Evaluation of Safety and Effectiveness on Oral Anticoagulants

NCT03765242 | Completed

• 1 other identifier: CV185-698
• Study Type: observational
• Target: 12,354
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to compare the risk of major bleeding among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating treatment

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Incidence of major bleeding among oral anticoagulant (OAC) initiators

  Maximum 3 years

Secondary Outcomes (10)

• Incidence of thromboembolic events

  Maximum 3 years

• Incidence of stoke/SE (secondary event) among OAC initiators

  Maximum 3 years

• Incidence of major bleeding and stoke/SE (secondary event) among OAC initiators stratified by CCr

  Maximum 3 years

• Incidence of cardiovascular/all cause death among OAC initiators

  Maximum 3 years

• Incidence of myocardial infarction among OAC initiators

  Maximum 3 years

Study Arms (2)

Patient initiating warfarin

Other: Non-Interventional

Patient initiating apixaban

Other: Non-Interventional

Interventions

Non-Interventional OTHER

Non-Interventional

Patient initiating apixaban; Patient initiating warfarin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients' medical charts with newly initiating warfarin or apixaban within the identification period fulfilling the study eligibility criteria

You may qualify if:

• Individuals greater than or equal to 20 years old as of the index date
• At least 1 diagnosis of NVAF prior to or on index date, identified by any medical records
• Newly treated with warfarin or apixaban between 01-Jan-2011 to 31-Dec-2016. The first warfarin or apixaban prescription date during the identification period will be designated as the index date

You may not qualify if:

• Patient's medical records indicating pregnancy during the follow-up period
• Patient's medical records indicating taking warfarin, apixaban, dabigatran, rivaroxaban, or edoxaban during the 6-months prior to the index date
• Had \> 1 OAC prescription in the patient's medical records on the index date

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Pfizer: collaborator

Study Sites (1)

Local Institution

Minato-ku, Tokyo, 1080074, Japan

Location

Related Publications (1)

• Morimoto T, Hoshino H, Matsuo Y, Ibuki T, Miyata K, Koretsune Y. Safety and Effectiveness of Apixaban Versus Warfarin in Japanese Patients with Nonvalvular Atrial Fibrillation Stratified by Renal Function: A Retrospective Cohort Study. Am J Cardiovasc Drugs. 2023 Nov;23(6):721-733. doi: 10.1007/s40256-023-00611-7. Epub 2023 Oct 17.

  PMID: 37847442 DERIVED

Related Links

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

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

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: November 26, 2018
• First Posted: December 5, 2018
• Study Start: September 21, 2018
• Primary Completion: December 25, 2020
• Study Completion: December 25, 2020
• Last Updated: May 13, 2022

Record last verified: 2022-05

Locations

JP (1)