Clinical and Economic Outcomes of Oral Anticoagulants in Non-valvular Atrial Fibrillation

Completed

• Conditions: Non-Valvular Atrial Fibrillation

• Registration Number: NCT03087487
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The primary objectives of this study are to compare the risk of major bleeding and stroke/systemic embolism (SE) events among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating OAC warfarin or apixaban or dabigatran or rivaroxaban treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2015-09-30
• Study First Submitted: 2017-03-17
• Study First Submitted QC: 2017-03-17
• Study First Posted: 2017-03-22
• Study Completion: 2023-03-08
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 466991

Inclusion Criteria

1. Had 1 or more pharmacy claim for apixaban or warfarin or dabigatran or rivaroxaban during the identification period (01-Jan-2013 to 30-Sep-2015). The first OAC pharmacy claim date during the identification period will be designated as the index date
2. Patients 18 years old or older as of the index date
3. At least 1 diagnosis of atrial fibrillation prior to or on index date, identified by any medical claim
4. At least 12 months of baseline period prior to index date with continuous enrollment

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Exclusion Criteria

1. Evidence of valvular heart disease, transient atrial fibrillation, venous thromboembolism during the 12-month baseline period or on the index date
2. Evidence of pregnancy during the study period
3. Had a pharmacy claim for warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 12-month baseline period
4. Had more than 1 oral anticoagulant claim on the index date

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first major bleeding event	Up to 33 months
Time to first stroke/systemic embolism (SE) event	Up to 33 months

Secondary Outcome Measures

Name	Time	Method
Major bleeding-related medical costs	Up to 33 months
Stroke/SE-related medical costs	Up to 33 months
All-cause Healthcare costs	Up to 33 months

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Ann Arbor, Michigan, United States