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PubMed
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Stroke Interventions in Clinical Trials
Printable Version
SToP-AF
Atorvastatin Therapy for the Prevention of Atrial Fibrillation



Principal Investigator
Samuel C. Dudley, Jr., MD, PhD

PI Address
Samuel C. Dudley, Jr., M.D., Ph.D.
Associate Professor of Medicine and Physiology
Emory University
Chief, Division of Cardiology, Atlanta VA Medical Center
1670 Clairmont Road (111B)
Decatur, GA 30033
tel: 404-329-4626
fax: 404-329-2211
email: sdudley@emory.edu

Contact Email
sdudley@emory.edu

Sponsor



Trial Phase:Phase III
Study Size Planned:258
Centers Planned:1
Max Age:65
Min Age:18
Follow-up Duration:1 Years
ISRCTN#NCT00252967
Status:
This study has been terminated. This study was terminated because it was unlikely to have sufficient power to show a difference with therapy on an interim analysis.

Purpose:
To test whether the drug, atorvastatin, will be able to reduce the rate of return of the abnormal beats after using cardioversion.

Interventions:
Atorvastatin
Competitive inhibitor of HMG-CoA reductase; lowers cholesterol and lipids

Location(s):
Georgia

Year Started: 2005

Design:
Interventional, Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study.

Inclusion Criteria
Clinical diagnosis-abnormal heart beat known as atrial fibrillation; able to swallow pill form of drug.

Patient Involvement:
Once the decision is made to have the patient undergo cardioversion, we will approach the patient about enrolling in this trial. The only change in their medical therapy will be the addition of the study drug. The study requires no other alterations to the standard of care. If patients agree to participate, then they will be started on the study drug 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.

Primary Outcome:
The treatment will be 80 mg/day orally compound for one year

Secondary Outcome:
A secondary endpoint will be the ability of the intervention to decrease oxidative stress at 30 days

Results:
Results publication:
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.

Comments:
Scientific Name: Atorvastatin Therapy for the Prevention of Atrial Fibrillation (SToP-AF)

Source of Information:
ClinicalTrials.gov

Web Links and Publications:
SToP-AF
ClinicalTrials.gov

This information last updated on: 10/30/2009

Reviewed on: 10/30/2009.

UID: 993

   

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