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
  Purpose

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 Intervention Phase
Arrhythmia
Drug: Atorvastatin 80mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Cholesterol Lowering and Arrhythmia Recurrences After Internal Defibrillator Implantation (CLARIDI)

Resource links provided by NLM:


Further study details as provided by Pfizer:

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.

Estimated Enrollment: 220
Study Start Date: February 2000
Study Completion Date: September 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457340

Locations
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, Belgium
Greece
Pfizer Investigational Site
Athens, Greece
Pfizer Investigational Site
Crete, Greece
Pfizer Investigational Site
Rio Patra, Greece
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00457340     History of Changes
Other Study ID Numbers: A2581020
Study First Received: April 4, 2007
Last Updated: June 17, 2009
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Pfizer:
Tachycardia, Ventricular
Ventricular Fibrillation

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014