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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT04510805
Eligibility Criteria:
Inclusion Criteria:
* Scheduled to undergo cardiac surgery with planned warfarin anticoagulation for at least three months.
* Age ≥ 18 and \< 80 years.
* Written informed consent has been obtained.
Exclusion Criteria:
* Allergy to warfarin tablet or excipients.
* Enrollment or planned enrollment in other research that would conflict with full participation in the study or confound the observation or interpretation of the study findings.
* Patients who in the opinion of the recruiting clinician are:
* unwilling or unable to comply with the protocol requirements and/or,
* considered unreliable concerning the requirements for follow-up during the study and/or, compliance with drug administration.
* Patient with life expectancy less than the expected duration of the trial due to concomitant disease.
* Contraindication to warfarin therapy. The following are examples but not an exhaustive list:
* Pregnancy.
* Cerebral infarction or cerebral haemorrhage (from patients' medical record) within the 3 months prior to heart valve replacement
* Severe heart failure (New York Heart Function Class IV)
* Severe renal failure (CLcr (Cockcroft-Gault) ≤20mL / min)
* Severe liver failure (Child-Pugh≥10)
* Abnormal liver function (elevated transaminase more than three times the upper limit of the local hospital clinical laboratory).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04510805
Study Brief:
Protocol Section:
NCT04510805