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Completed

NCT Number: NCT02982863

Treatment Pattern of Oral Anticoagulants (OAC) in Japan

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NISED Center

Tokyo, Shinagawa, 1416017, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Patients by Each Type of Study-target OAC Drug Prescribed for New Users of Anticoagulants With NVAF

    Time frame: 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)

  2. Number of Patients Prescribed OAC Drug Dabigatran by Dosage

    Time frame: 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.

  3. Number of Patients Prescribed OAC Drug Warfarin by Dosage

    Time frame: 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.

  4. Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage

    Time frame: 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.

  5. Number of Patients Prescribed OAC Drug Apixaban by Dosage

    Time frame: 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.

  6. Number of Patients Prescribed OAC Drug Edoxaban by Dosage

    Time frame: 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.

Secondary outcomes

  1. Baseline Characteristics: Age

    Time frame: 1 day

    Baseline characteristics of patients in each treatment group: age

  2. Baseline Characteristics: Gender

    Time frame: Day 1

    Baseline characteristics of patients in each treatment group: gender

  3. Baseline Characteristics: Year of Initiating Treatment

    Time frame: Day 1

    Baseline characteristics of patients in each treatment group: year of initiating treatment

  4. Baseline Characteristics: Speciality of Prescribers of OAC

    Time frame: Day 1

    Baseline characteristics of patients in each treatment group: speciality of prescribers of OAC.

    int.= internal; Med.= Medicine

  5. Baseline Characteristics: History of Disease

    Time frame: Day 1

    Baseline characteristics of patients in each treatment group: history of disease and hospitalization.

  6. Baseline Characteristics: History of Hospitalization

    Time frame: Day 1

    Baseline characteristics: history of hospitalization

  7. Baseline Characteristics: AF Risk Score

    Time frame: 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.

  8. Baseline Characteristics: Concomitant Medication

    Time frame: Day 1

    Baseline characteristics of patients in each treatment group:

    concomitant medication

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 6, 2016
Registry last updated
Sep 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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