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

NCT03189069 | Completed

• 1 other identifier: CV185-583
• Study Type: observational
• Target: 36,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Major bleeding

  36 months

Study Arms (4)

Patients prescribed apixaban

Drug: Apixaban

Patients prescribed dabigatran

Drug: Dabigatran

Patients prescribed rivaroxaban

Drug: Rivaroxaban

Patients prescribed warfarin

Drug: Warfarin

Interventions

Apixaban DRUG

Treatment for NVAF patients

Patients prescribed apixaban

Dabigatran DRUG

Treatment for NVAF patients

Patients prescribed dabigatran

Rivaroxaban DRUG

Treatment for NVAF patients

Patients prescribed rivaroxaban

Warfarin DRUG

Treatment for NVAF patients

Patients prescribed warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be selected from the MORE Registry according to the inclusion/exclusion criteria. Four different cohorts will be evaluated: patients who were prescribed warfarin, apixaban, dabigatran or rivaroxaban. Only users of oral anticoagulant treatment from January 1, 2013 to January 1, 2016 will be included in this study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• Investigator Inquiry Form

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

apixaban; Dabigatran; Rivaroxaban; Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 16, 2017
• Study Start: October 6, 2016
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: January 30, 2019

Record last verified: 2019-01