Evaluation of Safety and Effectiveness on Oral Anticoagulants

NCT ID: NCT03765242

Last Updated: 2022-05-13

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

12354 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-21

Study Completion Date

2020-12-25

Brief Summary

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

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patient initiating warfarin

Non-Interventional

Intervention Type OTHER

Non-Interventional

Patient initiating apixaban

Non-Interventional

Intervention Type OTHER

Non-Interventional

Interventions

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Non-Interventional

Non-Interventional

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

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

Minato-ku, Tokyo, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 37847442 (View on PubMed)

Related Links

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Other Identifiers

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CV185-698

Identifier Type: -

Identifier Source: org_study_id

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