European Pharmacogenetics of Anticoagulant Therapy
ISRCTN | ISRCTN11629138 |
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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
Scientific
Department of Pharmacology and Therapeutics
Sherrington Building
The New Medical School
Ashton Street
Liverpool
L69 3GE
United Kingdom
munirp@liv.ac.uk |
Study information
Study design | Multicentre randomised interventional treatment trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 | 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 study start date | 04/10/2010 |
Completion date | 22/06/2013 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Not Specified |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | Planned sample size: 706; UK sample size: 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 |
Locations
Countries of recruitment
- England
- Sweden
- United Kingdom
Study participating centre
Department of Pharmacology and Therapeutics
Liverpool
L69 3GE
United Kingdom
L69 3GE
United Kingdom
Sponsor information
University of Liverpool (UK)
University/education
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/ |
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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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |