Comparative Effectiveness of Oral Anticoagulants

NCT ID: NCT01847547

Last Updated: 2014-06-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5982 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-04-30

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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Dabigatran

No interventions assigned to this group

Warfarin

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Other Identifiers

1160.157

Identifier Type: -

Identifier Source: org_study_id