Sequential Expansion of Comparative Effectiveness of Anticoagulants

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02081807
First received: March 6, 2014
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Sequential Expansion of Comparative Effectiveness of Oral Anticoagulants: A Cohort Study

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Stroke [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Major bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Stroke or systemic embolism [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Systemic embolism [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Ischemic stroke [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Hemorrhagic stroke [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Stroke uncertain classification [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Major intracranial bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: Yes ]
  • Major extracranial bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: Yes ]
  • Major gastrointestinal bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: Yes ]
  • Transient Ischemic Attack [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Myocardial infarction [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Venous Thromboembolism [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Deep vein thrombosis [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Pulmonary Embolism [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: No ]
  • Major upper gastrointestinal bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: Yes ]
  • Major lower gastrointestinal bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: Yes ]
  • Major urogenital bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: Yes ]
  • Other major bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 62 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120000
Study Start Date: March 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Dabigatran
Warfarin

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02081807

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

Locations
United States, Massachusetts
1160.207.1 Boehringer Ingelheim Investigational Site Recruiting
Boston, Massachusetts, United States
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02081807     History of Changes
Other Study ID Numbers: 1160.207
Study First Received: March 6, 2014
Last Updated: July 9, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014