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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT06149520
Eligibility Criteria:
Inclusion Criteria:
* Male and female (if postmenopausal or hysterectomized) aged 18 years or older
* Acute symptomatic proximal deep vein thrombosis (DVT) documented by compression ultrasound (CUS) and all of the following:
* duration of symptoms 14 days or less
* Proximal DVT involving at least 1 of the following proximal veins: the popliteal vein, the femoral vein, the common femoral vein and the external iliac vein
* adequate visualization of the most proximal end of the thrombus
* receiving therapeutic dose anticoagulation with low molecular weight heparins (LMWHs) and/or direct oral anticoagulants (DOACs) according to the respective product labels
* Measured body weight within 50 to 130 kg
* Signed informed consent
Exclusion Criteria:
* Acute symptomatic pulmonary embolism (PE) requiring systemic or catheter-directed thrombolytic therapy, catheter-directed mechanical thrombectomy, or surgical embolectomy
* Active bleeding or high risk for bleeding (at the discretion of the investigator)
* Recent (\<3 months) ischemic stroke, myocardial infarction, intracranial hemorrhage, or major surgery or severe trauma (at the discretion of the investigator)
* Active cancer, i.e., locally active, regionally invasive or metastatic and/or anticancer therapy within the last 6 months, except basal cell or squamous cell carcinoma
* Therapeutic-dose anticoagulants for \> 72 hours before randomization, or current use of vitamin K antagonists
* Planned or current use of the following medications:
* Any antiplatelet therapy, except acetylsalicylic acid (ASA) ≤100 mg/day
* Antifibrinolytic drugs
* Therapeutic antibodies
* Male participants with women of childbearing potential (WOCBP) partners unwilling to use highly effective contraception from start of study intervention until end of study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06149520
Study Brief:
Protocol Section:
NCT06149520