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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin | Active Comparator | 40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery. |
|
| Placebo | Placebo Comparator | 40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | 40 mg QD 7 day continue after procedure for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial Fibrillation | 0-21 days post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert J Cerfolio, MD | University of Alabama at Birmingham, Department of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin | 40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery. |
| FG001 | Placebo | 40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin | 40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery. |
| BG001 | Placebo | 40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Atrial Fibrillation | Posted | Number | participants | 0-21 days post-operative |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atorvastatin | 40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ayesha S. Bryant, MD | Surgery - Cardiovascular/Thoracic | (205) 996-7561 | abryant@uab.edu |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo |
| Drug |
40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery. |
|
| Lack of Efficacy |
|
| Ineligible |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 11 |
| 30 |
| 25 |
| 30 |
| EG001 | Placebo | 40 mg QD for 7 days prior to surgery, and then continue at same dosage for 14 days after surgery. | 3 | 25 | 17 | 25 |
| Subcutaneous Air | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Elevated Liver Function Tests | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Airleak | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Chylothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pericarditis | Cardiac disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary Embolus | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Anemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Electrolyte Imbalance | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Airleak | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Indigestion | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hypertension | Cardiac disorders | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Sub-Q Emphysema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Fever | General disorders | Non-systematic Assessment |
|
| Non-STEMI Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
|
| Elevated Troponin | Cardiac disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Insomnia | General disorders | Non-systematic Assessment |
|
| Tremors | Nervous system disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Lethargy | General disorders | Non-systematic Assessment |
|
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| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |