CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 104 enrolled
Drug / intervention
ICIdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03387540
NCT03387540N/ACompleted
CompareCT.gov

Evaluation of Reporting of Immune Checkpoint Inhibitor Associated Cardio-vascular Adverse Reactions Using International Pharmacovigilance Database

Groupe Hospitalier Pitie-Salpetriere·observational·Posted Jan 2, 2018·Updated Sep 26, 2019

In Brief

An observational study evaluating ICI for Myocarditis and Cardiac Complication. Completed, enrolled 104 participants across 1 site.

Detailed Summary

Immune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events (irAEs) on the cardio-vascular system. This study investigates reports of cardio-vascular toxicity with treatment including anti-PD1, Anti-PDL-1, and Anti CTLA4 classes using the World Health Organization (WHO) database VigiBase.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMyocarditis, Cardiac Complication
CountriesFrance
CollaboratorsInstitute of Cardiometabolism and Nutrition, France, Vanderbilt University, Vanderbilt University Medical Center

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 2, 2018
Enrollment StartDec 2, 2017
Primary CompletionDec 4, 2017
Study CompletionDec 31, 2017
TodayJul 2, 2026
Enrollment to primary: 2 daysPosted 8.5 years ago

Interventions

ICIdrug

Immune checkpoint inhibitor targeting either PD-1, PD-L1 or CTLA-4, and included in the following list (ATC classification): Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32).