- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00377143
PRospective Evaluation Comparing Initiation of Warfarin StrategiEs (PRECISE): Pharmacogenetic-guided Versus Usual Care
14 februari 2012 uppdaterad av: University of Florida
Warfarin (also called Coumadin®) is an anticoagulant drug (blood thinner) given to patients to help prevent blood clots from forming or to help prevent the growth of an existing blood clot.
The purpose of this study is to collect information on a possible method used to determine the best warfarin dose for people before they start warfarin.
This study will focus on finding out if a person's stable dose can be better predicted by using a new approach (called "pharmacogenetic-guided dosing") compared to the current warfarin dosing method.
The pharmacogenetic-guided dosing method (the new warfarin dosing method) will use a person's specific health and genetic information to calculate a patient's warfarin dose at the beginning of warfarin treatment.
The hope is that through this research, we may someday be able to use an individual's genetic information to guide the selection of their specific warfarin dose at the beginning of treatment, leading to precise warfarin dosing and less need for the current trial and error process.
Studieöversikt
Status
Indragen
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Warfarin is the mainstay of therapy in preventing venous thromboembolism (VTE), pulmonary embolism (PE), and subsequent morbidity and mortality.
Despite its proven efficacy in reducing the advent of clot formation, patient-specific warfarin dosing is difficult to predict, with the initial dose regimen often resulting in supra- and subtherapeutic anticoagulation, and subsequently increasing patients' risk of bleeding or embolism.
It has been shown that interpatient warfarin dosing variability is due in part to genetic variations found in the cytochrome P450 2C9 metabolism pathway (CYP2C9), as well as proteins involved in the coagulation cascade, most importantly vitamin K epoxide reductase complex subunit 1 (VKORC1).
A recent retrospective study has shown that these two genes in addition to several clinical/demographic factors account for greater than 58% of the variation in patient-specific warfarin doses.
However, there have been no studies documenting prospective use of this information in selecting an initial warfarin dose.
Hypothesis: Stable therapeutic management of warfarin therapy can be more precisely achieved when patients are prospectively dosed based on a pharmacogenetic-guided dosing equation compared to usual care.
Aim a: To determine if pharmacogenetic-guided dosing of warfarin is superior to usual care, when defined as the accuracy of the initial versus the stable warfarin dose.
This will be assessed as the mean absolute difference in initial versus stable dose.
Aim b: To determine if a stable warfarin dose is more quickly achieved using the pharmacogenetic-guided dosing equation compared to usual care.
This will be assessed as time to stable dose.
Aim c: To determine if pharmacogenetic-guided dosing is superior to usual care in terms of overdosing and underdosing patients.
This will be assessed as the fraction of the population overdosed and the fraction of population underdosed by the two methods.
We propose to evaluate a pharmacogenetic-guided dosing approach compared to usual care in the initiation of warfarin management.
The selected pharmacogenetic-guided equation is a validated equation that includes both genetic and clinical factors and is relatively easy to incorporate into current clinical practice.
Patients newly initiating warfarin therapy in a hospital setting will be randomized to receive either pharmacogenetic-guided or usual care, with follow-up anticoagulation management services provided by the University of Florida Health System Anticoagulation Clinic.
Prospectively determining patients' stable dose has important clinical implications in today's management of warfarin therapy.
Being able to predetermine a patient's stable dose upon initiation of therapy has the potential to decrease the time spent in supra- and subtherapeutic anticoagulation and reduce the number of clinic visits required to achieve a stable dose.
Therefore we propose this study to test if using genotype data in determining the initial warfarin dose is more effective than usual care in predicting stable dose.
If we can document the value of such an approach, this will provide the level of evidence needed to translate pharmacogenetic-guided dosing of warfarin into clinical practice.
Studietyp
Interventionell
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Florida
-
Gainesville, Florida, Förenta staterna, 32610
- Shands at the University of Florida
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Newly initiating warfarin
Exclusion Criteria:
- Previous use of warfarin
- Cancer
- Hepatic Disease
- History of alcoholism
- Diarrheal illness
- Febrile Illness
- Blood dyscrasias
- Pregnancy
- Medical plan to hold warfarin administration before stable dose is achieved (ie. for surgical intervention)
- Dementia
- Active bleed
- Aneurysm
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vad mäter studien?
Primära resultatmått
Resultatmått |
---|
Accuracy of the initial versus the stable warfarin dose, measured as mean absolute difference in initial versus stable dose
|
Sekundära resultatmått
Resultatmått |
---|
Time to stable dose
|
The frequency of subtherapeutic and supratherapeutic international normalized ratio (INR) measurements
|
The fraction of population overdosed and underdosed at warfarin initiation
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Julie A Johnson, Pharm.D., University of Florida
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2006
Primärt slutförande (Faktisk)
1 augusti 2006
Studieregistreringsdatum
Först inskickad
13 september 2006
Först inskickad som uppfyllde QC-kriterierna
13 september 2006
Första postat (Uppskatta)
15 september 2006
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
16 februari 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 februari 2012
Senast verifierad
1 september 2011
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 131-2006
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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