NCT00457340

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2000

Longer than P75 for phase_4

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2007

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

First QC Date

April 4, 2007

Last Update Submit

February 17, 2021

Conditions

Arrhythmia

Keywords

Tachycardia, VentricularVentricular Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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.

Interventions

Atorvastatin 80mgDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Pfizer Investigational Site

Aalst, Belgium

Location

Pfizer Investigational Site

Antwerp, Belgium

Location

Pfizer Investigational Site

Bruges, Belgium

Location

Pfizer Investigational Site

Edegem, Belgium

Location

Pfizer Investigational Site

Ghent, Belgium

Location

Pfizer Investigational Site

Hasselt, Belgium

Location

Pfizer Investigational Site

Leuven, Belgium

Location

Pfizer Investigational Site

Athens, Greece

Location

Pfizer Investigational Site

Crete, Greece

Location

Pfizer Investigational Site

RIO Patra, Greece

Location

Related Links

MeSH Terms

Conditions

Arrhythmias, CardiacTachycardia, VentricularVentricular Fibrillation

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsTachycardiaCardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2007

First Posted

April 6, 2007

Study Start

February 1, 2000

Study Completion

September 1, 2004

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations

GR(3)BE(7)