ISRCTN ISRCTN11629138
DOI https://doi.org/10.1186/ISRCTN11629138
EudraCT/CTIS number 2009-016993-34
ClinicalTrials.gov number NCT01119300
Secondary identifying numbers 9031
Submission date
29/10/2010
Registration date
29/10/2010
Last edited
14/07/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Munir Pirmohamed
Scientific

Department of Pharmacology and Therapeutics
Sherrington Building
The New Medical School
Ashton Street
Liverpool
L69 3GE
United Kingdom

Email munirp@liv.ac.uk

Study information

Study designMulticentre randomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymEUPACT
Study objectivesTwo-armed, single blind, randomised controlled trial of genotype guided dosing versus non-genotype guided dosing.
Ethics approval(s)MREC approved (ref: 10/H1005/51)
Health condition(s) or problem(s) studiedTopic: Stroke Research Network; Subtopic: Prevention; Disease: Drug type
InterventionGenotyping for CYP2C9 & VKORC1: Predose POCT to determine genotype for CYP2C9 and VKORC1 for participants randomised in intervention group.

Follow up length: 3 months
Intervention typeOther
Primary outcome measurePercent time within therapeutic INR range 2.0-3.0 during 12 weeks after start of coumarin therapy
Secondary outcome measuresNot provided at time of registration
Overall study start date04/10/2010
Completion date22/06/2013

Eligibility

Participant type(s)Patient
Age groupNot Specified
Lower age limit18 Years
SexNot Specified
Target number of participantsPlanned sample size: 706; UK sample size: 706
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment04/10/2010
Date of final enrolment22/06/2013

Locations

Countries of recruitment

  • England
  • Sweden
  • United Kingdom

Study participating centre

Department of Pharmacology and Therapeutics
Liverpool
L69 3GE
United Kingdom

Sponsor information

University of Liverpool (UK)
University/education

Department of Pharmacology and Therapeutics
Sherrington Building
The New Medical School
Ashton Street
Liverpool
L69 3GE
England
United Kingdom

Website http://www.liv.ac.uk/
ROR logo "ROR" https://ror.org/04xs57h96

Funders

Funder type

Government

European Union (EU) (Belgium) - Seventh Framework Programme (FP7)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 12/12/2013 Yes No
HRA research summary 28/06/2023 No No