Contact information
Type
Scientific
Primary contact
Prof Munir Pirmohamed
ORCID ID
Contact details
Department of Pharmacology and Therapeutics
Sherrington Building
The New Medical School
Ashton Street
Liverpool
L69 3GE
United Kingdom
munirp@liv.ac.uk
Additional identifiers
EudraCT number
2009-016993-34
ClinicalTrials.gov number
NCT01119300
Protocol/serial number
9031
Study information
Scientific title
Acronym
EUPACT
Study hypothesis
Two-armed, single blind, randomised controlled trial of genotype guided dosing versus non-genotype guided dosing.
Ethics approval
MREC approved (ref: 10/H1005/51)
Study design
Multicentre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Topic: Stroke Research Network; Subtopic: Prevention; Disease: Drug type
Intervention
Genotyping for CYP2C9 & VKORC1: Predose POCT to determine genotype for CYP2C9 and VKORC1 for participants randomised in intervention group.
Follow up length: 3 months
Intervention type
Other
Phase
Phase IV
Drug names
Primary outcome measures
Percent time within therapeutic INR range 2.0-3.0 during 12 weeks after start of coumarin therapy
Secondary outcome measures
Not provided at time of registration
Overall trial start date
04/10/2010
Overall trial end date
22/06/2013
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Planned sample size: 706; UK sample size: 706
Participant exclusion criteria
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
Recruitment start date
04/10/2010
Recruitment end date
22/06/2013
Locations
Countries of recruitment
Sweden, United Kingdom
Trial participating centre
Department of Pharmacology and Therapeutics
Liverpool
L69 3GE
United Kingdom
Sponsor information
Organisation
University of Liverpool (UK)
Sponsor details
Department of Pharmacology and Therapeutics
Sherrington Building
The New Medical School
Ashton Street
Liverpool
L69 3GE
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
European Union (EU) (Belgium) - Seventh Framework Programme (FP7)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24251363
Publication citations
-
Results
Pirmohamed M, Burnside G, Eriksson N, Jorgensen AL, Toh CH, Nicholson T, Kesteven P, Christersson C, Wahlström B, Stafberg C, Zhang JE, Leathart JB, Kohnke H, Maitland-van der Zee AH, Williamson PR, Daly AK, Avery P, Kamali F, Wadelius M, , A randomized trial of genotype-guided dosing of warfarin., N. Engl. J. Med., 2013, 369, 24, 2294-2303, doi: 10.1056/NEJMoa1311386.