Apixaban for Extended Anticoagulation (APIDULCIS)

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arianna Anticoagulazione Foundation
• Treatments: Apixaban; Fibrin fragment D

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