Atorvastatin For The Reduction Of Ventricular Arrhythmias

Official Title: “Cholesterol Lowering and Arrhythmia Recurrences After Internal Defibrillator Implantation (CLARIDI)”

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.

Intervention(s) in this Clinical Trial

• Drug: Atorvastatin 80mg

Primary Measures

• 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 Measures

• 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.

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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00457340

Study ID Number: A2581020

ClinicalTrials.gov Identifier: NCT00457340

Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

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