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OpenTrials
Completed

NCT Number: NCT01847547

Comparative Effectiveness of Oral Anticoagulants

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence Rate of Stroke

    Time frame: From treatment initiation until end of follow-up; up to 20 months

    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  2. Incidence Rate of Major Bleeding

    Time frame: From treatment initiation until end of follow-up; up to 20 months

    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.

Secondary outcomes

  1. Incidence Rate of Myocardial Infarction

    Time frame: From treatment initiation until end of follow-up; up to 20 months

    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  2. Incidence Rate of Venous Thromboembolism

    Time frame: From treatment initiation until end of follow-up; up to 20 months

    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  3. Incidence Rate of Deep Vein Thrombosis

    Time frame: From treatment initiation until end of follow-up; up to 20 months

    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  4. Incidence Rate of Pulmonary Embolism

    Time frame: From treatment initiation until end of follow-up; up to 20 months

    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  5. Incidence Rate of Major Lower Gastrointestinal Bleeding

    Time frame: From treatment initiation until end of follow-up; up to 20 months

    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  6. Incidence Rate of Major Urogenital Bleeding

    Time frame: From treatment initiation until end of follow-up; up to 20 months

    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  7. Incidence Rate of Major Other Bleeding

    Time frame: From treatment initiation until end of follow-up; up to 20 months

    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  8. Incidence Rate of Transient Ischemic Attack

    Time frame: From treatment initiation until end of follow-up; up to 20 months

    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  9. Incidence Rate of Major Upper Gastrointestinal Bleeding

    Time frame: From treatment initiation until end of follow-up; up to 20 months

    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.

  10. Incidence Rate of Stroke or Systemic Embolism

    Time frame: From treatment initiation until end of follow-up; up to 20 months

    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  11. Incidence Rate of Systemic Embolism

    Time frame: From treatment initiation until end of follow-up; up to 20 months

    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  12. Incidence Rate of Ischemic Stroke

    Time frame: From treatment initiation until end of follow-up; up to 20 months

    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  13. Incidence Rate of Hemorrhagic Stroke

    Time frame: From treatment initiation until end of follow-up; up to 20 months

    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  14. Incidence Rate of Stroke Uncertain Classification

    Time frame: From treatment initiation until end of follow-up; up to 20 months

    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9.

  15. Incidence Rate of Major Intracranial Bleeding

    Time frame: From treatment initiation until end of follow-up; up to 20 months

    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.

  16. Incidence Rate of Major Extracranial Bleeding

    Time frame: From treatment initiation until end of follow-up; up to 20 months

    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.

  17. Incidence Rate of Major Gastrointestinal Bleeding

    Time frame: From treatment initiation until end of follow-up; up to 20 months

    Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Comparative Effectiveness of Oral Anticoagulants: A Cohort Study

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 7, 2013
Registry last updated
Jun 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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