Atorvastatin For The Reduction Of Ventricular Arrhythmias

Arrhythmia Clinical Trial

— CLARIDI  

Official title:

Cholesterol Lowering and Arrhythmia Recurrences After Internal Defibrillator Implantation (CLARIDI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457340
• Other study ID #: A2581020
• Status: Completed
• Phase: Phase 4
• Start date: February 2000
• Est. completion date: September 2004

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arrhythmia
• Arrhythmias, Cardiac

Intervention

Drug:
• Atorvastatin 80mg

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Aalst
Belgium	Pfizer Investigational Site	Antwerpen
Belgium	Pfizer Investigational Site	Brugge
Belgium	Pfizer Investigational Site	Edegem
Belgium	Pfizer Investigational Site	Gent
Belgium	Pfizer Investigational Site	Hasselt
Belgium	Pfizer Investigational Site	Leuven
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Crete
Greece	Pfizer Investigational Site	RIO Patra

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Belgium,  Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Combined total mortality and major cardiovascular events.
Secondary	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).
Secondary	Total number of appropriate ICD interventions for ventricular arrhythmias and total number of episodes of electrical storm.
Secondary	An episode of electrical storm is defined as the occurrence within 24 hours of three or more ventricular arrhythmias requiring ICD intervention.
Secondary	Combined total mortality, major cardiovascular events and total number of appropriate ICD interventions for ventricular arrhythmias.

External Links

•   To obtain contact information for a study center near you, click here.