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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT05112666
Eligibility Criteria:
Inclusion Criteria:
* Be ≥18 years of age at the time of anticoagulation initiation
* Have active cancer and acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE)
* Treated with rivaroxaban (or any DOAC) or LMWH as their first recorded anticoagulant prescription 7 to 30 days post-acute CAT event diagnosis
* Have been active in the data set for at least 12-months prior to the index event and had at least one provider visit in the 12-months prior to the acute VTE event
Exclusion Criteria:
* Evidence of atrial fibrillation, recent hip/knee replacement (with 90 days of CAT), ongoing VTE treatment, valvular heart disease defined as any rheumatic heart disease, mitral stenosis or mitral valve repair/replacement
* History of inferior vena cava filter before cohort entry
* vitamin K antagonist (VKA) use between cohort entry and index day (initiation of DOAC or LMWH)
* Evidence of any type of therapeutic anticoagulation use during all available look-back period per written prescription or patient self-report
* Initiation of rivaroxaban or other DOACs or LMWH during the study period at non-therapeutic doses (e.g., enoxaparin at a dose other than 1 mg/kg twice daily or 1.5 mg/kg once daily; dalteparin at a dose other than 200 IU/kg of total body weight)
* Pregnancy
* Recording indicative of palliative care before cohort entry
* Any clinically-relevant bleeding-related d hospitalization or VTE recurrence between the initial CAT and the start of observation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05112666
Study Brief:
Protocol Section:
NCT05112666