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Completed

NCT Number: NCT03413176

Evaluation of Reporting of Vascular Endothelial Growth Factor and Vascular Endothelial Growth Factor Receptor Inhibitors Associated Cardiovascular Adverse reactioN.

Antiangiogenics (AAs) which are vascular endothelial growth factor (VEGF) or VEGF receptor (VEGFR) inhibitors might have high grade adverse events (AEs) on the cardio-vascular system. This study investigates reports of cardio-vascular toxicity with treatment including VEGF and VEGFR inhibitors using the World Health Organization (WHO) database VigiBase.

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Key information

Conditions

Cardiac Complication Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.

Paris, 75013, France

About this study

AAs have dramatically improved clinical outcomes in multiple cancer types and are increasingly being tested in earlier disease settings and used in combination. However, AEs can occur. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to identify cases of cardiovascular adverse drug reaction following treatment with AAs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
  • Adverse event reported were including the MedDRA terms: Cardiac disorders (SOC), Vascular disorders (SOC), Sudden death (PT)
  • Patients treated with antiangiogenics included in the following list:

Exclusion criteria

  • Chronology not compatible between the drug and the toxicity

Treatment and study plan

Cardiac complication induced by VEGF/VEGFR inhibitor

Drug

Case reported in the World Health Organization (WHO) of cardiac complication of patient treated by AAs, with a chronology compatible with the drug toxicity

Primary outcomes

  1. Cardio-vascular toxicity of AAs

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018

    Identification and report of the cardio-vascular toxicity of AAs. The research includes the report with MedDRA terms: SOC Cardiac Disorders, SOC Vascular Disorders, Sudden death (PT). Drugs investigated are: sorafenib, sunitinib, pazopanib, vandetanib, axitinib, regorafenib, nintedanib, lenvatinib, ceritinib, bevacizumab, ramucirumab, aflibercept.

Secondary outcomes

  1. Causality assessment of reported cardiovascular events according to the WHO system

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018

  2. Description of the type of cardiotoxicity depending on the category of AAs

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018

  3. Description of the duration of treatment when the toxicity happens (role of cumulative dose)

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018

  4. Description of the drug-drug interactions associated with adverse events

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018

  5. Description of the pathologies (cancer) for which the incriminated drugs have been prescribed

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018

  6. Description of the population of patients having a cardio-vascular adverse event

    Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Registry information

Official study title

Evaluation of Reporting of VEGF Inhibitors Associated Cardiovasclular Adverse reactioNs Using International Pharmacovigilance Database.

Acronym: VEGAN

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 29, 2018
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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