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Non-Interventional Study Describing Direct Costs Related to Anti-coagulation Treatment

5. maj 2022 opdateret af: Pfizer

Non-interventional Study Describing Direct Costs Related to Anticoagulation Treatment in Patients With Nonvalvular Atrial Fibrillation (NVAF) in Secondary Stroke Prevention Prescribed Apixaban or Warfarin Treatment

To describe the direct costs related to warfarin/apixaban treatment

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

To describe the direct costs related to warfarin/apixaban treatment during the first 6 months of the secondary stroke prevention in NVAF patients.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

109

Kontakter og lokationer

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

Studiesteder

  • Tjekkiet
      • Praha 5, Tjekkiet, 150 06
        • Fakultni nemocnice Motol

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, OLDER_ADULT)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

NVAF patients, who used either warfarin or apixaban as a secondary stroke/TIA prevention.

Beskrivelse

Inclusion Criteria:

  • Diagnosis of non-valvular atrial fibrillation (NVAF);
  • New initiation of anticoagulation therapy (apixaban or warfarin) due to the ischemic event (stroke/TIA) meaning patients previously not anticoagulated due to diagnosis of NVAF;
  • Indication to anticoagulation therapy as a secondary stroke prevention within 7 to 30 days after the stroke/TIA event;
  • Apixaban arm: genetically determined higher sensitivity to warfarin;
  • Patients whose status allowed oral treatment with apixaban/warfarin;
  • Age ≥ 18;
  • Access to patient´s records of the first 6 months of the warfarin/apixaban treatment.

Exclusion Criteria:

  • Diagnosis of valvular disease;
  • Treatment with other anticoagulants in previous 6 months due to other the NVAF indication;
  • Treatment or prophylaxis of deep vein thrombosis or pulmonary embolism;
  • Contraindications according SmPC of Eliquis

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Non-valvular Atrial Fibrillation (NVAF) on warfarin
The study follows two cohorts of Non-valvular Atrial Fibrillation (NVAF) patients, who used warfarin as a secondary stroke/TIA prevention.
Non-valvular Atrial Fibrillation (NVAF) on apixaban
The study follows two cohorts of Non-valvular Atrial Fibrillation (NVAF) patients, who used apixaban as a secondary stroke/TIA prevention.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
CHA2-DS2-VASc Score at Baseline
Tidsramme: Baseline (fra retrospektive data hentet i undersøgelsen)
CHA2DS2-VASc scoringsskala blev brugt til at estimere risikoen for slagtilfælde og systemiske emboli hos deltagere med NVAF. CHA2DS2-VASc-score blev beregnet ud fra 8 risikofaktorer (alder 65-74 år, alder >=75 år, kønskategori, dvs. kvindeligt køn, kongestiv hjertesvigt historie, hypertension historie, slagtilfælde/TIA/tromboembolisme historie, karsygdomshistorie og diabetes mellitus historie). Samlet CHA2DS2-VASc-score varierede fra 0-9, hvor 0 = lav risiko og 9 = høj risiko for slagtilfælde.
Baseline (fra retrospektive data hentet i undersøgelsen)
HAS-BLED Score at Baseline
Tidsramme: Baseline (from retrospective data retrieved in the study)
HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and >=3 = high risk of bleed.
Baseline (from retrospective data retrieved in the study)
CHA2-DS2-VASc Score at Month 6
Tidsramme: Month 6 (from retrospective data retrieved in the study)
CHA2DS2-VASc scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age >=75 years, sex category i.e. female sex, congestive heart failure history, hypertension history, stroke/TIA/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke.
Month 6 (from retrospective data retrieved in the study)
HAS-BLED Score at Month 6
Tidsramme: Month 6 (from retrospective data retrieved in the study)
HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and >=3 = high risk of bleed.
Month 6 (from retrospective data retrieved in the study)
Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment
Tidsramme: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, percentage of participants were categorized according to number of outpatient visits from 0 to 5.
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Outpatient Visits During First 6 Months of Treatment
Tidsramme: Op til de første 6 måneders behandling (fra retrospektive data hentet i undersøgelsen)
Omkostninger til ambulante besøg blev beregnet for de første 6 måneders behandling som antallet af besøg ganget med omkostningerne ved besøget (450,0 tjekkiske koruna [CZK] pr. besøg). Omkostningerne blev beregnet ud fra antallet af ambulante besøg under behandlingen.
Op til de første 6 måneders behandling (fra retrospektive data hentet i undersøgelsen)
Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment
Tidsramme: Op til de første 6 måneders behandling (fra retrospektive data hentet i undersøgelsen)
INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. In this outcome measure, percentage of participants were categorized according to number of INR measurements included zero (0), 1 to 9, 10 to 19 and greater than or equal to (>=) 20.
Op til de første 6 måneders behandling (fra retrospektive data hentet i undersøgelsen)
Cost of INR Measurements During First 6 Months of Treatment
Tidsramme: Up to first 6 months of treatment (from retrospective data retrieved in the study)
INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. Costs related to INR measurements, were calculated for the period of 6 months as the number of INR measurements multiplied by the cost of the INR measurement (213.0 CZK per measurement). Costs were based on the expenditure of total number of INR measurements during first 6-month treatment.
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Dosage of Warfarin and Apixaban at the Initiation of the Treatment
Tidsramme: Baseline (fra retrospektive data hentet i undersøgelsen)
In this outcome measure, dosage of apixaban and warfarin used at the initiation of treatment was reported.
Baseline (fra retrospektive data hentet i undersøgelsen)
Dosage of Warfarin and Apixaban During First 6 Months of Treatment
Tidsramme: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, dosage of apixaban and warfarin used during first 6 months of treatment was reported.
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Medication During First 6 Months of Treatment
Tidsramme: Op til de første 6 måneders behandling (fra retrospektive data hentet i undersøgelsen)
In this outcome measure, cost of medication, i.e., costs of apixaban and warfarin were based on the dosage of active substance and were calculated for the first 6 months of treatment (daily cost times 182.4 days), regardless of how long the individual participant treated was reported.
Op til de første 6 måneders behandling (fra retrospektive data hentet i undersøgelsen)
Percentage of Participants Categorized According to Number of Hospital Admissions
Tidsramme: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, percentage of participants were categorized according to number of hospital admissions from 0 to 3 were reported.
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Hospital Admissions During First 6 Months of Treatment
Tidsramme: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, costs of hospital admissions were based on the number of hospital admissions during the treatment period by considering the reason for hospitalization. If the reason for admission was not related to the recorded event (ischemic, hemorrhagic, or other adverse event), or the participant experienced none of these events, the cost of hospitalization was calculated as the number of days multiplied by the cost per a day of hospitalization (1898.2 CZK per day).
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Percentage of Participants Categorized According to Number of Diagnostic Procedures
Tidsramme: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, percentage of participants were categorized according to number of diagnostic procedures.
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Procentdel af deltagere kategoriseret efter type iskæmiske hændelser i løbet af de første 6 måneders behandling
Tidsramme: Op til de første 6 måneders behandling (fra retrospektive data hentet i undersøgelsen)
I dette resultatmål blev procentdelen af ​​deltagerne kategoriseret efter type af iskæmiske hændelser, som inkluderede hjerteiskæmi og slagtilfælde/TIA.
Op til de første 6 måneders behandling (fra retrospektive data hentet i undersøgelsen)
Cost of Ischemic Events During First 6 Months of Treatment
Tidsramme: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Costs of ischemic events (cardiac ischemia and stroke/TIA) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of ischemic events during the first 6 months of treatment.
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Percentage of Participants Categorized With Major Hemorrhagic Events During First 6 Months of Treatment
Tidsramme: Op til de første 6 måneders behandling (fra retrospektive data hentet i undersøgelsen)
In this outcome measure, percentage of participants with major hemorrhagic events which included intracranial bleeding was reported.
Op til de første 6 måneders behandling (fra retrospektive data hentet i undersøgelsen)
Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment
Tidsramme: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, percentage of participants were categorized according to type of minor hemorrhagic events which included epistaxis, gastrointestinal (GI) bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe.
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Major Hemorrhagic Events During First 6 Months of Treatment
Tidsramme: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Costs of major hemorrhagic events (intracranial bleeding) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of major hemorrhagic events during the first 6 months of treatment.
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Minor Hemorrhagic Events During First 6 Months of Treatment
Tidsramme: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Costs of minor hemorrhagic events (epistaxis, GI bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of minor hemorrhagic events during the first 6 months of treatment.
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Number of Participants With Other Adverse Events During First 6 Months of Treatment
Tidsramme: Op til de første 6 måneders behandling (fra retrospektive data hentet i undersøgelsen)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Other adverse events included all events other than ischemic, major and minor hemorrhagic events.
Op til de første 6 måneders behandling (fra retrospektive data hentet i undersøgelsen)
Cost of Other Adverse Events During First 6 Months of Treatment
Tidsramme: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Costs of other adverse events included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the number of other adverse events during the treatment.
Up to first 6 months of treatment (from retrospective data retrieved in the study)
Percentage of Participants Who Died (Treatment-Related) During First 6 Months of Treatment
Tidsramme: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, percentage of participants who died due to the given treatment were reported.
Up to first 6 months of treatment (from retrospective data retrieved in the study)

Samarbejdspartnere og efterforskere

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

Sponsor

Pfizer

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)

4. august 2020

Primær færdiggørelse (FAKTISKE)

31. maj 2021

Studieafslutning (FAKTISKE)

31. maj 2021

Datoer for studieregistrering

Først indsendt

15. juni 2020

Først indsendt, der opfyldte QC-kriterier

15. juni 2020

Først opslået (FAKTISKE)

17. juni 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (FAKTISKE)

8. februar 2023

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2022

Sidst verificeret

1. maj 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B0661121
  • APIXABAN SECOND LINE (ANDET: Alias Study Number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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