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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions Atrial Fibrillation
Inflammation
Interventions Drug: Atorvastatin
Drug: Placebo
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Atorvastatin
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 31 33
Completed 31 33
Not Completed 0 0
Arm/Group Title Placebo Atorvastatin Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 31 33 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 33 participants 64 participants
58.9  (13.9) 58.2  (11.6) 58.5  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 33 participants 64 participants
Female
5
  16.1%
6
  18.2%
11
  17.2%
Male
26
  83.9%
27
  81.8%
53
  82.8%
1.Primary Outcome
Title Time of Atrial Fibrillation Recurrence
Hide Description [Not Specified]
Time Frame Upon recurrence, up to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Atorvastatin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 31 33
Median (Inter-Quartile Range)
Unit of Measure: days
22
(7 to 70)
29
(2 to 145)
2.Secondary Outcome
Title Comparison of Redox Potential for Cysteine Values
Hide Description [Not Specified]
Time Frame Baseline and 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Atorvastatin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 31 33
Median (Inter-Quartile Range)
Unit of Measure: mV
Baseline
-61.2
(-71.2 to -54.8)
-65.3
(-71.3 to -58.8)
1 month (30 day follow-up)
-64.5
(-69.8 to -58.5)
-62.6
(-68.0 to -58.0)
3.Secondary Outcome
Title Comparison of Redox Potential for Glutathione Values
Hide Description [Not Specified]
Time Frame Baseline and 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Atorvastatin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 31 33
Median (Inter-Quartile Range)
Unit of Measure: mV
Baseline
-116.7
(-134.9 to -110.2)
-125.3
(-138.0 to -117.3)
1 month (30 day follow-up)
-124.3
(-142.1 to -109.0)
-129.0
(-138.2 to -113.4)
4.Secondary Outcome
Title Comparison of Derivatives of Reactive Oxygen Metabolites Values
Hide Description [Not Specified]
Time Frame Baseline and 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Atorvastatin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 31 33
Median (Inter-Quartile Range)
Unit of Measure: Carr
Baseline
384
(276 to 422)
382
(322 to 467)
1 month (30 day follow-up)
400
(338 to 450)
345
(304 to 406)
5.Secondary Outcome
Title Comparison of Isoprostanes Values
Hide Description [Not Specified]
Time Frame Baseline and 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Atorvastatin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 31 33
Median (Inter-Quartile Range)
Unit of Measure: pg/mL
Baseline
1259
(1040 to 1738)
1062
(817 to 1421)
1 month (30 day follow-up)
1146
(964 to 1397)
1240
(953 to 1397)
6.Secondary Outcome
Title Comparison of Interleukin-6 Values
Hide Description [Not Specified]
Time Frame Baseline and 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Atorvastatin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 31 33
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
Baseline
5.3
(2.1 to 9.2)
4.0
(1.7 to 6.6)
1 month (30 day follow-up)
5.6
(3.2 to 8.6)
2.2
(1.7 to 3.6)
7.Secondary Outcome
Title Comparison of Interleukin-1 Values
Hide Description [Not Specified]
Time Frame Baseline and 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Atorvastatin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 31 33
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
Baseline
0.29
(0.20 to 0.44)
0.30
(0.17 to 0.47)
1 month (30 day follow-up)
0.25
(0.17 to 0.32)
0.28
(0.21 to 0.32)
8.Secondary Outcome
Title Comparison of High Sensitivity C-reactive Protein
Hide Description [Not Specified]
Time Frame Baseline and 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Atorvastatin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 31 33
Median (Inter-Quartile Range)
Unit of Measure: mg/L
Baseline
9.6
(1.7 to 15.0)
6.3
(2.2 to 11.8)
1 month (30 day follow-up)
12.3
(2.8 to 14.4)
2.3
(1.3 to 4.7)
9.Secondary Outcome
Title Comparison of Tumor Necrosis Factor Alpha Values
Hide Description [Not Specified]
Time Frame Baseline and 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Atorvastatin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 31 33
Median (Inter-Quartile Range)
Unit of Measure: ng/mL
Baseline
2.0
(1.2 to 2.9)
1.8
(1.4 to 2.5)
1 month (30 day follow-up)
2.6
(1.7 to 3.8)
1.5
(1.2 to 2.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Atorvastatin
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Placebo Atorvastatin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Atorvastatin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/33 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Atorvastatin
Affected / at Risk (%) Affected / at Risk (%)
Total   26/31 (83.87%)   22/33 (66.67%) 
Cardiac disorders     
Atrial fibrillation *  26/31 (83.87%)  22/33 (66.67%) 
*
Indicates events were collected by non-systematic assessment
Limited enrollment; recurrence rate of AF was slightly higher than other trials indicated that the study sample may be a high-risk population.
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
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 ( Other Identifier: Other )
First Submitted: November 14, 2005
First Posted: November 15, 2005
Results First Submitted: April 21, 2014
Results First Posted: September 3, 2014
Last Update Posted: September 3, 2014