NL-OMON32579CompletedNot Applicable
EUropean Pharmacogenetics of AntiCoagulation Therapy trial - EU-PACT
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- niversiteit Utrecht
- Enrollment
- 595
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1. Patients with either venous thromboembolism (VTE) or atrial fibrillation (AF) requiring treatment with acenocoumarol 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
Exclusion Criteria
- •1. Abnormal clotting function at baseline (at least one of):
- •a. INR >1.5
- •b. platelet count <100 x 10^9 per Liter blood
- •c. prolonged APTT >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.
Investigators
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