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Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation

20. mars 2012 oppdatert av: AstraZeneca

A Controlled, Randomized, Parallel, Multicentre Study to Assess Safety and Tolerability of the Oral Direct Thrombin Inhibitor AZD0837, Given as an Extended-release Formulation, in the Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation

The main purpose of this study is to provide dose-guiding information by assessing the safety and tolerability of 4 different dosing regimens of an extended-release (ER) formulation of AZD0837 compared with well-controlled, dose-adjusted Vitamin-K antagonists (VKA) (aiming for an international normalized ratio (INR) 2.0 to 3.0) in patients with non-valvular atrial fibrillation (AF) with one or more additional risk factors for stroke.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

1084

Fase

  • Fase 2

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Nonvalvular AF (NVAF) verified by at least two ECGs in the last year separated by at least one week.
  • Previous cerebral ischemic attack (stroke or TIA, >30 days prior to randomization)
  • Previous systemic embolism.
  • Symptomatic congestive heart failure (CHF)
  • Impaired left ventricular systolic function
  • Diabetes mellitus
  • Hypertension requiring anti-hypertensive treatment.

Exclusion Criteria:

  • AF secondary to reversible disorders, eg hyperthyroidism, drugs and pulmonary embolism
  • Known contraindication to VKA treatment
  • Presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than AF requiring chronic anticoagulation treatment
  • Conditions associated with increased risk of major bleeding for example: history of intracranial bleeding, history of bleeding gastrointestinal disorder or major surgical procedure or trauma two weeks prior to randomization

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 1
AZD0837 450 mg
Legemiddel: AZD0837
ER tablet, PO, once daily for a period of 3-9 months.
Legemiddel: AZD0837
ER tablet, PO, twice daily for a period of 3-9 months
Eksperimentell: 2
AZD0837 200 mg
Legemiddel: AZD0837
ER tablet, PO, once daily for a period of 3-9 months.
Legemiddel: AZD0837
ER tablet, PO, twice daily for a period of 3-9 months
Eksperimentell: 3
AZD0837 300 mg
Legemiddel: AZD0837
ER tablet, PO, once daily for a period of 3-9 months.
Legemiddel: AZD0837
ER tablet, PO, twice daily for a period of 3-9 months
Eksperimentell: 4
AZD0837 150 mg
Legemiddel: AZD0837
ER tablet, PO, once daily for a period of 3-9 months.
Legemiddel: AZD0837
ER tablet, PO, twice daily for a period of 3-9 months
Aktiv komparator: 5
Vitamin-K antagonist at INR 2-3
Legemiddel: Vitamin-K antagonist at INR 2-3
Tablet, PO for a period of 3-9 months.
Andre navn:
  • Warfarin

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Bleeding Events
Tidsramme: 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)
Number of patients with a bleeding event while on study drug. Patients with multiple events are counted once
36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)
Creatinine
Tidsramme: 12 weeks according to protocol.(baseline to week 12 visit)
Change in Creatinine values from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)
12 weeks according to protocol.(baseline to week 12 visit)
Alanine Aminotransferase (ALAT)
Tidsramme: 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)
Number of patients while on study drug with ALAT>=3 times upper limit of normal.l
36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)
Bilirubin
Tidsramme: 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)
Number of patients while on study drug with Bilirubin>=2 times upper limit of normal
36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
D-Dimer
Tidsramme: 14 weeks according to protocol.(enrolment to week 12 visit)
Change in D-Dimer values from enrolment to week 12 visit for VKA naïve patients while on study drug (week 12 visit-enrolment)
14 weeks according to protocol.(enrolment to week 12 visit)
Activated Partial Thromboplastin Time (APTT)
Tidsramme: 12 weeks according to protocol.(baseline to week 12 visit)
Change in Activated partial thromboplastin time (APTT) from baseline to week 12 visit for VKA naïve patients while on study drug (week 12 visit-baseline)
12 weeks according to protocol.(baseline to week 12 visit)
Ecarin Clotting Time (ECT)
Tidsramme: 12 weeks according to protocol.(baseline to week 12 visit)
Change in Ecarin clotting time (ECT) from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)
12 weeks according to protocol.(baseline to week 12 visit)
Plasma Concentration of AZD0837 (Prodrug)
Tidsramme: 12 weeks after baseline according to protocol
Assessment made on the week 12 visit
12 weeks after baseline according to protocol
Plasma Concentration of AR-H067637XX (Active Metabolite)
Tidsramme: 12 weeks after baseline according to protocol
Assessment made on the week 12 visit
12 weeks after baseline according to protocol
Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TT
Tidsramme: 36 weeks according to protocol
Oral clearance of AR-H067637XX in subgroup of patients with genotype TT for gene polymorphism ABCB1 C3435T
36 weeks according to protocol
Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TC
Tidsramme: 36 weeks according to protocol
Oral clearance of AR-H067637XX in subgroup of patients with genotype TC for gene polymorphism ABCB1 C3435T
36 weeks according to protocol
Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype CC
Tidsramme: 36 weeks according to protocol
Oral clearance of AR-H067637XX in subgroup of patients with genotype CC for gene polymorphism ABCB1 C3435T
36 weeks according to protocol

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AstraZeneca

Etterforskere

  • Hovedetterforsker: Gregory Y Lip, Prof, University Department of Medicine, City Hospital, Birmingham, B18 7QH, England, UK

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2007

Primær fullføring (Faktiske)

1. juni 2008

Studiet fullført (Faktiske)

1. juni 2008

Datoer for studieregistrering

Først innsendt

22. mai 2008

Først innsendt som oppfylte QC-kriteriene

23. mai 2008

Først lagt ut (Anslag)

26. mai 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

23. mars 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. mars 2012

Sist bekreftet

1. mars 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • D1250C00008

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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