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Atorvastatin For The Reduction Of Ventricular Arrhythmias (CLARIDI)

Primary Purpose

Arrhythmia

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Atorvastatin 80mg
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrhythmia focused on measuring Tachycardia, Ventricular, Ventricular Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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).

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

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.

Full Information

First Posted
April 4, 2007
Last Updated
February 17, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00457340
Brief Title
Atorvastatin For The Reduction Of Ventricular Arrhythmias
Acronym
CLARIDI
Official Title
Cholesterol Lowering and Arrhythmia Recurrences After Internal Defibrillator Implantation (CLARIDI)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia
Keywords
Tachycardia, Ventricular, Ventricular Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
220 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Atorvastatin 80mg
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Combined total mortality and major cardiovascular events.
Title
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).
Title
Total number of appropriate ICD interventions for ventricular arrhythmias and total number of episodes of electrical storm.
Title
An episode of electrical storm is defined as the occurrence within 24 hours of three or more ventricular arrhythmias requiring ICD intervention.
Title
Combined total mortality, major cardiovascular events and total number of appropriate ICD interventions for ventricular arrhythmias.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Aalst
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Antwerpen
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Brugge
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Edegem
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Gent
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Hasselt
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Leuven
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Athens
Country
Greece
Facility Name
Pfizer Investigational Site
City
Crete
Country
Greece
Facility Name
Pfizer Investigational Site
City
RIO Patra
Country
Greece

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581020&StudyName=Atorvastatin+For+The+Reduction+Of+Ventricular+Arrhythmias
Description
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Atorvastatin For The Reduction Of Ventricular Arrhythmias

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