Arrhythmia
Conditions
Brief summary
The purpose of this study is to determine if atorvastatin (Lipitor) reduces the occurence of abnormal heart rhythm (atrial arrhythmia) following non cardiac thoracic surgery.
Detailed description
The incidence of atrial arrhythmia after thoracic, non-cardiac procedures is exceedingly common and has been reported to occur in between 10-39% of patients. It has been shown to increase majority morbidity and also delay hospital discharge. Recent studies suggest that one week of pre-operative atorvastatin may reduce the incidence of post-operative atrial arrhythmia in patients who undergo cardiac surgery and a multi-institutional study is currently underway to further examine this concept. However, there are no published prospective randomized studies to date that have evaluated the effectiveness of atorvastatin to reduce atrial arrhythmia in patients who undergo thoracic, non-cardiac operations such as esophagectomy or pulmonary resection. The object of this study is to determine if atorvastatin reduces the incidence of atrial arrhythmia (atrial fibrillation or flutter) following non-cardiac thoracic surgery, specifically pulmonary resections.
Interventions
DRUGAtorvastatin
40 mg QD 7 day continue after procedure for 14 days
DRUGPlacebo
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
Sponsors
Pfizer
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients scheduled for elective non-cardiac thoracic surgery requiring thoracotomy for resection
Exclusion criteria
* Past medical history of pacemaker implantation * Pregnancy or lactating * History of Atrial arrhythmia within the past year * Elevated liver enzymes pre-operatively * Past medical history of any liver disease or history of liver transplantation * Use of statins or any anti-arrhythmics (including beta-blockers, calcium channel blockers, digoxin) within 3 months prior to surgery * Pre-op EKG showing atrial arrhythmia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atrial Fibrillation | 0-21 days post-operative |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Atorvastatin 40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery. | 41 |
| Placebo 40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery. | 32 |
| Total | 73 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 |
| Overall Study | Ineligible | 9 | 4 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Atorvastatin | Placebo | Total |
|---|---|---|---|
| Age Continuous | 62 years | 61 years | 61 years |
| Region of Enrollment United States | 41 participants | 32 participants | 73 participants |
| Sex: Female, Male Female | 22 Participants | 15 Participants | 37 Participants |
| Sex: Female, Male Male | 19 Participants | 17 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 30 | 17 / 25 |
| serious Total, serious adverse events | 11 / 30 | 3 / 25 |
Outcome results
Primary
Atrial Fibrillation
Time frame: 0-21 days post-operative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Atorvastatin | Atrial Fibrillation | 6 participants |
| Placebo | Atrial Fibrillation | 1 participants |