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

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ClinicalTrials.gov Identifier: NCT00252967
Recruitment Status : Terminated (Insufficient power to show therapy difference at interim analysis.)
First Posted : November 15, 2005
Results First Posted : September 3, 2014
Last Update Posted : September 3, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Samuel C. Dudley, Jr., Emory University

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 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Inflammation Drug: Atorvastatin Drug: Placebo Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Atorvastatin Therapy for the Prevention of Atrial Fibrillation (SToP-AF)
Study Start Date : October 2005
Actual Primary Completion Date : November 2008
Actual Study Completion Date : October 2009


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo taken daily
Drug: Placebo
Experimental: Atorvastatin
Atorvastatin at a dose of 80 mg daily
Drug: Atorvastatin
80 mg of Atorvastatin




Primary Outcome Measures :
  1. Time of Atrial Fibrillation Recurrence [ Time Frame: Upon recurrence, up to 12 months ]

Secondary Outcome Measures :
  1. Comparison of Redox Potential for Cysteine Values [ Time Frame: Baseline and 30 days ]
  2. Comparison of Redox Potential for Glutathione Values [ Time Frame: Baseline and 30 days ]
  3. Comparison of Derivatives of Reactive Oxygen Metabolites Values [ Time Frame: Baseline and 30 days ]
  4. Comparison of Isoprostanes Values [ Time Frame: Baseline and 30 days ]
  5. Comparison of Interleukin-6 Values [ Time Frame: Baseline and 30 days ]
  6. Comparison of Interleukin-1 Values [ Time Frame: Baseline and 30 days ]
  7. Comparison of High Sensitivity C-reactive Protein [ Time Frame: Baseline and 30 days ]
  8. Comparison of Tumor Necrosis Factor Alpha Values [ Time Frame: Baseline and 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00252967


Locations
United States, Georgia
Veteran Administration Medical Center/Emory University
Atlanta, Georgia, United States, 30033
Crawford Long Hospital
Atlanta, Georgia, United States, 30322
The Emory Clinic
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Pfizer
Investigators
Principal Investigator: Samuel D. Dudley, Jr., MD, PhD Veterans Administration Medical Center

Publications of Results:
Negi, S., Shukrullah, I., Veladar, E., Bloom, H., Jones, D., S.C. Dudley, Jr. (2010). Statin Therapy for Prevention of Atrial Fibrillation Trial (SToP AF trial). [Abstract]. ACC 2010. 10-A-11608-ACC.

Responsible Party: Samuel C. Dudley, Jr., MD, Emory University
ClinicalTrials.gov Identifier: NCT00252967     History of Changes
Other Study ID Numbers: IRB00024771
1137-2004 ( Other Identifier: Other )
First Posted: November 15, 2005    Key Record Dates
Results First Posted: September 3, 2014
Last Update Posted: September 3, 2014
Last Verified: August 2014

Keywords provided by Samuel C. Dudley, Jr., Emory University:
Reactive Oxgen Speers
Atrial Fibrillation
Oxidative Stress
Inflammation

Additional relevant MeSH terms:
Inflammation
Atrial Fibrillation
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors