- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00457340
Atorvastatin For The Reduction Of Ventricular Arrhythmias (CLARIDI)
February 17, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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.
Study Overview
Study Type
Interventional
Enrollment
220
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aalst, Belgium
- Pfizer Investigational Site
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Antwerpen, Belgium
- Pfizer Investigational Site
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Brugge, Belgium
- Pfizer Investigational Site
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Edegem, Belgium
- Pfizer Investigational Site
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Gent, Belgium
- Pfizer Investigational Site
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Hasselt, Belgium
- Pfizer Investigational Site
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Leuven, Belgium
- Pfizer Investigational Site
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Athens, Greece
- Pfizer Investigational Site
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Crete, Greece
- Pfizer Investigational Site
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RIO Patra, Greece
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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Combined total mortality and major cardiovascular events.
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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).
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Total number of appropriate ICD interventions for ventricular arrhythmias and total number of episodes of electrical storm.
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An episode of electrical storm is defined as the occurrence within 24 hours of three or more ventricular arrhythmias requiring ICD intervention.
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Combined total mortality, major cardiovascular events and total number of appropriate ICD interventions for ventricular arrhythmias.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2000
Study Completion (Actual)
September 1, 2004
Study Registration Dates
First Submitted
April 4, 2007
First Submitted That Met QC Criteria
April 5, 2007
First Posted (Estimate)
April 6, 2007
Study Record Updates
Last Update Posted (Actual)
February 18, 2021
Last Update Submitted That Met QC Criteria
February 17, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A2581020
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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