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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03189069
• Collaborator: (none)
• Enrollment: 36,000
• Actual Duration (Months): 7.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: Apixaban; Drug: Dabigatran; Drug: Rivaroxaban; Drug: Warfarin

Study Design

• Study Type: Observational
• Actual Enrollment: 36000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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
• Actual Study Start Date: Oct 6, 2016
• Actual Primary Completion Date: May 31, 2017
• Actual Study Completion Date: May 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Patients prescribed apixaban	Drug: Apixaban; Treatment for NVAF patients
Patients prescribed dabigatran	Drug: Dabigatran; Treatment for NVAF patients
Patients prescribed rivaroxaban	Drug: Rivaroxaban; Treatment for NVAF patients
Patients prescribed warfarin	Drug: Warfarin; Treatment for NVAF patients

Outcome Measures

Primary Outcome Measures

1. Major bleeding [36 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03189069
• Other Study ID Numbers: CV185-583
• First Posted: Jun 16, 2017
• Last Update Posted: Jan 30, 2019
• Last Verified: Jan 1, 2019

• Additional relevant MeSH terms: Atrial Fibrillation; Warfarin; Rivaroxaban; Dabigatran; Apixaban

Study Results

No Results Posted as of Jan 30, 2019