Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00457340
Previous Study | Return to List | Next Study

Atorvastatin For The Reduction Of Ventricular Arrhythmias (CLARIDI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00457340
Recruitment Status : Completed
First Posted : April 6, 2007
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE April 4, 2007
First Posted Date  ICMJE April 6, 2007
Last Update Posted Date February 18, 2021
Study Start Date  ICMJE February 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2007)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2007)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Atorvastatin For The Reduction Of Ventricular Arrhythmias
Official Title  ICMJE Cholesterol Lowering and Arrhythmia Recurrences After Internal Defibrillator Implantation (CLARIDI)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Arrhythmia
Intervention  ICMJE Drug: Atorvastatin 80mg
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: April 5, 2007)
220
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00457340
Other Study ID Numbers  ICMJE A2581020
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2021

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