A Study of Participants With Non-Valvular Atrial Fibrillation (NVAF) Treated or Untreated With Oral Anticoagulant in the National Cerebral and Cardiovascular Center (NCVC) in Japan

Non-Valvular Atrial Fibrillation (NVAF) Clinical Trial

Official title:

Retrospective Medical Chart Review Study for Non-valvular Atrial Fibrillation Patients Treated or Untreated With Oral Anticoagulant in the National Cerebral and Cardiovascular Center (NCVC) in Japan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05027061
• Other study ID #: CV185-771
• Status: Completed
• Start date: April 2, 2021
• Est. completion date: December 4, 2021

Study information

• Verified date: February 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this observational study is to understand real-world oral anticoagulants (OAC) (warfarin, apixaban, dabigatran, edoxaban and rivaroxaban) usage for non-valvular atrial fibrillation (NVAF) patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11776
• Est. completion date: December 4, 2021
• Est. primary completion date: December 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Participants received medical treatment for NVAF between 10-Jan-2012 and 31-Aug-2020.

Exclusion Criteria:

• Had no data of serum creatinine in the participant's medical records
• Had no data of body weight in the participant's medical records
• Were given oral anticoagulant (OAC) for treatment of diseases other than atrial fibrillation (AF) Other protocol-defined inclusion/exclusion criteria apply.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-Valvular Atrial Fibrillation (NVAF)

Locations

Country	Name	City	State
Japan	Local Institution	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specialization of the treating physician		At Baseline
Primary	Distribution of socio-demographic characteristics of NVAF participants: Age group		At Baseline
Primary	Distribution of socio-demographic characteristics of NVAF participants: Gender		At Baseline
Primary	Distribution of socio-demographic characteristics of NVAF participants: Body weight		At Baseline
Primary	Distribution of socio-demographic characteristics of NVAF participants: Height		At Baseline
Primary	Distribution of socio-demographic characteristics of NVAF participants: Body mass index (BMI)		At Baseline
Primary	Distribution of outcomes of NVAF participants: Drinking information		At Baseline
Primary	Distribution of outcomes of NVAF participants: Smoking information		At Baseline
Primary	Distribution of outcomes of NVAF participants: Internal medical device information		At Baseline
Primary	Distribution of outcomes of NVAF participants: Degree of life freedom		At Baseline
Primary	Distribution of outcomes of NVAF participants: Hospitalization/outpatient status		At Baseline
Primary	Distribution of outcomes of NVAF participants: Systolic and diastolic blood pressure		At Baseline
Primary	Distribution of outcomes of NVAF participants: Pulse rate		At Baseline
Primary	Distribution of clinical characteristics of NVAF participants: Risk factors for stroke		At Baseline
Primary	Distribution of clinical characteristics of NVAF participants: Risk factors for bleeding		At Baseline
Primary	Distribution of clinical characteristics of NVAF participants: Comorbidities		At Baseline
Primary	Distribution of outcomes of NVAF participants: OAC prescription and administration status		At Baseline
Primary	Distribution of medication prescribed during baseline: angiotensin-converting enzyme inhibitor (ACE)		At Baseline
Primary	Distribution of medication prescribed during baseline: angiotensin-receptor blocker (ARB)		At Baseline
Primary	Distribution of medication prescribed during baseline: calcium antagonist		At Baseline
Primary	Distribution of medication prescribed during baseline: Antiarrhythmic drug		At Baseline
Primary	Distribution of medication prescribed during baseline: Statin		At Baseline
Primary	Distribution of medication prescribed during baseline: proton pump inhibitor (PPI)		At Baseline
Primary	Distribution of medication prescribed during baseline: H2-receptor antagonist		At Baseline
Primary	Distribution of medication prescribed during baseline: aspirin		At Baseline
Primary	Distribution of medication prescribed during baseline: P2Y12 inhibitor		At Baseline
Primary	Distribution of medication prescribed during baseline: Other antiplatelet drugs		At Baseline
Primary	Distribution of medication prescribed during baseline: Other anticoagulants		At Baseline
Primary	Distribution of medication prescribed during baseline: P-glycoprotein inhibitor		At Baseline

External Links

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