Arrhythmia
Conditions
Keywords
Tachycardia, Ventricular, Ventricular Fibrillation
Brief summary
To assess in patients with CAD \[coronary artery disease\] and an implantable defibrillator the effect of atorvastatin 80 mg versus placebo on the first recurrence of a ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation requiring ICD \[implantable cardioverter defibrillator\] intervention) within one year after randomization.
Interventions
DRUGAtorvastatin 80mg
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible subjects were male or female subjects, age \>18 years, with clinically documented coronary artery disease and life-threatening ventricular arrhythmias who met the following criteria: * Were scheduled for an ICD implantation or had an ICD implantation within 1 month, according to the class I American College of Cardiology/American Heart Association (ACC/AHA) practice guidelines for ICD therapy OR * Were already treated with an ICD for a class I ACC/AHA indication for more than one month, provided they received at least one appropriate ICD intervention (shock or antitachycardia pacing (ATP) for ventricular tachycardia or ventricular fibrillation) during the preceding six months
Exclusion criteria
* Patients with ventricular arrhythmias in the acute phase of myocardial infarction (first 48 hours). * Patients with incessant ventricular tachycardia. * Patients with ventricular arrhythmias without underlying coronary artery disease. * Patients with a transient or reversible cause of ventricular arrhythmias (including significant electrolyte disturbances or drug induced proarrhythmia).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess in patients with CAD and an implantable defibrillator the effect of atorvastatin 80 mg versus placebo on the first recurrence of a ventricular arrhythmia after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Combined total mortality and major cardiovascular events. | — |
| Major cardiovascular events include acute myocardial infarction, stroke and PTCA [percutaneous coronary angioplasty] (with or without stenting) or CABG [coronary artery bypass graft] (CABG already foreseen at the moment of randomization). | — |
| Total number of appropriate ICD interventions for ventricular arrhythmias and total number of episodes of electrical storm. | — |
| An episode of electrical storm is defined as the occurrence within 24 hours of three or more ventricular arrhythmias requiring ICD intervention. | — |
| Combined total mortality, major cardiovascular events and total number of appropriate ICD interventions for ventricular arrhythmias. | — |
Countries
Belgium, Greece
Outcome results
None listed