Status:
TERMINATED
Atorvastatin Therapy for the Prevention of Atrial Fibrillation (SToP-AF)
Lead Sponsor:
Emory University
Collaborating Sponsors:
Pfizer
Conditions:
Atrial Fibrillation
Inflammation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to test whether the drug, atorvastatin, will be able to reduce the rate of return of the abnormal beats after using cardioversion. Atorvastatin is a drug approved by the F...
Detailed Description
Atrial fibrillation (AF) and its related disorder, atrial flutter (AFlut), are common abnormal heartbeats. Because they are similar and AFlut is rare compared to AF, they are usually treated similarly...
Eligibility Criteria
Inclusion
- \> or = 18 years of age
- Clinical diagnosis-abnormal heart beat known as atrial fibrillation/flutter (ECG documentation)
- Able to swallow pill form of drug
Exclusion
- \< 18 years of age
- enrollment in another ongoing trial
- paroxysmal atrial fibrillation
- hemodynamic instability
- atrial fibrillation ablation within 6 months of enrollment
- a contraindication for anticoagulation
- severe valvular heart disease
- presence of single lead implantable cardioverter defibrillator
- unstable angina
- New York Heart Association (NYHA) Class IV heart failure
- hyperthyroidism
- uncontrolled hypertension (blood pressure \> 180/100 at rest) on medications
- an illness that would limit life expectancy to less than 1 year
- use of statins within the previous 30 days
- significant coronary artery disease or lipid abnormalities necessitating statin therapy
- implanted devices for active management of arrhythmias by pacing or defibrillation
- lack of access to a telephone
- illicit drug use
- alcohol abuse
- hypersensitivity to atorvastatin by history
- pregnancy
- sexually active female subjects not on contraception or surgically sterilized
- nursing mothers
- chronic liver disease or abnormal liver function (elevated transaminases 1.5 times the upper limit of normal \[ULN\] of laboratory reference range)
- severe renal disease (creatinine \> 200 mmol/L)
- inflammatory muscle disease or creatine kinase (CK) \> 3 times ULN
- concurrent treatment with cyclosporine, fibrates, or high-dose niacin
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00252967
Start Date
October 1 2005
End Date
October 1 2009
Last Update
September 3 2014
Active Locations (3)
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1
Veteran Administration Medical Center/Emory University
Atlanta, Georgia, United States, 30033
2
Crawford Long Hospital
Atlanta, Georgia, United States, 30322
3
The Emory Clinic
Atlanta, Georgia, United States, 30322