Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT00756886
• Collaborator: Pfizer (Industry)
• Enrollment: 73
• Location: 1
• Arms: 2
• Duration (Months): 31.9
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arrhythmia	Drug: Atorvastatin; Drug: Placebo	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Atorvastatin 40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.	Drug: Atorvastatin; 40 mg QD 7 day continue after procedure for 14 days
Placebo Comparator: Placebo 40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.	Drug: Placebo; 40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.

Outcome Measures

Primary Outcome Measures

1. Atrial Fibrillation [0-21 days post-operative]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham
• Pfizer

Investigators

• Principal Investigator: Robert J Cerfolio, MD, University of Alabama at Birmingham, Department of Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT00756886
• Other Study ID Numbers: F080722005
• First Posted: Sep 22, 2008
• Last Update Posted: Apr 2, 2013
• Last Verified: Dec 1, 2012

• Additional relevant MeSH terms: Atrial Fibrillation; Atorvastatin

Study Results

Participant Flow

Arm/Group Title	Atorvastatin	Placebo
Arm/Group Description	40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.	40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
Period Title: Overall Study
STARTED	41	32
COMPLETED	30	25
NOT COMPLETED	11	7

Baseline Characteristics

Arm/Group Title	Atorvastatin	Placebo	Total
Arm/Group Description	40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.	40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.	Total of all reporting groups
Overall Participants	41	32	73
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	62	61	61
Sex: Female, Male (Count of Participants)
Female	22 53.7%	15 46.9%	37 50.7%
Male	19 46.3%	17 53.1%	36 49.3%
Region of Enrollment (participants) [Number]
United States	41 100%	32 100%	73 100%

Outcome Measures

1. Primary Outcome

Title	Atrial Fibrillation
Time Frame	0-21 days post-operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Atorvastatin	Placebo
Arm/Group Description	40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.	40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
Measure Participants	30	25
Number [participants]	6 14.6%	1 3.1%

Adverse Events

Arm/Group Title	Atorvastatin		Placebo
Arm/Group Description	40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.		40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery.
All Cause Mortality
	Atorvastatin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Atorvastatin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/30 (36.7%)		3/25 (12%)
Cardiac disorders
Pericarditis	2/30 (6.7%)	2	0/25 (0%)	0
Metabolism and nutrition disorders
Elevated Liver Function Tests	1/30 (3.3%)	1	0/25 (0%)	0
Respiratory, thoracic and mediastinal disorders
Respiratory Distress	2/30 (6.7%)	2	1/25 (4%)	1
Subcutaneous Air	1/30 (3.3%)	1	1/25 (4%)	1
Pneumothorax	1/30 (3.3%)	1	1/25 (4%)	1
Airleak	1/30 (3.3%)	1	0/25 (0%)	0
Chylothorax	1/30 (3.3%)	1	0/25 (0%)	0
Pneumonia	1/30 (3.3%)	1	0/25 (0%)	0
Pulmonary Embolus	1/30 (3.3%)	1	0/25 (0%)	0
Other (Not Including Serious) Adverse Events
	Atorvastatin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	25/30 (83.3%)		17/25 (68%)
Cardiac disorders
Hypotension	9/30 (30%)	9	1/25 (4%)	1
Tachycardia	16/30 (53.3%)	16	11/25 (44%)	11
Hypertension	0/30 (0%)	0	1/25 (4%)	1
Atrial Fibrillation	5/30 (16.7%)	5	1/25 (4%)	1
Non-STEMI Myocardial Infarction	0/30 (0%)	0	1/25 (4%)	1
Elevated Troponin	1/30 (3.3%)	1	0/25 (0%)	0
Gastrointestinal disorders
Constipation	22/30 (73.3%)	22	5/25 (20%)	5
Indigestion	1/30 (3.3%)	1	3/25 (12%)	3
Nausea	12/30 (40%)	12	6/25 (24%)	6
Diarrhea	1/30 (3.3%)	1	2/25 (8%)	2
General disorders
Fever	4/30 (13.3%)	4	3/25 (12%)	3
Insomnia	3/30 (10%)	3	0/25 (0%)	0
Lethargy	2/30 (6.7%)	2	0/25 (0%)	0
Metabolism and nutrition disorders
Anemia	3/30 (10%)	3	0/25 (0%)	0
Electrolyte Imbalance	25/30 (83.3%)	25	17/25 (68%)	17
Hyperglycemia	2/30 (6.7%)	2	2/25 (8%)	2
Musculoskeletal and connective tissue disorders
Muscle Spasms	1/30 (3.3%)	1	4/25 (16%)	4
Nervous system disorders
Tremors	1/30 (3.3%)	1	0/25 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pneumothorax	16/30 (53.3%)	16	14/25 (56%)	14
Airleak	3/30 (10%)	3	7/25 (28%)	7
Dyspnea	4/30 (13.3%)	4	1/25 (4%)	1
Pleural Effusion	8/30 (26.7%)	8	4/25 (16%)	4
Atelectasis	1/30 (3.3%)	1	4/25 (16%)	4
Sub-Q Emphysema	11/30 (36.7%)	11	7/25 (28%)	7
Cough	3/30 (10%)	3	0/25 (0%)	0
Skin and subcutaneous tissue disorders
Itching	7/30 (23.3%)	7	3/25 (12%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.