Torsades de Pointe Caused by DrugNCT04293432
A Pharmacovigilance Study of Torsade de Pointes
An observational study of Torsades de Pointe Caused by Drug, run by University of Peshawar at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Torsades de Pointe Caused by Drug
- What is being tested?
- Drugs, Generic
- How many people
- 6,670 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2019to 1 Jan 2020
- How long will I take part?
- 1 Day
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients presented with TdP treated for any disease
Who may be able to join
- TdP cases reported in the FAERS database till 31/03/2019
- Adverse event reported was including the MedDRA term: Torsade de Pointes
Who cannot join
- Drugs with less than 10 TdP reports
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Department of Pharmacy, University of Peshawar
Peshawar, Khyber Pakhtunkhwa, 25000
About this study
Official title: A Pharmacovigilance Study of Torsade de Pointes in the Food and Drug Administration Adverse Event Reporting System Using Data Mining Algorithms
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.
Read the detailed description
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.
- Conditions
- Torsades de Pointe Caused by Drug
- Being tested
- Drugs, Generic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drugs, GenericDrug
All drugs having ≥10 TdP cases reported in the FAERS database
| Study group | Role | What they receive |
|---|---|---|
| Group/Cohort | Torsade de Pointes induced by drugs reported to the FAERS database from inception till first quarter of 2019 (1990-2019) Receives: Drug: Drugs, Generic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of drugs associated with TdP
The search includes MedDRA (v-22) Preferred Term, "Torsade de Pointes (MedDRA code: 10044066) for the identification of all TdP case reports and drugs.
Measured: Cases reported to the FAERS database till 31/03/2019
Identification of new signals of TdP
Signal detection using disproportionality analysis
Measured: Cases reported to the FAERS database till 31/03/2019
Secondary outcomes (5)
Validation of already known drug-TdP associations
Measured: Cases reported to the FAERS database till 31/03/2019
Stratification of new signals with respect to age
Measured: Cases reported to the FAERS database till 31/03/2019
Stratification of new signals with respect to gender
Measured: Cases reported to the FAERS database till 31/03/2019
Trends of TdP reports in FAERS database
Measured: Cases reported to the FAERS database till 31/03/2019
Description of the population of patients having TdP
Measured: Cases reported to the FAERS database till 31/03/2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start15 May 2019
- Primary completion22 Dec 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Torsades de Pointe Caused by DrugStudies 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
- 6,670 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Peshawar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Ismail, University of Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293432
- Sponsor's protocol ID
- PV-TdP
- Status last verified
- Feb 2020
- First submitted
- 14 Feb 2020
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ali Z, Ismail M, Rehman IU, Goh KW, Razi P, Ming LC. Association of anxiolytic drugs with Torsade de Pointes: a pharmacovigilance study of the Food and Drug Administration Adverse Event Reporting System. J Pharm Policy Pract. 2024 Sep 16;17(1):2399716. doi: 10.1080/20523211.2024.2399716. eCollection 2024.
PubMed 39291052
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacovigilance Study of Torsade de Pointes in the Food and Drug Administration Adverse Event Reporting System Using Data Mining Algorithms
- ClinicalTrials.gov ID
- NCT04293432
- Acronym / sponsor ID
- PV-TdP
- Conditions
- Torsades de Pointe Caused by Drug
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,670 participants (actual)
- Lead sponsor
- University of PeshawarUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 22 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 3 Mar 2020 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group/Cohort | – | Drug: Drugs, GenericTorsade de Pointes induced by drugs reported to the FAERS database from inception till first quarter of 2019 (1990-2019) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presented with TdP treated for any disease
Key inclusion criteria (2 listed)
- TdP cases reported in the FAERS database till 31/03/2019
- Adverse event reported was including the MedDRA term: Torsade de Pointes
Key exclusion criteria (1 listed)
- Drugs with less than 10 TdP reports
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 |
|---|---|---|
| Drugs, GenericAll drugs having ≥10 TdP cases reported in the FAERS database | Drug | Group/Cohort |
Primary outcome
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.
Identification of new signals of TdP
Time frame: Cases reported to the FAERS database till 31/03/2019
Signal detection using disproportionality analysis
5 secondary outcomes
Validation of already known drug-TdP associations
Time frame: Cases reported to the FAERS database till 31/03/2019
Stratification of new signals with respect to age
Time frame: Cases reported to the FAERS database till 31/03/2019
Stratification of new signals with respect to gender
Time frame: Cases reported to the FAERS database till 31/03/2019
Trends of TdP reports in FAERS database
Time frame: Cases reported to the FAERS database till 31/03/2019
Description of the population of patients having TdP
Time frame: Cases reported to the FAERS database till 31/03/2019
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 3 Mar 2020.
- Derived from this study: PubMed 39291052Ali Z, Ismail M, Rehman IU, Goh KW, Razi P, Ming LC. Association of anxiolytic drugs with Torsade de Pointes: a pharmacovigilance study of the Food and Drug Administration Adverse Event Reporting System. J Pharm Policy Pract. 2024 Sep 16;17(1):2399716. doi: 10.1080/20523211.2024.2399716. eCollection 2024.
- 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 Torsades de Pointe Caused by Drug, run by University of Peshawar at 1 site in Pakistan.
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 2 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 3 Mar 2020. 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 Pakistan. 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?
Identification of drugs associated with TdP (time frame: Cases reported to the FAERS database till 31/03/2019). The study lists 2 primary outcomes in all. 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 NCT04293432, which also lists 1 linked publication.
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 3 Mar 2020.