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: October 30, 2013
Last verified: October 2013
  Purpose

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


Condition
Atrial Fibrillation

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • creatinine clearance (calculated by Cockcroft Gault-Formula) [ Time Frame: day 1 ] [ Designated as safety issue: No ]

Enrollment: 4398
Study Start Date: October 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
AF and renal impairment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721837

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

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01721837     History of Changes
Other Study ID Numbers: 1160.170
Study First Received: November 2, 2012
Last Updated: October 30, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Atrial Fibrillation
Renal Insufficiency
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 23, 2014