Atorvastatin For The Reduction Of Ventricular Arrhythmias (CLARIDI)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00457340
First received: April 4, 2007
Last updated: June 17, 2009
Last verified: June 2009

April 4, 2007
June 17, 2009
February 2000
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00457340 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Atorvastatin For The Reduction Of Ventricular Arrhythmias
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Arrhythmia
Drug: Atorvastatin 80mg
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
September 2004
Not Provided

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Greece
 
NCT00457340
A2581020
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP