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NCT Number: NCT04293432

A Pharmacovigilance Study of Torsade de Pointes

Many cardiac and non-cardiac drugs are associated with TdP that may constitute a significant problem because of sudden cardiac death. This study aims to present a comprehensive overview and disproportionality analysis of TdP cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) in order to identify new signals of TdP.

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Key information

Conditions

Torsades de Pointe Caused by Drug

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pharmacy, University of Peshawar

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

About this study

Drug-induced Torsade de Pointes (TdP) is a serious but an overlooked adverse drug reaction because a wide range of marketed drugs associated with TdP are commonly prescribed in routine practice. Owing to the heightened concern of a vast number of drug-TdP associations including newly approved drugs, the investigators, therefore, aims to investigate drug-TdP associations by performing disproportionality analysis in order to identify new signals of TdP utilizing the individual case reports of TdP in the FAERS database.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • TdP cases reported in the FAERS database till 31/03/2019
  • Adverse event reported was including the MedDRA term: Torsade de Pointes

Exclusion criteria

  • Drugs with less than 10 TdP reports

Treatment and study plan

Drugs, Generic

Drug

All drugs having ≥10 TdP cases reported in the FAERS database

Primary outcomes

  1. Identification of drugs associated with TdP

    Time frame: Cases reported to the FAERS database till 31/03/2019

    The search includes MedDRA (v-22) Preferred Term, "Torsade de Pointes (MedDRA code: 10044066) for the identification of all TdP case reports and drugs.

  2. Identification of new signals of TdP

    Time frame: Cases reported to the FAERS database till 31/03/2019

    Signal detection using disproportionality analysis

Secondary outcomes

  1. Validation of already known drug-TdP associations

    Time frame: Cases reported to the FAERS database till 31/03/2019

  2. Stratification of new signals with respect to age

    Time frame: Cases reported to the FAERS database till 31/03/2019

  3. Stratification of new signals with respect to gender

    Time frame: Cases reported to the FAERS database till 31/03/2019

  4. Trends of TdP reports in FAERS database

    Time frame: Cases reported to the FAERS database till 31/03/2019

  5. Description of the population of patients having TdP

    Time frame: Cases reported to the FAERS database till 31/03/2019

Sponsors and collaborators

Lead sponsor

University of Peshawar

Other

Registry information

Official study title

A Pharmacovigilance Study of Torsade de Pointes in the Food and Drug Administration Adverse Event Reporting System Using Data Mining Algorithms

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 3, 2020
Registry last updated
Mar 3, 2020

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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