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:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT00990158
Eligibility Criteria:
Inclusion Criteria:
* Warfarin therapy administered to a target INR of 2.0 to 3.0
Exclusion Criteria:
* Out of range INR on day of screening - enrolment will only occur if the patient's INR on the day of screening is between 1.8 and 3.4 (inclusive) - if the INR is outside this range the patient will be re-screened when the INR is within this range.
* Recent warfarin initiation - all patients must have received warfarin for a minimum of 3 months
* Planned termination or extended temporary interruption of warfarin within 6 months or anticipated survival of less than 6 months
* Known severe liver disease, known excess alcohol consumption , known malabsorption syndrome or inability to take oral medications
* Use of medications known to interfere with warfarin and whose dose is likely to change over the course of the study (e.g. barbiturates, rifampin etc.)
* Known allergy to vitamin K
* Inability or unwillingness to follow study procedures or provide consent
* Prior participation in this study, or participating in a competing study which may impact INR control
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00990158
Study Brief:
Protocol Section:
NCT00990158