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Post-Marketing Surveillance of Prazaxa® on the Long-term Use in Patients With Nonvalvular Atrial Fibrillation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01491178
First Posted: December 13, 2011
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
To investigate the safety and efficacy of long-term use of Prazaxa® Capsules in patients with nonvalvular atrial fibrillation for preventing the occurrence of ischemic stroke or systemic embolism (SEE).

Condition Intervention
Atrial Fibrillation Drug: Prazaxa

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance on the Long-Term Use of Prazaxa® Capsules in Patients With Nonvalvular Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Incidences of adverse drug reactions [ Time Frame: up to 104 weeks ]

Secondary Outcome Measures:
  • Incidence of systemic embolism [ Time Frame: up to 104 weeks ]
  • Incidence of stroke [ Time Frame: up to 104 weeks ]

Enrollment: 6772
Study Start Date: December 2011
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with NVAF Drug: Prazaxa
Dabigatran etexilate

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
5000
Criteria

Inclusion criteria:

- Patients with nonvalvular atrial fibrillation who have never received Prazaxa Capsules for preventing the occurrence of ischemic stroke and systemic embolism will be included.

Exclusion criteria:

- None

  Contacts and Locations
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): NCT01491178


  Show 487 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01491178     History of Changes
Other Study ID Numbers: 1160.130
First Submitted: December 12, 2011
First Posted: December 13, 2011
Last Update Posted: February 17, 2017
Last Verified: February 2017

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