NCT03678506

Apixaban for Extended Anticoagulation (APIDULCIS)

APIDULCIS: Extended Anticoagulation With Low-dose Apixaban After a Standard Course Anticoagulation in Patients With a First Venous Thromboembolism Who Have Positive D-dimer

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: Arianna Anticoagulazione Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Thromboembolism
• Anticoagulants

Interventions

Type	Name	Description
DRUG	Apixaban	Apixaban 2.5 mg x 2 will be administered to patients with positive D-dimer results

Timeline

• Start date: 2018-08-16
• Primary completion: 2021-09-01
• Completion: 2023-01-31
• First posted: 2018-09-19
• Last updated: 2023-02-24

Locations

1 site across 1 country: Italy