Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-24 @ 1:00 PM
NCT ID:
NCT01119261
Eligibility Criteria:
Inclusion Criteria:
* 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 and Greece and INR 2.5-3.5 in the Netherlands)
* Age ≥ 18 years
* Ability to attend scheduled visits
* Signed informed consent
Exclusion Criteria:
* Presence of a mechanical heart valve
* Severe cognitive impairment
* Known genotype CYP2C9 or VKORC1 at start of the study
* Previous or current treatment with any coumarin
* Pregnancy or lactation
* Non-eligible subject
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01119261
Study Brief:
Protocol Section:
NCT01119261