A Real-World Comparison of Safety and Effectiveness of Novel Oral Anti-Coagulant (NOAC) Naïve and Warfarin Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage

Atrial Fibrillation Clinical Trial

Official title:

Real-World Comparisons of Bleeding Among Novel Oral Anticoagulant (NOAC)-Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage, Who Newly Initiated Novel Oral Anticoagulation Therapies or Were Treated With Warfarin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03189069
• Other study ID #: CV185-583
• Status: Completed
• Start date: October 6, 2016
• Est. completion date: May 31, 2017

Study information

• Verified date: January 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary purpose of this study is to evaluate the risk of major bleeding and stroke/systemic embolism (SE) among novel oral anti-coagulant (OAC) naïve and warfarin naïve Medicare Advantage patients with non-valvular atrial fibrillation (NVAF) treated with apixaban, dabigatran, rivaroxaban, or warfarin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36000
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Had at least 1 pharmacy claim for warfarin, apixaban, dabigatran, or rivaroxaban during the identification period (01-Jan-2013 through 31-Dec-2015)

• Had continuous health plan enrollment with medical and pharmacy benefits for 6 months pre-index date (baseline period)

• Had continuous health plan enrollment with medical and pharmacy benefits for at least 1 month following index date

• Had at least 1 medical claim for atrial fibrillation any time before or on index date

Exclusion Criteria:

• Had medical claims with a diagnosis code for rheumatic mitral valvular heart disease, mitral valve stenosis or heart valve replacement/transplant during the 6-month baseline period

• Had medical claims with a diagnosis code for dialysis, kidney transplant, or end-stage chronic kidney disease during the 6 month baseline period

• Had medical claims indicating a diagnosis of venous thromboembolism during the 6-month baseline period

• Had claims indicating a diagnosis or procedure code of hip or knee replacement surgery within 6 weeks prior to the index date

• Had claims for a diagnosis or procedure code for reversible atrial fibrillation

• Had medical claims indicating pregnancy during the study period

• Had a pharmacy claim for warfarin, apixaban, dabigatran, edoxaban, or rivaroxaban during the 6-month baseline period

• Had > 1 oral anticoagulant prescription claim on the index date

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Apixaban
Treatment for NVAF patients
• Dabigatran
Treatment for NVAF patients
• Rivaroxaban
Treatment for NVAF patients
• Warfarin
Treatment for NVAF patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major bleeding		36 months

External Links

•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form