Atorvastatin Therapy for the Prevention of Atrial Fibrillation (SToP-AF)
Condition: Atrial Fibrillation; Inflammation
MeSH terms: Atrial Fibrillation; Inflammation
Intervention: Atorvastatin; Placebo
Intervention description: 80 mg of Atorvastatin
Intervention MeSH terms: Atorvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Reactive Oxgen Speers; Atrial Fibrillation; Oxidative Stress; Inflammation

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.
    

Eligibility 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