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

This study is currently recruiting participants.
Verified May 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01721837
First received: November 2, 2012
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  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 Dabigatran Etexilate for Stroke Prevention in Patients With Atrial Fibrillation and Mild to Moderate Renal Impairment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

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

Estimated Enrollment: 6000
Study Start Date: October 2012
Estimated Study Completion Date: June 2013
Estimated 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

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Show 1495 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01721837     History of Changes
Other Study ID Numbers: 1160.170
Study First Received: November 2, 2012
Last Updated: May 13, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013