Atorvastatin Therapy for the Prevention of Atrial Fibrillation (SToP-AF)

• Status: Terminated
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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 Food and Drug Administration (FDA) for the treatment of high cholesterol but is not approved for preventing abnormal heartbeats. In addition to lowering cholesterol, the drug reduces inflammation. Inflammation seems to help cause atrial fibrillation, a certain type of abnormal heartbeat. In animals, atorvastatin reduces the risk of this type of abnormal beats, and preliminary data in humans supports an effect of atorvastatin and other similar drugs that have the same action on reducing the risk of this type of abnormal beats. We, the researchers at Emory University, would like to learn if this drug could prevent the return of these abnormal heartbeats.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: Pfizer
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• > 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 Criteria:

• < 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