Apixaban for Extended Anticoagulation (APIDULCIS)

  • STATUS
    Recruiting
  • End date
    Jan 27, 2023
  • participants needed
    1200
  • sponsor
    Arianna Anticoagulazione Foundation
Updated on 27 March 2021
thrombosis
clot
d-dimer
venous thromboembolism
deep vein thrombosis
apixaban
pulmonary embolism
anticoagulation therapy
apixaban 2.5 mg

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.

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.

Details
Condition Venous Thromboembolism, Anticoagulants, Thromboembolism, anticoagulant, blood thinner, agents, anticoagulant, anticoagulation agents, blood thinners, anticoagulant drugs
Treatment Apixaban
Clinical Study IdentifierNCT03678506
SponsorArianna Anticoagulazione Foundation
Last Modified on27 March 2021

Eligibility

Yes No Not Sure

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
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