APIDULCIS: Extended anticoagulation treatment with low-dose apixaban in patients with a first venous thromboembolism and a positive d-dimer, who were treated with standard course of anticoagulatio

Phase 1

• Conditions: a first episode of proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE); MedDRA version: 21.0Level: PTClassification code 10037377Term: Pulmonary embolismSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 21.1Level: PTClassification code 10051055Term: Deep vein thrombosisSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-002340-32-IT
• Lead Sponsor: FONDAZIONE ARIANNA ANTICOAGULAZIONE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-04
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

- outpatients with a single episode of venous thromboembolism (VTE), at a first episode of proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE),
- unprovoked VTE or associated with weak risk factors for thrombosis
- Age older than 18 or younger than 75 years
- Capacity to give written informed consent
- Males and females of any ethnic group
- 12 months of previous anticoagulant therapy (with any anticoagulant drug)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

Exclusion Criteria

1) Events usually associated with low risk of recurrence

•DVT/PE occurred within 3 months from major surgery or major trauma
•Isolated Distal DVT (thrombosis of calf veins)
2) Events associated with a very high risk of recurrence or occurrence of life-threatening recurrent events
•PE episode with shock or life-threatening
•Isolated PE with a systolic pulmonary artery pressure > 60 mmHg at presentation
•DVT/PE associated with active cancer, antiphospholipid syndrome or long-standing medical illnesses
•More than one idiopathic event
3) Index VTE events not included in the study
•All VTE events that occurred in different sites than deep veins of the lower limbs or pulmonary arteries

•Age younger than 18 or older than 75 years
•More documented unprovoked VTE 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 LMWH
•Presence of overt, active chronic diseases (i.e. inflammatory bowel disease)
•Known serious thrombophilic alterations:
•Any absolute contraindication to anticoagulant therapy
•Any contraindication to apixaban (as per local SmPC)
•Presence of antiphospolipid syndrome
•Presence of cava filter
•Concomitant conditions (such as atrial fibrillation) requiring indefinite anticoagulation
•Severe cardio-respiratory insufficiency (NYHA 3 or 4)
•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
Concomitant enrollment in other non observational study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The study seeks to assess whether a management procedure involving D-dimer testing assessment can identify a subset of subjects at high risk of recurrence in whom an extended anticoagulation (administering apixaban 2.5 mg BID) should be done. ;Secondary Objective: In addition, whether the same management procedure can identify a subset of subjects at low risk of recurrence in whom an extended anticoagulation can be safely avoided;Primary end point(s): 1)Primary efficacy end-point: the composite of confirmed recurrent VTE and VTE-related death occurring during follow-up in all included patients 2)Primary safety end-point: major bleeding complications occurring during the follow-up period in all included patients;Timepoint(s) of evaluation of this end point: The assessment of the endpoints will be carried out during follow up in all patients and for the entire duration of the study (36 months)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Efficacy:<br>other thromboembolic events, (severe) post-thrombotic syndrome (at the end of follow-up period patients with DVT as index event should receive a final evaluation of the Villalta score; 2)Secondary safety end-points: <br>clinically relevant non major bleeding complications; overall mortality;Timepoint(s) of evaluation of this end point: The assessment of the endpoints will be carried out during follow up in all patients and for the entire duration of the study (36 months); The assessment of the endpoints will be carried out during follow up in all patients and for the entire duration of the study (36 months)