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

NCT ID: NCT03087487

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

466991 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2023-03-08

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Valvular Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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NVAF patients on Warfarin

NVAF patients newly initiated with Warfarin. Non-Interventional.

No interventions assigned to this group

NVAF patients on Apixaban

NVAF patients newly initiated on Apixaban. Non-Interventional.

No interventions assigned to this group

NVAF patients on Dabigatran

NVAF patients newly initiated with Dabigatran. Non-Interventional.

No interventions assigned to this group

NVAF patients on Rivaroxaban

NVAF patients newly initiated with Rivaroxaban. Non-Interventional.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Lip GYH, Keshishian AV, Kang AL, Li X, Dhamane AD, Luo X, Balachander N, Rosenblatt L, Mardekian J, Nadkarni A, Pan X, Di Fusco M, Garcia Reeves AB, Yuce H, Deitelzweig SB. Effectiveness and Safety of Oral Anticoagulants in Patients With Nonvalvular Atrial Fibrillation and Diabetes Mellitus. Mayo Clin Proc. 2020 May;95(5):929-943. doi: 10.1016/j.mayocp.2019.05.032.

Reference Type DERIVED
PMID: 32370854 (View on PubMed)

Lip GYH, Keshishian A, Li X, Hamilton M, Masseria C, Gupta K, Luo X, Mardekian J, Friend K, Nadkarni A, Pan X, Baser O, Deitelzweig S. Effectiveness and Safety of Oral Anticoagulants Among Nonvalvular Atrial Fibrillation Patients. Stroke. 2018 Dec;49(12):2933-2944. doi: 10.1161/STROKEAHA.118.020232.

Reference Type DERIVED
PMID: 30571400 (View on PubMed)

Li X, Keshishian A, Hamilton M, Horblyuk R, Gupta K, Luo X, Mardekian J, Friend K, Nadkarni A, Pan X, Lip GYH, Deitelzweig S. Apixaban 5 and 2.5 mg twice-daily versus warfarin for stroke prevention in nonvalvular atrial fibrillation patients: Comparative effectiveness and safety evaluated using a propensity-score-matched approach. PLoS One. 2018 Jan 26;13(1):e0191722. doi: 10.1371/journal.pone.0191722. eCollection 2018.

Reference Type DERIVED
PMID: 29373602 (View on PubMed)

Related Links

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Other Identifiers

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CV185-543

Identifier Type: -

Identifier Source: org_study_id

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