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

NCT03087487 | Completed

• 1 other identifier: CV185-543
• Study Type: observational
• Target: 466,991
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Valvular Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Time to first major bleeding event

  Up to 33 months

• Time to first stroke/systemic embolism (SE) event

  Up to 33 months

Secondary Outcomes (3)

• Major bleeding-related medical costs

  Up to 33 months

• Stroke/SE-related medical costs

  Up to 33 months

• All-cause Healthcare costs

  Up to 33 months

Study Arms (4)

NVAF patients on Warfarin

NVAF patients newly initiated with Warfarin. Non-Interventional.

NVAF patients on Apixaban

NVAF patients newly initiated on Apixaban. Non-Interventional.

NVAF patients on Dabigatran

NVAF patients newly initiated with Dabigatran. Non-Interventional.

NVAF patients on Rivaroxaban

NVAF patients newly initiated with Rivaroxaban. Non-Interventional.

Eligibility Criteria

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

Study Population

NVAF patients who were initiators of warfarin or apixaban or dabigatran or rivaroxaban treatment from 01-Jan-2013 through 30-Sep-2015. All patients who have at least 1 year of baseline data available and no prior OAC use will be included in this study.

You may qualify if:

• 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
• Patients 18 years old or older as of the index date
• At least 1 diagnosis of atrial fibrillation prior to or on index date, identified by any medical claim
• At least 12 months of baseline period prior to index date with continuous enrollment

You may not qualify if:

• Evidence of valvular heart disease, transient atrial fibrillation, venous thromboembolism during the 12-month baseline period or on the index date
• Evidence of pregnancy during the study period
• Had a pharmacy claim for warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 12-month baseline period
• Had more than 1 oral anticoagulant claim on the index date

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Ann Arbor, Michigan, 48104, United States

Location

Related Publications (3)

• 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.

  PMID: 32370854 DERIVED

• 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.

  PMID: 30571400 DERIVED

• 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.

  PMID: 29373602 DERIVED

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 22, 2017
• Study Start: June 1, 2016
• Primary Completion: February 26, 2023
• Study Completion: March 8, 2023
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

US (1)