal Impairment
Study Start Date : October 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013


Group/Cohort
Atrial fibrillation and mild to moderate renal impairment



Primary Outcome Measures :
  1. 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 ]
    The creatinine clearance was recalculated with the Cockcroft-Gault formula using age, gender, body weight, and serum creatinine.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721837


  Show 1616 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01721837     History of Changes
Other Study ID Numbers: 1160.170
First Posted: November 6, 2012    Key Record Dates
Results First Posted: July 31, 2014
Last Update Posted: July 31, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Atrial Fibrillation
Renal Insufficiency
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Kidney Diseases
Urologic Diseases
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants