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

NCT05027061 | Completed

• 1 other identifier: CV185-771
• Study Type: observational
• Target: 11,776
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Valvular Atrial Fibrillation (NVAF)

Keywords

BMS-562247; Apixaban; Atrial fibrillation; Oral Anticoagulants; Japan; Retrospective Study

Outcome Measures

Primary Outcomes (29)

• Specialization of the treating physician

  At Baseline

• Distribution of socio-demographic characteristics of NVAF participants: Age group

  At Baseline

• Distribution of socio-demographic characteristics of NVAF participants: Gender

  At Baseline

• Distribution of socio-demographic characteristics of NVAF participants: Body weight

  At Baseline

• Distribution of socio-demographic characteristics of NVAF participants: Height

  At Baseline

• Distribution of socio-demographic characteristics of NVAF participants: Body mass index (BMI)

  At Baseline

• Distribution of outcomes of NVAF participants: Drinking information

  At Baseline

• Distribution of outcomes of NVAF participants: Smoking information

  At Baseline

• Distribution of outcomes of NVAF participants: Internal medical device information

  At Baseline

• Distribution of outcomes of NVAF participants: Degree of life freedom

  At Baseline

• Distribution of outcomes of NVAF participants: Hospitalization/outpatient status

  At Baseline

• Distribution of outcomes of NVAF participants: Systolic and diastolic blood pressure

  At Baseline

• Distribution of outcomes of NVAF participants: Pulse rate

  At Baseline

• Distribution of clinical characteristics of NVAF participants: Risk factors for stroke

  At Baseline

• Distribution of clinical characteristics of NVAF participants: Risk factors for bleeding

  At Baseline

• Distribution of clinical characteristics of NVAF participants: Comorbidities

  At Baseline

• Distribution of outcomes of NVAF participants: OAC prescription and administration status

  At Baseline

• Distribution of medication prescribed during baseline: angiotensin-converting enzyme inhibitor (ACE)

  At Baseline

• Distribution of medication prescribed during baseline: angiotensin-receptor blocker (ARB)

  At Baseline

• Distribution of medication prescribed during baseline: calcium antagonist

  At Baseline

• Distribution of medication prescribed during baseline: Antiarrhythmic drug

  At Baseline

• Distribution of medication prescribed during baseline: Statin

  At Baseline

• Distribution of medication prescribed during baseline: proton pump inhibitor (PPI)

  At Baseline

• Distribution of medication prescribed during baseline: H2-receptor antagonist

  At Baseline

• Distribution of medication prescribed during baseline: aspirin

  At Baseline

• Distribution of medication prescribed during baseline: P2Y12 inhibitor

  At Baseline

• Distribution of medication prescribed during baseline: Other antiplatelet drugs

  At Baseline

• Distribution of medication prescribed during baseline: Other anticoagulants

  At Baseline

• Distribution of medication prescribed during baseline: P-glycoprotein inhibitor

  At Baseline

Study Arms (6)

Cohort 1

Non-valvular atrial fibrillation (NVAF) participants receiving oral anticoagulant - Warfarin

Cohort 2

NVAF participants receiving oral anticoagulant - Apixaban

Cohort 3

NVAF participants receiving oral anticoagulant - Dabigatran

Cohort 4

NVAF participants receiving oral anticoagulant - Edoxaban

Cohort 5

NVAF participants receiving oral anticoagulant - Rivaroxaban

Cohort 6

NVAF participants not receiving oral anticoagulants

Eligibility Criteria

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

Study Population

The study population will consist of an estimated 12,000 Non-valvular atrial fibrillation (NVAF) participants' medical charts that will fulfill the study eligibility criteria.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution

Tokyo, 1070052, Japan

Location

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: August 26, 2021
• First Posted: August 30, 2021
• Study Start: April 2, 2021
• Primary Completion: December 4, 2021
• Study Completion: December 4, 2021
• Last Updated: March 17, 2022

Record last verified: 2022-02

Locations

JP (1)