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Treatment Pattern of Oral Anticoagulants (OAC) in Japan

7. september 2018 opdateret af: Boehringer Ingelheim

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

  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

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

48696

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Japan
      • Tokyo, Shinagawa, Japan, 1416017
        • NISED Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Medical Data Vision (MDV) clinical database

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Tilbagevirkende kraft

Kohorter og interventioner

Gruppe / kohorte
All Patients

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Patients by Each Type of Study-target OAC Drug Prescribed for New Users of Anticoagulants With NVAF
Tidsramme: 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)
Day 1
Number of Patients Prescribed OAC Drug Dabigatran by Dosage
Tidsramme: 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.
Day 1
Number of Patients Prescribed OAC Drug Warfarin by Dosage
Tidsramme: 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.
Day 1
Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage
Tidsramme: 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.
Day 1
Number of Patients Prescribed OAC Drug Apixaban by Dosage
Tidsramme: 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.
Day 1
Number of Patients Prescribed OAC Drug Edoxaban by Dosage
Tidsramme: 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.
Day 1

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Baseline Characteristics: Age
Tidsramme: 1 day
Baseline characteristics of patients in each treatment group: age
1 day
Baseline Characteristics: Gender
Tidsramme: Day 1
Baseline characteristics of patients in each treatment group: gender
Day 1
Baseline Characteristics: Year of Initiating Treatment
Tidsramme: Day 1
Baseline characteristics of patients in each treatment group: year of initiating treatment
Day 1
Baseline Characteristics: Speciality of Prescribers of OAC
Tidsramme: Day 1

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

int.= internal; Med.= Medicine
Day 1
Baseline Characteristics: History of Disease
Tidsramme: Day 1
Baseline characteristics of patients in each treatment group: history of disease and hospitalization.
Day 1
Baseline Characteristics: History of Hospitalization
Tidsramme: Day 1
Baseline characteristics: history of hospitalization
Day 1
Baseline Characteristics: AF Risk Score
Tidsramme: 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.
Day 1
Baseline Characteristics: Concomitant Medication
Tidsramme: Day 1

Baseline characteristics of patients in each treatment group:

concomitant medication
Day 1

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2016

Primær færdiggørelse (Faktiske)

1. december 2016

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

29. november 2016

Først indsendt, der opfyldte QC-kriterier

1. december 2016

Først opslået (Skøn)

6. december 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. september 2018

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1160-0279

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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