Cardiac ComplicationVEGANNCT03413176
Evaluation of Reporting of Vascular Endothelial Growth Factor and Vascular Endothelial Growth Factor Receptor Inhibitors Associated Cardiovascular Adverse reactioN.
An observational study of Cardiac Complication and Vascular Diseases, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Complication, Vascular Diseases
- What is being tested?
- Cardiac complication induced by VEGF/VEGFR inhibitor
- How many people
- 150,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 31 Jan 2018
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with an AA for a cancer
Who may be able to join
- 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:
Who cannot join
- Chronology not compatible between the drug and the toxicity
Trial locations and contacts
1 site in 1 country.
France1 site
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.
Paris, 75013
About this study
Official title: Evaluation of Reporting of VEGF Inhibitors Associated Cardiovasclular Adverse reactioNs Using International Pharmacovigilance Database.
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.
Read the 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.
- Conditions
- Cardiac Complication, Vascular Diseases
- Being tested
- Cardiac complication induced by VEGF/VEGFR inhibitor
- Keywords
- VEGFR, VEGF, antiangiogenics, angiogenesis
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac complication induced by VEGF/VEGFR inhibitorDrug
Case reported in the World Health Organization (WHO) of cardiac complication of patient treated by AAs, with a chronology compatible with the drug toxicity
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardio-vascular toxicity of AAs
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.
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
Secondary outcomes (6)
Causality assessment of reported cardiovascular events according to the WHO system
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
Description of the type of cardiotoxicity depending on the category of AAs
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
Description of the duration of treatment when the toxicity happens (role of cumulative dose)
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
Description of the drug-drug interactions associated with adverse events
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
Description of the population of patients having a cardio-vascular adverse event
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start1 Jan 2018
- Primary completion15 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150,000 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413176
- Sponsor's protocol ID
- CIC1421-18-02
- Acronym
- VEGAN
- Status last verified
- Sep 2019
- First submitted
- 22 Jan 2018
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alexandre J, Moslehi JJ, Bersell KR, Funck-Brentano C, Roden DM, Salem JE. Anticancer drug-induced cardiac rhythm disorders: Current knowledge and basic underlying mechanisms. Pharmacol Ther. 2018 Sep;189:89-103. doi: 10.1016/j.pharmthera.2018.04.009. Epub 2018 Apr 24.
PubMed 29698683Gougis P, Wassermann J, Spano JP, Keynan N, Funck-Brentano C, Salem JE. Clinical pharmacology of anti-angiogenic drugs in oncology. Crit Rev Oncol Hematol. 2017 Nov;119:75-93. doi: 10.1016/j.critrevonc.2017.08.010. Epub 2017 Sep 1.
PubMed 28916378
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Reporting of VEGF Inhibitors Associated Cardiovasclular Adverse reactioNs Using International Pharmacovigilance Database.
- ClinicalTrials.gov ID
- NCT03413176
- Acronym / sponsor ID
- VEGAN / CIC1421-18-02
- Conditions
- Cardiac Complication, Vascular Diseases
- Keywords
- VEGFR, VEGF, antiangiogenics, angiogenesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150,000 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with an AA for a cancer
Key inclusion criteria (3 listed)
- 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:
Key exclusion criteria (1 listed)
- Chronology not compatible between the drug and the toxicity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac complication induced by VEGF/VEGFR inhibitorCase reported in the World Health Organization (WHO) of cardiac complication of patient treated by AAs, with a chronology compatible with the drug toxicity | Drug | – |
Primary outcome
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.
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Background: PubMed 29698683Alexandre J, Moslehi JJ, Bersell KR, Funck-Brentano C, Roden DM, Salem JE. Anticancer drug-induced cardiac rhythm disorders: Current knowledge and basic underlying mechanisms. Pharmacol Ther. 2018 Sep;189:89-103. doi: 10.1016/j.pharmthera.2018.04.009. Epub 2018 Apr 24.
- Background: PubMed 28916378Gougis P, Wassermann J, Spano JP, Keynan N, Funck-Brentano C, Salem JE. Clinical pharmacology of anti-angiogenic drugs in oncology. Crit Rev Oncol Hematol. 2017 Nov;119:75-93. doi: 10.1016/j.critrevonc.2017.08.010. Epub 2017 Sep 1.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Complication and Vascular Diseases, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03413176, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.