Clinical trial NCT00457340: Atorvastatin For The Reduction Of Ventricular Arrhythmias
Official title: Cholesterol Lowering and Arrhythmia Recurrences After Internal Defibrillator Implantation (CLARIDI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arrhythmia
Keywords: Tachycardia, Ventricular
Ventricular Fibrillation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-04-06
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: 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 outcomes:
measure: Combined total mortality and major cardiovascular events.
measure: 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).
measure: Total number of appropriate ICD interventions for ventricular arrhythmias and total number of episodes of electrical storm.
measure: An episode of electrical storm is defined as the occurrence within 24 hours of three or more ventricular arrhythmias requiring ICD intervention.
measure: Combined total mortality, major cardiovascular events and total number of appropriate ICD interventions for ventricular arrhythmias.
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Pfizer Investigational Site
city: Antwerpen
country: Belgium
facility: Pfizer Investigational Site
city: Brugge
country: Belgium
facility: Pfizer Investigational Site
city: Edegem
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Hasselt
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Crete
country: Greece
facility: Pfizer Investigational Site
city: RIO Patra
country: Greece
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: