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Apixaban for Extended Anticoagulation (APIDULCIS)

NCT03678506 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2023-02-24

No results posted yet for this study

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.

Conditions

  • Venous Thromboembolism
  • Anticoagulants

Interventions

DRUG

Apixaban

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

Sponsors & Collaborators

  • Arianna Anticoagulazione Foundation

    lead OTHER

Principal Investigators

  • Daniela Poli, MD · Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-16
Primary Completion
2021-09-01
Completion
2023-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03678506 on ClinicalTrials.gov