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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT04748393
Eligibility Criteria:
Inclusion Criteria:
1. Ability of subject to understand the character and individual consequences of this clinical study;
2. Signed and dated informed consent of the subject available before the start of any specific study procedures;
3. Age ≥18 years and ≤ 50 years;
4. Confirmed symptomatic first or recurrent VTE;
1. DVT: incompressibility of proximal or distal veins of the affected leg by compression ultrasonography or venous filling defect on multi-detector computed tomography venography. The diagnosis of ipsilateral recurrent DVT is defined as a CUS that shows incompressibility of a different venous segment than at the reference CUS examination, or in case of a pronounced increase in vein diameter (≥4 mm) of a previous non-compressible venous segment, or by an abnormal signal of Magnetic resonance direct thrombus imaging (MRDTI);
2. PE: both first and recurrent PE are diagnosed in case of at least one filling defect in the pulmonary artery tree on multi-detector computed tomography pulmonary angiography (CTPA) up to the subsegmental level, or high probability result of ventilation perfusion scintigraphy;
5. Childbearing potential, i.e. with active menstrual cycle with or without hormonal regulation of any kind initiated for reasons of either contraception or for treatment of abnormal menstrual bleeding;
6. Inclusion before the first day of next menstrual cycle after VTE diagnosis or within 1 month after the VTE diagnosis, whichever comes first.
Exclusion Criteria:
1. Woman between the ages of 18 and 50 who were subjected to hysterectomy or chemically induced menopause;
2. Woman between the ages of 18 and 50 with premature menopause (established before study inclusion);
3. Planned treatment with parenteral anticoagulation (and no switch to oral drugs);
4. Medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than 6 months, or unwillingness to sign informed consent;
5. Non-compliance or inability to adhere to the follow-up visits;
6. Pregnancy or post-partum (first three months) associated VTE;
7. Active in vitro fertilization (IVF) treatment or planned IVF treatment during the study period.
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04748393
Study Brief:
Protocol Section:
NCT04748393