Treatment Pattern of Oral Anticoagulants (OAC) in Japan

Atrial Fibrillation Clinical Trial

Official title:

Treatment Patterns of Newly Initiated Oral Anticoagulants on Japanese Non-valvular Atrial Fibrillation Patients Using a Japanese Claims Database

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02982863
• Other study ID #: 1160-0279
• Status: Completed
• Start date: December 1, 2016
• Est. completion date: December 1, 2016

Study information

• Verified date: September 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48696
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients aged >18 year-old with confirmed diagnosis of NVAF (ICD 10 code I48), being new starters of either dabigatran, warfarin, apixaban or edoxaban, having no prescription of other OACs for12 months prior to the index date (defined as the first prescription of OACs (the period is defined as baseline period)), and having an index date between 14 Mar 2011 to 30 June 2016

Exclusion criteria:

• Patients having less than 12 months of enrolment prior to the index date , being dialysis or kidney transplant recipients in baseline period, having either atrial flutter, valvular AF, mechanical valve placement, rheumatic AF, and/or mitral valve prolapse/regurge/stenosis in baseline period, and having record of deep vein thrombosis or pulmonary embolism < 6 months before Atrial Fibrillation (AF) diagnosis in baseline period

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Japan	NISED Center	Tokyo, Shinagawa

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients by Each Type of Study-target OAC Drug Prescribed for New Users of Anticoagulants With NVAF	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)	Day 1
Primary	Number of Patients Prescribed OAC Drug Dabigatran by Dosage	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.	Day 1
Primary	Number of Patients Prescribed OAC Drug Warfarin by Dosage	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.	Day 1
Primary	Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage	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.	Day 1
Primary	Number of Patients Prescribed OAC Drug Apixaban by Dosage	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.	Day 1
Primary	Number of Patients Prescribed OAC Drug Edoxaban by Dosage	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.	Day 1
Secondary	Baseline Characteristics: Age	Baseline characteristics of patients in each treatment group: age	1 day
Secondary	Baseline Characteristics: Gender	Baseline characteristics of patients in each treatment group: gender	Day 1
Secondary	Baseline Characteristics: Year of Initiating Treatment	Baseline characteristics of patients in each treatment group: year of initiating treatment	Day 1
Secondary	Baseline Characteristics: Speciality of Prescribers of OAC	Baseline characteristics of patients in each treatment group: speciality of prescribers of OAC.; int.= internal; Med.= Medicine	Day 1
Secondary	Baseline Characteristics: History of Disease	Baseline characteristics of patients in each treatment group: history of disease and hospitalization.	Day 1
Secondary	Baseline Characteristics: History of Hospitalization	Baseline characteristics: history of hospitalization	Day 1
Secondary	Baseline Characteristics: AF Risk Score	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.	Day 1
Secondary	Baseline Characteristics: Concomitant Medication	Baseline characteristics of patients in each treatment group: concomitant medication	Day 1

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