Anticoagulants, Venous Thromboembolism
Conditions
Keywords
Venous thromboembolism, D-Dimer, Apixaban, Extended treatment
Brief summary
The study aims at optimizing the long-term and extended management of patients with a first episode of venous thromboembolism (proximal deep vein thrombosis with or without pulmonary embolism) (VTE). Patients at high risk of recurrence (with altered D-dimer test), who had received anticoagulation (whatever the drug used) for 12-15 months after the first episode of thrombosis, will be treated with Apixaban 2,5 mg x 2 for 18 months as extended treatment. Patients at low risk, with normal D-dimer test, will stop anticoagulation definitely.
Detailed description
This prospective cohort study aims to assess the efficacy and safety of a management procedure to decide on giving or not an extended anticoagulation (administering apixaban 2 2.5 mg twice daily ) to outpatients with a single episode of proximal deep vein thrombosis of the lower limbs and/or pulmonary embolism who had received 12-15 months of anticoagulation (whatever the anticoagulant drug used). The study seeks to assess whether a management procedure involving D-dimer testing assessment can identify a subset of subjects at low risk of recurrence in whom an extended anticoagulation can be safely avoided.
Interventions
DRUGApixaban
Apixaban 2.5 mg x 2 will be administered to patients with positive D-dimer results
Sponsors
Arianna Anticoagulazione Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The patients included in the study will receive a serial determination of D-dimer assay (a maximum of four determinations in case of negative results).The D-dimer measurements should be performed at the moment of patient screening, when patients still assume their anticoagulant treatment (T0), at 15±2 days (T1), 30±4 days (T2), and 60±5 (T3) days after their anticoagulant treatment has been stopped. At the first positive D-dimer result patients resume anticoagulation with apixaban 2.5 mg bis in die for the next 18 months. Patients with negative D-Dimer results at all determinations stop anticoagulation definitely and will followed up for the next 18 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and rate of patients with confirmed recurrent VTE and VTE-related death (efficacy). | From date of enrollment until the date of first documented event assessed up to 18 months | The occurrence of proximal deep vein thrombosis with or without pulmonary embolism (new or recurrent episode) wil be recorded in all patients |
| Number and rate of major Bleeding events (defined according to International Society on Thrombosis and Haemostasis guidelines (safety) | From date of enrollment until the date of first documented event assessed up to18 months | Fatal bleeding; intracranial; intraspinal; intraocular; pericardial; intra-articular; intramuscular with compartment syndrome; retroperitoneal,; acute clinically overt bleeding will be recorded in all patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of and rate of thromboembolic events | From date of enrollment until the date of first documented event assessed up to 18 months | Transient ischemic attack (TIA), Stroke, Myocardial infarction will be recorded in all patients |
| Presence of severe post-thrombotic syndrome according to Villalta Score | 18 months | Patient with deep vein thrombosis as index event will be evaluated, at the and of follow-up, applying Villalta score, commonly used to diagnose post-thrombotic syndrome in the subacute phase of thrombosis. The presence of venous ulcer of the leg or a score \> of 15 points indicate the occurrence of severe post-thrombotic syndrome. The maximum score is 33. The score from 5 to 9 points indicate mild post-thrombotic syndrome and from 10 to 15 points indicate moderate post-thrombotic syndrome |
| Number and rate of non major bleeding complications | From date of enrollment until the date of first documented event assessed up to18 months | In all patients will be recorded any sign or symptom of hemorrhage that does not fit the criteria for the definition of major bleeding but does meet at least one of the following criteria: 1)requiring medical intervention by a healthcare professional; 2) leading to hospitalization or increased level of care;3) prompting a face to face evaluation |
| Number and rate of dead patients (overall mortality) | From date of enrollment until the date of first documented event assessed up to 18 months | VTE-related death; cardiovascular related-death; bleeding-related death; death for: cancer, infectious disease and unknown cause; sudden death will be recorded in all patients |
Countries
Italy
Outcome results
None listed