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 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT02829957
Eligibility Criteria:
Inclusion Criteria:
* Non-pregnant women, age 18-50
* For study purposes, evidence of negative pregnancy is accounted for by the treating physician's initiation of treatment with oral anticoagulants
* Objectively diagnosed VTE or atrial fibrillation/flutter
* Patient reported active menstruation - does not apply to women who were recently pregnant
* Clinical plan and patient agreement to treat with oral anticoagulation for 3 months or longer
* Patients must have a working telephone
Exclusion Criteria:
* Package insert exclusions for Eliquis (Apixban) or Xarelto (Rivaroxaban): \[active pathological bleeding or severe hypersensitivity reaction to XARELTO or ELIQUIS (e.g., anaphylactic reactions)\]
* Plan to become pregnant in the next three months.
* Concomitant prescribed use of aspirin or thienopyridenes or other platelet inhibiting drugs
* Plan for surgical hysterectomy or endometrial ablation
* Known uterine cancer
* Von Willebrand's disease, or hemophilia
* Known coagulopathy from liver disease
* Conditions likely to preclude adherence to study procedures: Active intravenous drug use, known alcoholism, homelessness, or uncontrolled psychiatric illness.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02829957
Study Brief:
Protocol Section:
NCT02829957