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

This study has been terminated.
(Insufficient power to show therapy difference at interim analysis.)
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Samuel C. Dudley, Jr., Emory University
ClinicalTrials.gov Identifier:
NCT00252967
First received: November 14, 2005
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Atrial Fibrillation
Inflammation
Drug: Atorvastatin
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Atorvastatin Therapy for the Prevention of Atrial Fibrillation (SToP-AF)

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • The treatment will be 80 mg/day orally compound for one year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • A secondary endpoint will be the ability of the intervention to decrease oxidative stress at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 63
Study Start Date: October 2005
Study Completion Date: October 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
This will be a double blind, placebo controlled trial compared to Atorvastatin and will be analyzed on an intention to treat basis.
Drug: Atorvastatin
If patients agree to participate, then they will be started on the study drug, 80 mg of Atorvastatin or placebo and followed for recurrence of AF by a variety of surface electrocardiogram techniques. All of which are noninvasive. To insure the medicine is not causing side effects, examinations and blood tests will be done, and to study whether the drug actually affects oxidative stress, blood will be analyzed. The subjects participation ends when AF recurs or after 1 year. This will be a double blind, placebo controlled trial and will be analyzed on an intention to treat basis.
Other Name: Atorvastatin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis-abnormal heart beat known as atrial fibrillation
  • Able to swallow pill form of drug

Exclusion Criteria:

  • Younger or older than 18-65 years of age.
  • Not undergoing cardioversion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252967

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

Publications:
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: 1137-2004
Study First Received: November 14, 2005
Last Updated: September 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Reactive Oxgen Speers
Atrial Fibrillation
Oxidative Stress
Inflammation

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

ClinicalTrials.gov processed this record on August 28, 2014