Comparative Effectiveness of Oral Anticoagulants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01847547
First received: April 18, 2013
Last updated: June 3, 2014
Last verified: April 2014
  Purpose

This cohort study 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: Comparative Effectiveness of Oral Anticoagulants: A Cohort Study

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Incidence Rate of Stroke [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  • Incidence Rate of Major Bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: Yes ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.


Secondary Outcome Measures:
  • Incidence Rate of Myocardial Infarction [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  • Incidence Rate of Venous Thromboembolism [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  • Incidence Rate of Deep Vein Thrombosis [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  • Incidence Rate of Pulmonary Embolism [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  • Incidence Rate of Major Lower Gastrointestinal Bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: Yes ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  • Incidence Rate of Major Urogenital Bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: Yes ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  • Incidence Rate of Major Other Bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: Yes ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  • Incidence Rate of Transient Ischemic Attack [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  • Incidence Rate of Major Upper Gastrointestinal Bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: Yes ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.

  • Incidence Rate of Stroke or Systemic Embolism [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  • Incidence Rate of Systemic Embolism [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  • Incidence Rate of Ischemic Stroke [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  • Incidence Rate of Hemorrhagic Stroke [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  • Incidence Rate of Stroke Uncertain Classification [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: No ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9.

  • Incidence Rate of Major Intracranial Bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: Yes ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  • Incidence Rate of Major Extracranial Bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: Yes ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.

  • Incidence Rate of Major Gastrointestinal Bleeding [ Time Frame: From treatment initiation until end of follow-up; up to 20 months ] [ Designated as safety issue: Yes ]
    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.


Enrollment: 5982
Study Start Date: April 2013
Study Completion Date: April 2013
Primary Completion Date: April 2013 (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 (AF).
  • Initiation of anticoagulant medication (dabigatran or warfarin).
  • At least 18 years of age on the date of anticoagulant initiation CHA2DS2-VASc-Score >=1

Exclusion criteria:

  • Patients with missing or ambiguous age or sex information
  • Patients with documented evidence of valvular disease
  • Patients with less than 12 months enrolment in the UnitedHealth Research Database preceding the date of anticoagulant initiation
  • Patients with prior use of any oral anticoagulant
  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: NCT01847547

Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01847547     History of Changes
Other Study ID Numbers: 1160.157
Study First Received: April 18, 2013
Results First Received: April 22, 2014
Last Updated: June 3, 2014
Health Authority: Germany:

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 October 16, 2014