Trial Outcomes & Findings for Atorvastatin Therapy for the Prevention of Atrial Fibrillation (SToP-AF) (NCT NCT00252967)
NCT ID: NCT00252967
Last Updated: 2014-09-03
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
64 participants
Primary outcome timeframe
Upon recurrence, up to 12 months
Results posted on
2014-09-03
Participant Flow
Participant milestones
| Measure |
Placebo
|
Atorvastatin
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
33
|
|
Overall Study
COMPLETED
|
31
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Atorvastatin Therapy for the Prevention of Atrial Fibrillation (SToP-AF)
Baseline characteristics by cohort
| Measure |
Placebo
n=31 Participants
|
Atorvastatin
n=33 Participants
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 13.9 • n=99 Participants
|
58.2 years
STANDARD_DEVIATION 11.6 • n=107 Participants
|
58.5 years
STANDARD_DEVIATION 12.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Upon recurrence, up to 12 monthsOutcome measures
| Measure |
Placebo
n=31 Participants
|
Atorvastatin
n=33 Participants
|
|---|---|---|
|
Time of Atrial Fibrillation Recurrence
|
22 days
Interval 7.0 to 70.0
|
29 days
Interval 2.0 to 145.0
|
SECONDARY outcome
Timeframe: Baseline and 30 daysOutcome measures
| Measure |
Placebo
n=31 Participants
|
Atorvastatin
n=33 Participants
|
|---|---|---|
|
Comparison of Redox Potential for Cysteine Values
Baseline
|
-61.2 mV
Interval -71.2 to -54.8
|
-65.3 mV
Interval -71.3 to -58.8
|
|
Comparison of Redox Potential for Cysteine Values
1 month (30 day follow-up)
|
-64.5 mV
Interval -69.8 to -58.5
|
-62.6 mV
Interval -68.0 to -58.0
|
SECONDARY outcome
Timeframe: Baseline and 30 daysOutcome measures
| Measure |
Placebo
n=31 Participants
|
Atorvastatin
n=33 Participants
|
|---|---|---|
|
Comparison of Redox Potential for Glutathione Values
Baseline
|
-116.7 mV
Interval -134.9 to -110.2
|
-125.3 mV
Interval -138.0 to -117.3
|
|
Comparison of Redox Potential for Glutathione Values
1 month (30 day follow-up)
|
-124.3 mV
Interval -142.1 to -109.0
|
-129.0 mV
Interval -138.2 to -113.4
|
SECONDARY outcome
Timeframe: Baseline and 30 daysOutcome measures
| Measure |
Placebo
n=31 Participants
|
Atorvastatin
n=33 Participants
|
|---|---|---|
|
Comparison of Derivatives of Reactive Oxygen Metabolites Values
Baseline
|
384 Carr
Interval 276.0 to 422.0
|
382 Carr
Interval 322.0 to 467.0
|
|
Comparison of Derivatives of Reactive Oxygen Metabolites Values
1 month (30 day follow-up)
|
400 Carr
Interval 338.0 to 450.0
|
345 Carr
Interval 304.0 to 406.0
|
SECONDARY outcome
Timeframe: Baseline and 30 daysOutcome measures
| Measure |
Placebo
n=31 Participants
|
Atorvastatin
n=33 Participants
|
|---|---|---|
|
Comparison of Isoprostanes Values
Baseline
|
1259 pg/mL
Interval 1040.0 to 1738.0
|
1062 pg/mL
Interval 817.0 to 1421.0
|
|
Comparison of Isoprostanes Values
1 month (30 day follow-up)
|
1146 pg/mL
Interval 964.0 to 1397.0
|
1240 pg/mL
Interval 953.0 to 1397.0
|
SECONDARY outcome
Timeframe: Baseline and 30 daysOutcome measures
| Measure |
Placebo
n=31 Participants
|
Atorvastatin
n=33 Participants
|
|---|---|---|
|
Comparison of Interleukin-6 Values
Baseline
|
5.3 ng/mL
Interval 2.1 to 9.2
|
4.0 ng/mL
Interval 1.7 to 6.6
|
|
Comparison of Interleukin-6 Values
1 month (30 day follow-up)
|
5.6 ng/mL
Interval 3.2 to 8.6
|
2.2 ng/mL
Interval 1.7 to 3.6
|
SECONDARY outcome
Timeframe: Baseline and 30 daysOutcome measures
| Measure |
Placebo
n=31 Participants
|
Atorvastatin
n=33 Participants
|
|---|---|---|
|
Comparison of Interleukin-1 Values
Baseline
|
0.29 ng/mL
Interval 0.2 to 0.44
|
0.30 ng/mL
Interval 0.17 to 0.47
|
|
Comparison of Interleukin-1 Values
1 month (30 day follow-up)
|
0.25 ng/mL
Interval 0.17 to 0.32
|
0.28 ng/mL
Interval 0.21 to 0.32
|
SECONDARY outcome
Timeframe: Baseline and 30 daysOutcome measures
| Measure |
Placebo
n=31 Participants
|
Atorvastatin
n=33 Participants
|
|---|---|---|
|
Comparison of High Sensitivity C-reactive Protein
Baseline
|
9.6 mg/L
Interval 1.7 to 15.0
|
6.3 mg/L
Interval 2.2 to 11.8
|
|
Comparison of High Sensitivity C-reactive Protein
1 month (30 day follow-up)
|
12.3 mg/L
Interval 2.8 to 14.4
|
2.3 mg/L
Interval 1.3 to 4.7
|
SECONDARY outcome
Timeframe: Baseline and 30 daysOutcome measures
| Measure |
Placebo
n=31 Participants
|
Atorvastatin
n=33 Participants
|
|---|---|---|
|
Comparison of Tumor Necrosis Factor Alpha Values
Baseline
|
2.0 ng/mL
Interval 1.2 to 2.9
|
1.8 ng/mL
Interval 1.4 to 2.5
|
|
Comparison of Tumor Necrosis Factor Alpha Values
1 month (30 day follow-up)
|
2.6 ng/mL
Interval 1.7 to 3.8
|
1.5 ng/mL
Interval 1.2 to 2.9
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Atorvastatin
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=31 participants at risk
|
Atorvastatin
n=33 participants at risk
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
83.9%
26/31
|
66.7%
22/33
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place