CLARIDI: Atorvastatin For The Reduction Of Ventricular Arrhythmias

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00457340

Collaborator

(none)

220

Enrollment

Locations

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arrhythmia	Drug: Atorvastatin 80mg	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2000

Actual Study Completion Date :

Sep 1, 2004

Outcome Measures

Primary Outcome 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 Outcome 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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	Country
1	Pfizer Investigational Site	Aalst	Belgium
2	Pfizer Investigational Site	Antwerpen	Belgium
3	Pfizer Investigational Site	Brugge	Belgium
4	Pfizer Investigational Site	Edegem	Belgium
5	Pfizer Investigational Site	Gent	Belgium
6	Pfizer Investigational Site	Hasselt	Belgium
7	Pfizer Investigational Site	Leuven	Belgium
8	Pfizer Investigational Site	Athens	Greece
9	Pfizer Investigational Site	Crete	Greece
10	Pfizer Investigational Site	RIO Patra	Greece