Treatment Pattern of Oral Anticoagulants (OAC) in Japan

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT02982863
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

1. To understand the treatment patterns of OACs and baseline patient characteristics of Japanese Non-Valvular Atrial Fibrillation (NVAF) patients

2. To determine whether warfarin and dabigatran new user group can be balanced using propensity score matching using pre-specified baseline covariates.

3. As an exploratory analysis, to assess mean duration of on-therapy follow-up time in database

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-29
• Study Start: 2016-12-01
• Primary Completion: 2016-12-01
• Study Completion: 2016-12-01
• Study First Submitted QC: 2016-12-01
• Study First Posted: 2016-12-06
• Results First Submitted: 2017-11-22
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-07
• Last Update Submitted: 2018-09-07
• Results First Posted: 2018-09-14
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48696

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients Prescribed OAC Drug Edoxaban by Dosage	Day 1	Number of patients prescribed OAC drug edoxaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.
Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage	Day 1	Number of patients prescribed OAC drug rivaroxaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.
Number of Patients Prescribed OAC Drug Warfarin by Dosage	Day 1	Number of patients prescribed OAC drug Warfarin at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.
Number of Patients Prescribed OAC Drug Dabigatran by Dosage	Day 1	Number of patients prescribed OAC drug dabigatran at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.
Number of Patients by Each Type of Study-target OAC Drug Prescribed for New Users of Anticoagulants With NVAF	Day 1	Number of patients by each type of study-target OAC drug (dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban) prescribed as the first Oral Anticoagulants (OAC) with Non-valvular atrial fibrillation (NVAF)
Number of Patients Prescribed OAC Drug Apixaban by Dosage	Day 1	Number of patients prescribed OAC drug Apixaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.

Secondary Outcome Measures

Name	Time	Method
Baseline Characteristics: Age	1 day	Baseline characteristics of patients in each treatment group: age
Baseline Characteristics: AF Risk Score	Day 1	Baseline characteristics of patients in each treatment group: Atrial Fibrillation (AF) risk score; CHADS2: Congestive heart failure, Hypertension, Age, Diabetes, Stroke(doubled). CHADS2 score range from 0-6, with higher scores indicating the higher risk; CHA2DS2VASc: Cardiac failure or dysfunction, Hypertension, Age 75 (doubled), Diabetes, Stroke (doubled) Vascular disease, Age 65-74 and Sex category (female) score. CHA2DS2VASc score range from 1-9, with higher scores indicating the higher risk.; HAS-BLED: Hypertension, Abnormal renal function, Abnormal hepatic function. HAS-BLED score range from 0-8, with higher scores indicating the higher risk.
Baseline Characteristics: Gender	Day 1	Baseline characteristics of patients in each treatment group: gender
Baseline Characteristics: History of Hospitalization	Day 1	Baseline characteristics: history of hospitalization
Baseline Characteristics: History of Disease	Day 1	Baseline characteristics of patients in each treatment group: history of disease and hospitalization.
Baseline Characteristics: Concomitant Medication	Day 1	Baseline characteristics of patients in each treatment group: concomitant medication
Baseline Characteristics: Year of Initiating Treatment	Day 1	Baseline characteristics of patients in each treatment group: year of initiating treatment
Baseline Characteristics: Speciality of Prescribers of OAC	Day 1	Baseline characteristics of patients in each treatment group: speciality of prescribers of OAC.; int.= internal; Med.= Medicine

Trial Locations

Locations (1)

NISED Center; 🇯🇵 Tokyo, Shinagawa, Japan