Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102180
Status:
COMPLETED
Last Update Posted:
2020-12-21
First Post:
2005-01-21
Brief Title:
Drug-Induced Sudden Death Ventricular Arrhythmia
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate the relationship between the use of prescription drugs and the occurrence of ventricular arrhythmia and sudden death
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 deathventricular 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 deathventricular 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 deathventricular 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 deathventricular arrhythmia SDVA 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
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 deathventricular 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 deathventricular 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 deathventricular 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 deathventricular arrhythmia SDVA 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01HL076697 | NIH | None | httpsreporternihgovquickSearch5R01HL076697 |