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Sequential Expansion of Comparative Effectiveness of Anticoagulants

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ClinicalTrials.gov Identifier: NCT02081807
Recruitment Status : Completed
First Posted : March 7, 2014
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
This cohort study is the sequential expansion of the comparative effectiveness study of oral anticoagulants and plans to identify initiators of oral anticoagulants using electronic claims data from a commercial insurance database to quantify associations between anticoagulant choice (warfarin and dabigatran) and the occurrence of selected outcomes in patients with non-valvular atrial fibrillation at risk for stroke.

Condition or disease
Atrial Fibrillation

Study Type : Observational
Actual Enrollment : 221228 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Sequential Expansion of Comparative Effectiveness of Oral Anticoagulants: A Cohort Study
Actual Study Start Date : March 7, 2014
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Dabigatran
Warfarin



Primary Outcome Measures :
  1. Stroke [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ]
  2. Major bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ]

Secondary Outcome Measures :
  1. Stroke or systemic embolism [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ]
  2. Systemic embolism [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ]
  3. Ischemic stroke [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ]
  4. Hemorrhagic stroke [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ]
  5. Stroke uncertain classification [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ]
  6. Major intracranial bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ]
  7. Major extracranial bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ]
  8. Major gastrointestinal bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ]
  9. Transient Ischemic Attack [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ]
  10. Myocardial infarction [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ]
  11. Venous Thromboembolism [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ]
  12. Deep vein thrombosis [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ]
  13. Pulmonary Embolism [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ]
  14. Major upper gastrointestinal bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ]
  15. Major lower gastrointestinal bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ]
  16. Major urogenital bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ]
  17. Other major bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients 18 years of age and older with non-valvular AF initiating oral anticoagulation therapy
Criteria

Inclusion criteria:

  • A recorded diagnosis of atrial fibrillation.
  • Initiation of anticoagulant medication (dabigatran (or other new oral anticoagulants as they become available) or warfarin).
  • At least 18 years of age on the date of anticoagulant initiation.
  • CHA2DS2-VASc score at least 1

Exclusion criteria:

  • Patients with missing or ambiguous age or sex information.
  • Patients with evidence of valvular disease.
  • Patients with less than 12 months enrolment preceding the date of anticoagulant initiation
  • Patients with a dispensing of any oral anticoagulant during the 12 months preceding the date of anticoagulant initiation
  • Patients with a nursing home stay during the 12 months preceding the date of anticoagulant initiation

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): NCT02081807


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02081807     History of Changes
Other Study ID Numbers: 1160.207
First Posted: March 7, 2014    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017

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