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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: August 21, 2014
Last verified: August 2014
Results First Received: April 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Conditions: Atrial Fibrillation
Inflammation
Interventions: Drug: Atorvastatin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo No text entered.
Atorvastatin No text entered.

Participant Flow:   Overall Study
    Placebo     Atorvastatin  
STARTED     31     33  
COMPLETED     31     33  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Placebo No text entered.
Atorvastatin No text entered.
Total Total of all reporting groups

Baseline Measures
    Placebo     Atorvastatin     Total  
Number of Participants  
[units: participants]
  31     33     64  
Age  
[units: years]
Mean ± Standard Deviation
  58.9  ± 13.9     58.2  ± 11.6     58.5  ± 12.8  
Gender  
[units: participants]
     
Female     5     6     11  
Male     26     27     53  



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

2.  Secondary:   Comparison of Redox Potential for Cysteine Values   [ Time Frame: Baseline and 30 days ]

3.  Secondary:   Comparison of Redox Potential for Glutathione Values   [ Time Frame: Baseline and 30 days ]

4.  Secondary:   Comparison of Derivatives of Reactive Oxygen Metabolites Values   [ Time Frame: Baseline and 30 days ]

5.  Secondary:   Comparison of Isoprostanes Values   [ Time Frame: Baseline and 30 days ]

6.  Secondary:   Comparison of Interleukin-6 Values   [ Time Frame: Baseline and 30 days ]

7.  Secondary:   Comparison of Interleukin-1 Values   [ Time Frame: Baseline and 30 days ]

8.  Secondary:   Comparison of High Sensitivity C-reactive Protein   [ Time Frame: Baseline and 30 days ]

9.  Secondary:   Comparison of Tumor Necrosis Factor Alpha Values   [ Time Frame: Baseline and 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limited enrollment; recurrence rate of AF was slightly higher than other trials indicated that the study sample may be a high-risk population.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Samuel Dudley, MD, PhD
Organization: Brown University
phone: 4014443024
e-mail: samuel_dudley@brown.edu


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., Emory University
ClinicalTrials.gov Identifier: NCT00252967     History of Changes
Other Study ID Numbers: IRB00024771, 1137-2004
Study First Received: November 14, 2005
Results First Received: April 21, 2014
Last Updated: August 21, 2014
Health Authority: United States: Food and Drug Administration