NCT00102180

Brief Summary

To investigate the relationship between the use of prescription drugs and the occurrence of ventricular arrhythmia and sudden death.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31,000,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

3.8 years

First QC Date

January 21, 2005

Last Update Submit

December 17, 2020

Conditions

Cardiovascular DiseasesDeath, Sudden, CardiacHeart DiseasesVentricular Arrhythmia

Outcome Measures

Primary Outcomes (1)

  • All cause death

    All data years

Secondary Outcomes (1)

  • Composite outcome of sudden death and ventricular arrhythmia

    All data years

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Medicaid enrollees from CA, FL, NY, OH and PA combined with the UK General Practice Research Database.

This combined database will be used to conduct a series of nested case-control and case-crossover studies to measure the absolute and relative rate of all-cause death and sudden death/ventricular arrhythmia (SD/VA) associated with five of the most commonly used drug classes of greatest concern: antipsychotics, antidepressants, opioid analgesics, quinolone antibiotics, and macrolide antibiotics.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular DiseasesDeath, Sudden, CardiacHeart Diseases

Condition Hierarchy (Ancestors)

Heart ArrestDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sean Hennessy, PharmD, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Epidemiology & of Pharmacology

Study Record Dates

First Submitted

January 21, 2005

First Posted

January 24, 2005

Study Start

January 1, 2005

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

December 21, 2020

Record last verified: 2020-12