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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT02935751
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age
* On long term anticoagulation with apixaban for treatment of non-valvular atrial fibrillation or venous thromboembolism
* Undergoing elective major surgery or invasive procedure
Exclusion Criteria:
* Inability to obtain informed consent for the blood sample draws
* Any condition precluding collection of follow-up information
* Participation in another clinical trial
* Apixaban Package Insert Recommendations and Cautions
* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
* Women must not be breastfeeding
* WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug apixaban plus 5 half-lives of study drug apixaban (approximately 3 days) plus 30 days (duration of ovulatory cycle) for a total of 33 days post- treatment completion.
* Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug apixaban plus 5 half-lives of the study drug (approximately 3 days) plus 90 days (duration of sperm turnover) for a total of 93 days post-treatment completion.
* Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However WOCBP must still undergo pregnancy testing as described.
* The safety and efficacy of apixaban have not been studied in patients with prosthetic heart valves. Therefore, use is not recommended in these patients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02935751
Study Brief:
Protocol Section:
NCT02935751