Treatment Pattern of Oral Anticoagulants (OAC) in Japan

NCT02982863 | Completed Results

• 1 other identifier: 1160-0279
• Study Type: observational
• Target: 48,696
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To understand the treatment patterns of OACs and baseline patient characteristics of Japanese Non-Valvular Atrial Fibrillation (NVAF) patients
2. 2.To determine whether warfarin and dabigatran new user group can be balanced using propensity score matching using pre-specified baseline covariates.
3. 3.As an exploratory analysis, to assess mean duration of on-therapy follow-up time in database

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (8)

• Baseline Characteristics: Age

  1 day

• Baseline Characteristics: Gender

  Day 1

• Baseline Characteristics: Year of Initiating Treatment

  Day 1

• Baseline Characteristics: Speciality of Prescribers of OAC

  Day 1

• Baseline Characteristics: History of Disease

  Day 1

Study Arms (1)

All Patients

Eligibility Criteria

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

Study Population

Medical Data Vision (MDV) clinical database

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

NISED Center

Tokyo, Shinagawa, 1416017, Japan

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Generalizability of findings may be limited outside of population. The data in Medical Data Vision Co., Ltd. (MDV) database is collected from DPC hospitals that may contain out-patient data with greater disease severity.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: December 6, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 14, 2018
• Results First Posted: September 14, 2018

Record last verified: 2018-09

Locations

JP (1)