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ISRCTN
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ISRCTN11629138
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ClinicalTrials.gov identifier
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NCT01119300
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Public title
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European Pharmacogenetics of Anticoagulant Therapy
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Scientific title
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Acronym
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EUPACT
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Serial number at source
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9031
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Study hypothesis
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Two-armed, single blind, randomised controlled trial of genotype guided dosing versus non-genotype guided dosing.
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Lay summary
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Ethics approval
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MREC approved (ref: 10/H1005/51)
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Study design
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Multicentre randomised interventional treatment trial
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Countries of recruitment
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United Kingdom, International
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Disease/condition/study domain
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Topic: Stroke Research Network; Subtopic: Prevention; Disease: Drug type
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Participants - inclusion criteria
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1. Patients with either venous thromboembolism (VTE) or atrial fibrillation (AF) requiring coumarin therapy for at least 12 weeks and a target International Normalised Ratio (INR) in the low intensity range (INR range 2 - 3)
2. Aged greater than or equal to 18 years, either sex
3. Ability to attend scheduled visits
4. Signed informed consent
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Participants - exclusion criteria
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1. Presence of a mechanical heart valve
2. Severe cognitive impairment which affects adherence to therapy as judged by the responsible physician
3. Known genotype CYP2C9 or VKORC1 at start of the study
4. Previous or current treatment with any coumarin (maximum one dose allowed)
5. Pregnancy or lactation
6. Non-eligible subject according to the treating physician
7. A blood transfusion within the last two weeks or bone marrow transplantation at any time
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Anticipated start date
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04/10/2010
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Anticipated end date
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22/06/2013
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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Planned sample size: 706; UK sample size: 706
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Interventions
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Genotyping for CYP2C9 & VKORC1: Predose POCT to determine genotype for CYP2C9 and VKORC1 for participants randomised in intervention group.
Follow up length: 3 months
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Primary outcome measure(s)
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Percent time within therapeutic INR range 2.0-3.0 during 12 weeks after start of coumarin therapy
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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European Union (EU) (Belgium) - Seventh Framework Programme (FP7)
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Trial website
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Publications
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Contact name
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Prof
Munir
Pirmohamed
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Address
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Department of Pharmacology and Therapeutics
Sherrington Building
The New Medical School
Ashton Street
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City/town
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Liverpool
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Zip/Postcode
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L69 3GE
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Country
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United Kingdom
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Email
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munirp@liv.ac.uk
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Sponsor
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University of Liverpool (UK)
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Address
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Department of Pharmacology and Therapeutics
Sherrington Building
The New Medical School
Ashton Street
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City/town
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Liverpool
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Zip/Postcode
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L69 3GE
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Country
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United Kingdom
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Sponsor website:
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http://www.liv.ac.uk/
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Date applied
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29/10/2010
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Last edited
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29/10/2010
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Date ISRCTN assigned
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29/10/2010
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