CompletedNCT03508271Updated Jan 4, 2019

Effectiveness of Oral Anticoagulants in Elderly Patients With Non-Valvular Atrial Fibrillation and Heart Failure

An observational study in Atrial Fibrillation and Heart Failure, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2019-01-04.

Sponsored by Bristol-Myers Squibb · Observational

Study type: Observational
Model: Cohort
Time perspective: Retrospective
Enrollment: 60,000
Ages: 65 Years and older
Sex: All

Study summary

Observational study of elderly individuals diagnosed with Non-Valvular Atrial Fibrillation and Heart Failure who are beginning oral blood thinners

Conditions studied

Atrial Fibrillation
Heart Failure

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In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 60,000 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.

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Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 65 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Elderly individuals diagnosed with NVAF (non-valvular atrial fibrillation) and HF (heart failure) who are new initiators of DOAC's (direct oral anticoagulants)

Inclusion criteria

Were age greater than or equal to 65 years as of the index date
Had greater than or equal to 1 diagnosis of AF prior to or on the index date
Had greater than or equal to 1 diagnosis claim of HF during the 12 months prior to or on the index date
Had 1 or more pharmacy claim for oral blood thinners

Exclusion criteria

Exclusion Criteria:

Claims indicating diagnosis or procedure for hip/knee replacement surgery within 6 weeks prior to index date
Pharmacy claim for warfarin, apixaban, dabigatran, edoxaban or rivaroxaban during the 12-month baseline period
Greater than 1 oral anticoagulants prescription claim on the index date and/or with a follow-up less than 1 day
Had medical claim indicating VTE in the 12 months prior to index date

Other protocol defined inclusion/exclusion criteria could apply

Study design

Observational model: Cohort
Time perspective: Retrospective
Enrollment: 60,000 participants (actual)
Patient registry: No

Groups and cohorts

Elderly individuals with NVAF and HF who are taking OAC's
Other: Non-Interventional

Interventions

OtherNon-Interventional
Non-Interventional

What researchers measure

Primary outcomes

Incidence of stroke/systemic embolism (SE)
Time frame: Approximately 195 weeks
Incidence of major bleeding
Time frame: Approximately 195 weeks

Secondary outcomes

Incidence of miocardial infarction (MI)
Time frame: Approximately 195 weeks
Incidence of all cause mortality
Time frame: Approximately 195 weeks
Incidence of all cause hospitalization
Time frame: Approximately 195 weeks
Incidence of major adverse cardiac event
Time frame: Approximately 195 weeks

Study locations

1 site

Local Institution
Ann Arbor, Michigan 48104, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03508271
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Apr 25, 2018
Start date: Nov 30, 2017
Primary completion: Nov 8, 2018
Completion: Nov 8, 2018
Last update: Jan 4, 2019

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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