European Pharmacogenetics of Anticoagulant Therapy

ISRCTN	ISRCTN11629138
DOI	https://doi.org/10.1186/ISRCTN11629138
ClinicalTrials.gov (NCT)	NCT01119300
Clinical Trials Information System (CTIS)	2009-016993-34
Protocol serial number	9031
Sponsor	University of Liverpool (UK)
Funder	European Union (EU) (Belgium) - Seventh Framework Programme (FP7)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Multicentre randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	EUPACT
Study objectives	Two-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) studied	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
Primary outcome measure(s)	Percent time within therapeutic INR range 2.0-3.0 during 12 weeks after start of coumarin therapy
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	22/06/2013

Participant type(s)	Patient
Age group	Not Specified
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	706
Key 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
Key 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
Date of first enrolment	04/10/2010
Date of final enrolment	22/06/2013

Department of Pharmacology and Therapeutics

Liverpool
L69 3GE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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