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:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
NCT ID:
NCT03678506
Eligibility Criteria:
Inclusion Criteria:
* First unprovoked Venous Thromboembolic Event
* Venous Thromboembolic events associated with one or more risk factors that are no longer present
* Age older than 18 or younger than 75 years
* Capacity to give written informed consent
Exclusion Criteria:
* A) Exclusion criteria regarding the index event
* Events usually associated with low risk of recurrence
* Deep vein thrombosis/ Pulmonary embolism occurred within 3 months from major surgery or major trauma
* Isolated Distal deep vein thrombosis (thrombosis of calf veins)
* Events associated with a very high risk of recurrence or occurrence of life-threatening recurrent events
* Pulmonary Embolism episode with shock or life-threatening
* Isolated pulmonary embolism with a systolic pulmonary artery pressure \> 60 mmHg at presentation
* Deep vein thrombosis/ Pulmonary embolism associated with active cancer, antiphospholipid syndrome or long-standing medical illnesses
* More than one idiopathic event
* Index venous thromboembolic event in different sites than deep veins of the lower limbs or pulmonary arteries
B) Exclusion criteria present at the moment of patients' screening:
* Age younger than 18 or older than 75 years
* More documented unprovoked venous thromboembolic episodes
* Pregnancy or puerperium
* Severe post-thrombotic syndrome (≥ 15 points at the Villalta score)
* Solid neoplasia or blood disease in active phase or requiring chemotherapy/radiotherapy
* All the clinical conditions requiring prolonged treatment with Low Molecular Weight Heparin
* Presence of overt, active chronic diseases (i.e. inflammatory bowel disease)
* Known serious thrombophilic alterations:
* deficiencies of natural anticoagulants (Antithrombin, Protein C, Protein S)
* homozygosity for Factor V Leiden or Factor II G20210A mutations
* double heterozygosity
* Presence of antiphospholipid syndrome
* Presence of vein cava filter
* Concomitant conditions (such as atrial fibrillation) requiring indefinite anticoagulation
* Severe cardio-respiratory insufficiency (NYHA 3 or 4)
* Any absolute contraindications to anticoagulation treatment
* Any other contraindications to Apixaban as per local SmPC
* Life expectancy shorter than 1 year
* Refuse interruption of anticoagulation to perform serial D-dimer assessment
* Geographically inaccessible location
* Inability or refusal to give consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03678506
Study Brief:
Protocol Section:
NCT03678506