Drug-Induced Sudden Death & Ventricular Arrhythmia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sean Hennessy, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00102180
First received: January 21, 2005
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

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


Condition
Cardiovascular Diseases
Death, Sudden, Cardiac
Heart Diseases
Ventricular Arrhythmia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • All cause death [ Time Frame: All data years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Composite outcome of sudden death and ventricular arrhythmia [ Time Frame: All data years ] [ Designated as safety issue: No ]

Enrollment: 31000000
Study Start Date: January 2005
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

Drug-induced sudden cardiac death (also called sudden death, SD) and ventricular arrhythmia (VA) have arisen as major public health concerns in the last decade. Sudden death/ventricular arrhythmia have resulted in the withdrawal of more drugs in recent years than any other adverse drug reaction, and the identification of over 100 non-cardiac drugs as suspected of being high-risk. Unfortunately, controlled studies measuring the risks associated with specific drugs are very few in number, presumably because of the complexity of such studies and the massive sample sizes needed to study this outcome. Even studies in "large" databases have lacked adequate statistical power for crucial subgroup analyses. This lack of controlled data on clinical sudden death/ventricular arrhythmia has necessitated reliance on uncontrolled observations and on studies of putative markers of risk such as QTc prolongation in the electrocardiogram. However, the utility of uncontrolled observations is always subject to question, and the validity of these putative markers remains unknown. As a result, clinicians, patients, regulators, and drug manufacturers are ill-equipped to address the critical clinical and public health decisions concerning drug-induced sudden death/ventricular arrhythmia.

DESIGN NARRATIVE:

This study will compile a massive new pharmacoepidemiologic database of Medicaid data (linked with Medicare data for those enrolled in both programs, and with the Social Security Administration Death Masterfile) from five large Medicaid programs. This will be 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. A multi-stage investigative strategy will be used: Stage 1 will compile the database, assure its quality, and reproduce known associations. Stage 2a will compare drugs among the classes of interest. Stage 2b will use the case-crossover design to look for associations controlling for stable patient factors. Stage 2c will examine the effect of dose and inhibitors of pharmacokinetic clearance, the functional equivalent of high-dose use. Stage 3 will develop predictive indices to stratify patient subgroups receiving high-risk drugs.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102180

Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Sean Hennessy, PharmD, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Sean Hennessy, Associate Professor of Epidemiology & of Pharmacology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00102180     History of Changes
Other Study ID Numbers: 1287, 5R01HL076697
Study First Received: January 21, 2005
Last Updated: April 8, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Cardiovascular Diseases
Death
Death, Sudden
Heart Diseases
Death, Sudden, Cardiac
Pathologic Processes
Heart Arrest

ClinicalTrials.gov processed this record on August 26, 2014