Comparative Effectiveness of Oral Anticoagulants

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT01847547
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-05-02
• Study First Posted: 2013-05-07
• Status Verified: 2014-04
• Results First Submitted: 2014-04-22
• Results First Submitted QC: 2014-04-22
• Results First Posted: 2014-05-19
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5982

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence Rate of Stroke	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.
Incidence Rate of Major Bleeding	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 Outcome Measures

Name	Time	Method
Incidence Rate of Myocardial Infarction	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.
Incidence Rate of Venous Thromboembolism	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.
Incidence Rate of Major Urogenital Bleeding	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.
Incidence Rate of Major Other Bleeding	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.
Incidence Rate of Transient Ischemic Attack	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.
Incidence Rate of Major Lower Gastrointestinal Bleeding	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.
Incidence Rate of Major Upper Gastrointestinal Bleeding	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.
Incidence Rate of Stroke or Systemic Embolism	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.
Incidence Rate of Systemic Embolism	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.
Incidence Rate of Ischemic Stroke	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.
Incidence Rate of Hemorrhagic Stroke	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.
Incidence Rate of Stroke Uncertain Classification	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.
Incidence Rate of Deep Vein Thrombosis	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.
Incidence Rate of Pulmonary Embolism	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.
Incidence Rate of Major Intracranial Bleeding	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.
Incidence Rate of Major Extracranial Bleeding	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.
Incidence Rate of Major Gastrointestinal Bleeding	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.