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Assessment of the Effectiveness and Safety Outcome in Patients With Atrial Fibrillation Treated by Apixaban in Belgium

NCT05116267 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2023-05-17

No results posted yet for this study

Summary

The PROVECT study is a retrospective, multicentre study assessing the effectiveness and the safety outcomes in patients with non-valvular atrial fibrillation (NVAF) treated by apixaban between 2015 and 2019 (5 years follow up). The study will use harmonized and federated hospital electronic health records (EHRs) from 10 Belgian hospitals. Outcomes of interest are major bleeding events leading to hospitalization (safety), stroke and systemic thromboembolic events (effectiveness), and all-cause mortality (as an exploratory endpoint, and after confirming the data availability because the death events are not always recorded into hospital EHRs). The study will analyse the outcomes by patient characteristics including the age groups focusing on elderly, thromboembolism risk factors (CHAR2RDSR2R-VASc score), bleeding risk factors (HAS-BLED score), comorbidities (Deyo-Charlson Comorbidity Index, DCCI) score and frailty.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Belgium

Study Locations

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Entities

Diseases
Companies

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 NCT05116267 on ClinicalTrials.gov