Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation
20. marts 2012 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1084
Fase
- Fase 2
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
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 1
AZD0837 450 mg
|
ER tablet, PO, once daily for a period of 3-9 months.
ER tablet, PO, twice daily for a period of 3-9 months
|
|
Eksperimentel: 2
AZD0837 200 mg
|
ER tablet, PO, once daily for a period of 3-9 months.
ER tablet, PO, twice daily for a period of 3-9 months
|
|
Eksperimentel: 3
AZD0837 300 mg
|
ER tablet, PO, once daily for a period of 3-9 months.
ER tablet, PO, twice daily for a period of 3-9 months
|
|
Eksperimentel: 4
AZD0837 150 mg
|
ER tablet, PO, once daily for a period of 3-9 months.
ER tablet, PO, twice daily for a period of 3-9 months
|
|
Aktiv komparator: 5
Vitamin-K antagonist at INR 2-3
|
Tablet, PO for a period of 3-9 months.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Gregory Y Lip, Prof, University Department of Medicine, City Hospital, Birmingham, B18 7QH, England, UK
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.
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
1. februar 2007
Primær færdiggørelse (Faktiske)
1. juni 2008
Studieafslutning (Faktiske)
1. juni 2008
Datoer for studieregistrering
Først indsendt
22. maj 2008
Først indsendt, der opfyldte QC-kriterier
23. maj 2008
Først opslået (Skøn)
26. maj 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
23. marts 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. marts 2012
Sidst verificeret
1. marts 2012
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Hjertesygdomme
- Hjerte-kar-sygdomme
- Arytmier, hjerte
- Atrieflimren
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Fibrinmodulerende midler
- Mikronæringsstoffer
- Vitaminer
- Antikoagulanter
- Antifibrinolytiske midler
- Hæmostatika
- Koagulanter
- Vitamin K
- Warfarin
Andre undersøgelses-id-numre
- D1250C00008
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 .