Status:
COMPLETED
Atorvastatin For The Reduction Of Ventricular Arrhythmias
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Arrhythmia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 (ventric...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00457340
Start Date
February 1 2000
End Date
September 1 2004
Last Update
February 18 2021
Active Locations (10)
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1
Pfizer Investigational Site
Aalst, Belgium
2
Pfizer Investigational Site
Antwerp, Belgium
3
Pfizer Investigational Site
Bruges, Belgium
4
Pfizer Investigational Site
Edegem, Belgium