Study Stopped
Insufficient power to show therapy difference at interim analysis.
Atorvastatin Therapy for the Prevention of Atrial Fibrillation (SToP-AF)
2 other identifiers
interventional
64
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 atrial-fibrillation
Started Oct 2005
Typical duration for phase_3 atrial-fibrillation
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 14, 2005
CompletedFirst Posted
Study publicly available on registry
November 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
September 3, 2014
CompletedSeptember 3, 2014
August 1, 2014
3.1 years
November 14, 2005
April 21, 2014
August 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time of Atrial Fibrillation Recurrence
Upon recurrence, up to 12 months
Secondary Outcomes (8)
Comparison of Redox Potential for Cysteine Values
Baseline and 30 days
Comparison of Redox Potential for Glutathione Values
Baseline and 30 days
Comparison of Derivatives of Reactive Oxygen Metabolites Values
Baseline and 30 days
Comparison of Isoprostanes Values
Baseline and 30 days
Comparison of Interleukin-6 Values
Baseline and 30 days
- +3 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo taken daily
Atorvastatin
EXPERIMENTALAtorvastatin at a dose of 80 mg daily
Interventions
Eligibility Criteria
You may qualify if:
- \> or = 18 years of age
- Clinical diagnosis-abnormal heart beat known as atrial fibrillation/flutter (ECG documentation)
- Able to swallow pill form of drug
You may not qualify if:
- \< 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
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- Pfizercollaborator
Study Sites (3)
Veteran Administration Medical Center/Emory University
Atlanta, Georgia, 30033, United States
Crawford Long Hospital
Atlanta, Georgia, 30322, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Related Publications (1)
Negi S, Shukrullah I, Veledar E, Bloom HL, Jones DP, Dudley SC. Statin therapy for the prevention of atrial fibrillation trial (SToP AF trial). J Cardiovasc Electrophysiol. 2011 Apr;22(4):414-9. doi: 10.1111/j.1540-8167.2010.01925.x. Epub 2010 Oct 13.
PMID: 20946227RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Limited enrollment; recurrence rate of AF was slightly higher than other trials indicated that the study sample may be a high-risk population.
Results Point of Contact
- Title
- Samuel Dudley, MD, PhD
- Organization
- Brown University
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel D. Dudley, Jr., MD, PhD
US Department of Veterans Affairs
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 14, 2005
First Posted
November 15, 2005
Study Start
October 1, 2005
Primary Completion
November 1, 2008
Study Completion
October 1, 2009
Last Updated
September 3, 2014
Results First Posted
September 3, 2014
Record last verified: 2014-08