Sequential Expansion of Comparative Effectiveness of Anticoagulants

Boehringer Ingelheim

Status: Completed

Conditions: Atrial Fibrillation

Study type: Observational

Funder types: Industry

Identifiers

NCT02081807

1160.207

Details and patient eligibility

About

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.

Enrollment: 221,228 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.
• Congestive Heart Failure, Hypertension, Age > 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease, Age 65-74, Sex Category (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

Trial design

221,228 participants in 2 patient groups

Dabigatran

Warfarin