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

Non-Valvular Atrial Fibrillation Clinical Trial

— ARISTOPHANES  

Official title:

Real-World Comparative Effectiveness Research and Related Economic Outcomes Among Nonvalvular Atrial Fibrillation Patients Using Oral Anti-coagulants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03087487
• Other study ID #: CV185-543
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: March 8, 2023

Study information

• Verified date: December 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 466991
• Est. completion date: March 8, 2023
• Est. primary completion date: September 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-Valvular Atrial Fibrillation

Locations

Country	Name	City	State
United States	Local Institution	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first major bleeding event		Up to 33 months
Primary	Time to first stroke/systemic embolism (SE) event		Up to 33 months
Secondary	Major bleeding-related medical costs		Up to 33 months
Secondary	Stroke/SE-related medical costs		Up to 33 months
Secondary	All-cause Healthcare costs		Up to 33 months

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls