Condition category
Circulatory System
Date applied
29/10/2010
Date assigned
29/10/2010
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.liv.ac.uk/

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

  1. 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.

Additional files

Editorial Notes