EUropean Pharmacogenetics of AntiCoagulation Therapy trial - EU-PACT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-016994-13-NL

Enrollment

985

Registered

2009-12-16

Start date

2010-03-19

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly diagnosed patients with venous tromboembolism (VTE) or atrial fibrillation (AF) requiring oral anticoagulation with phenprocoumon. MedDRA version: 12.0 Level: LLT Classification code 10003658 Term: Atrial fibrillation MedDRA version: 12.0 Level: LLT Classification code 10012107 Term: Deep venous thrombosis NOS MedDRA version: 12.0 Level: LLT Classification code 10037377 Term: Pulmonary embolism

Interventions

Trade Name: phenprocoumon (various trade names) Pharmaceutical Form: Tablet INN or Proposed INN: PHENPROCOUMON CAS Number: 435972 Concentration unit: mg milligram(s) Concentration type: equal Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with either venous thromboembolism (VTE) or atrial fibrillation (AF) requiring coumarin therapy for at least 12 weeks and a target INR in the low intensity range (INR range 2-3 in the United Kingdom, Sweden, Germany, Austria, Greece and Spain and INR 2.5-3.5 in the Netherlands) 2. Age = 18 years 3. Ability to attend scheduled visits 4. Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Abnormal clotting function at baseline (at least one of): a. INR >1.5 b. platelet count 1.3 times the upper reference value that is not explained by presence of lupus anticoagulants 2. Presence of a mechanical heart valve 3. Severe cognitive impairment 4. Known genotype CYP2C9 or VKORC1 at start of the study 5. Previous or current treatment with any coumarin 6. Pregnancy or lactation 7. Non-eligible subject, e.g. fysical or mental health problems.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): The percent time within therapeutic INR range 2-3 during 12 weeks following the initiation of coumarin therapy.;Main Objective: The primary endpoint is the percent time within therapeutic INR range 2-3 during 12 weeks following the initiation of coumarin therapy. Our hypothesis is that pharmacogenetic guided dosing will increse the time within INR range if compared to non-pharmacogenetic guided dosing.;Secondary Objective: 1. Time to and number of patients with INR more than 4.0 2. % time spent above INR 4.0. 3. % time spent below INR 1.5, which indicates under-anticoagulation. 4. Time to reach therapeutic INR 5. Time to reach stable dose 6. Time to and number of bleeding events 7. Time to and number of thromboembolic events 8. The incidence of coumarin sensitivity 9. The incidence of coumarin resistance 10. Number of coumarin dose adjustments. 11. The clinical utility of the rapid genotyping test developed by LGC. 12. Quality of life (EQ-5D) 13. The cost-effectiveness of genotype-guided dosing for each coumarin compared with non-genotype-guided dosing.	—

Measure

Time frame

Primary end point(s): The percent time within therapeutic INR range 2-3 during 12 weeks following the initiation of coumarin therapy.;Main Objective: The primary endpoint is the percent time within therapeutic INR range 2-3 during 12 weeks following the initiation of coumarin therapy. Our hypothesis is that pharmacogenetic guided dosing will increse the time within INR range if compared to non-pharmacogenetic guided dosing.;Secondary Objective: 1. Time to and number of patients with INR more than 4.0 2. % time spent above INR 4.0. 3. % time spent below INR 1.5, which indicates under-anticoagulation. 4. Time to reach therapeutic INR 5. Time to reach stable dose 6. Time to and number of bleeding events 7. Time to and number of thromboembolic events 8. The incidence of coumarin sensitivity 9. The incidence of coumarin resistance 10. Number of coumarin dose adjustments. 11. The clinical utility of the rapid genotyping test developed by LGC. 12. Quality of life (EQ-5D) 13. The cost-effectiveness of genotype-guided dosing for each coumarin compared with non-genotype-guided dosing.

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Countries

Austria, Germany, Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026