Atorvastatin For The Reduction Of Ventricular Arrhythmias (CLARIDI)

Viatris

Status and phase

Completed

Phase 4

Conditions

Arrhythmia

Treatments

Drug: Atorvastatin 80mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00457340

A2581020

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

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).