Trial Outcomes & Findings for Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study (NCT NCT00756886)
NCT ID: NCT00756886
Last Updated: 2013-04-02
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
73 participants
Primary outcome timeframe
0-21 days post-operative
Results posted on
2013-04-02
Participant Flow
Participant milestones
| Measure |
Atorvastatin
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
|
Placebo
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
32
|
|
Overall Study
COMPLETED
|
30
|
25
|
|
Overall Study
NOT COMPLETED
|
11
|
7
|
Reasons for withdrawal
| Measure |
Atorvastatin
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
|
Placebo
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Ineligible
|
9
|
4
|
Baseline Characteristics
Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study
Baseline characteristics by cohort
| Measure |
Atorvastatin
n=41 Participants
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
|
Placebo
n=32 Participants
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
62 years
n=5 Participants
|
61 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
32 participants
n=7 Participants
|
73 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-21 days post-operativeOutcome measures
| Measure |
Atorvastatin
n=30 Participants
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
|
Placebo
n=25 Participants
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
|
|---|---|---|
|
Atrial Fibrillation
|
6 participants
|
1 participants
|
Adverse Events
Atorvastatin
Serious events: 11 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atorvastatin
n=30 participants at risk
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
|
Placebo
n=25 participants at risk
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
6.7%
2/30 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Subcutaneous Air
|
3.3%
1/30 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.3%
1/30 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Elevated Liver Function Tests
|
3.3%
1/30 • Number of events 1
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Airleak
|
3.3%
1/30 • Number of events 1
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
3.3%
1/30 • Number of events 1
|
0.00%
0/25
|
|
Cardiac disorders
Pericarditis
|
6.7%
2/30 • Number of events 2
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.3%
1/30 • Number of events 1
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolus
|
3.3%
1/30 • Number of events 1
|
0.00%
0/25
|
Other adverse events
| Measure |
Atorvastatin
n=30 participants at risk
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
|
Placebo
n=25 participants at risk
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
|
|---|---|---|
|
Cardiac disorders
Hypotension
|
30.0%
9/30 • Number of events 9
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Anemia
|
10.0%
3/30 • Number of events 3
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
53.3%
16/30 • Number of events 16
|
56.0%
14/25 • Number of events 14
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
83.3%
25/30 • Number of events 25
|
68.0%
17/25 • Number of events 17
|
|
Respiratory, thoracic and mediastinal disorders
Airleak
|
10.0%
3/30 • Number of events 3
|
28.0%
7/25 • Number of events 7
|
|
Cardiac disorders
Tachycardia
|
53.3%
16/30 • Number of events 16
|
44.0%
11/25 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.3%
4/30 • Number of events 4
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
73.3%
22/30 • Number of events 22
|
20.0%
5/25 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
26.7%
8/30 • Number of events 8
|
16.0%
4/25 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
3.3%
1/30 • Number of events 1
|
16.0%
4/25 • Number of events 4
|
|
Gastrointestinal disorders
Indigestion
|
3.3%
1/30 • Number of events 1
|
12.0%
3/25 • Number of events 3
|
|
Cardiac disorders
Hypertension
|
0.00%
0/30
|
4.0%
1/25 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
2/30 • Number of events 2
|
8.0%
2/25 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
3.3%
1/30 • Number of events 1
|
16.0%
4/25 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Itching
|
23.3%
7/30 • Number of events 7
|
12.0%
3/25 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
40.0%
12/30 • Number of events 12
|
24.0%
6/25 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Sub-Q Emphysema
|
36.7%
11/30 • Number of events 11
|
28.0%
7/25 • Number of events 7
|
|
Cardiac disorders
Atrial Fibrillation
|
16.7%
5/30 • Number of events 5
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Fever
|
13.3%
4/30 • Number of events 4
|
12.0%
3/25 • Number of events 3
|
|
Cardiac disorders
Non-STEMI Myocardial Infarction
|
0.00%
0/30
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
Elevated Troponin
|
3.3%
1/30 • Number of events 1
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
3/30 • Number of events 3
|
0.00%
0/25
|
|
General disorders
Insomnia
|
10.0%
3/30 • Number of events 3
|
0.00%
0/25
|
|
Nervous system disorders
Tremors
|
3.3%
1/30 • Number of events 1
|
0.00%
0/25
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • Number of events 1
|
8.0%
2/25 • Number of events 2
|
|
General disorders
Lethargy
|
6.7%
2/30 • Number of events 2
|
0.00%
0/25
|
Additional Information
Ayesha S. Bryant, MD
Surgery - Cardiovascular/Thoracic
Phone: (205) 996-7561
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place