Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03413176
Recruitment Status : Completed
First Posted : January 29, 2018
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment
Cardiac Complication Vascular Diseases Drug: Cardiac complication induced by VEGF/VEGFR inhibitor

Detailed Description:
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.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 150000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Days
Official Title: Evaluation of Reporting of VEGF Inhibitors Associated Cardiovasclular Adverse reactioNs Using International Pharmacovigilance Database.
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : January 15, 2018
Actual Study Completion Date : January 31, 2018
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Drug: Cardiac complication induced by VEGF/VEGFR inhibitor
    Case reported in the World Health Organization (WHO) of cardiac complication of patient treated by AAs, with a chronology compatible with the drug toxicity

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with an AA for a cancer
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413176


Locations
Layout table for location information
France
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.
Paris, France, 75013
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: Joe Elie Salem, MD, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT03413176    
Other Study ID Numbers: CIC1421-18-02
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere:
VEGFR
VEGF
antiangiogenics
angiogenesis
Additional relevant MeSH terms:
Layout table for MeSH terms
Vascular Diseases
Cardiovascular Diseases