Drug-Induced Sudden Death & Ventricular Arrhythmia
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|ClinicalTrials.gov Identifier: NCT00102180|
Recruitment Status : Completed
First Posted : January 24, 2005
Last Update Posted : December 2, 2015
|Condition or disease|
|Cardiovascular Diseases Death, Sudden, Cardiac Heart Diseases Ventricular Arrhythmia|
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.
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.
|Study Type :||Observational|
|Actual Enrollment :||31000000 participants|
|Observational Model:||Case Control|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
- All cause death [ Time Frame: All data years ]
- Composite outcome of sudden death and ventricular arrhythmia [ Time Frame: All data years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102180
|Principal Investigator:||Sean Hennessy, PharmD, PhD||University of Pennsylvania|