N/A
N=162
Study of Atorvastatin Versus Placebo to Reduce Cardiopulmonary Complications After Thoracic Surgery
Thoracic Surgery
Bottom Line
View on ClinicalTrials.gov: NCT00375518 ↗Enrolled (actual)
162
Serious AEs
1.2%
Results posted
Jan 2016
Primary outcome: Primary: Determine the Postoperative Complications Found in Each Group — 16; 8; 56; 57 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Atorvastatin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determine the Postoperative Complications Found in Each Group |
16; 8; 56; 57 | — |
Summary
This study will compare atorvastatin (Lipitor) with a placebo (inactive pill) to see if this drug reduces heart rhythm abnormalities (arrhythmias) or lung inflammation after thoracic surgery. Preliminary results suggest that cholesterol lowering drugs (statins) may reduce problems after surgery such as arrhythmias or lung inflammation which may be serious. This study will be randomized and double blind, meaning that patients are placed in groups purely by chance, like flipping a coin. Neither the patient or doctor will know which group the patient is in.
Eligibility Criteria
Inclusion Criteria
- Adult patients ≥ 18 yr. scheduled for anatomic lung resection (segmentectomy, lingulectomy, possible or definite lobectomy, bilobectomy, pneumonectomy or extrapleural pneumonectomy) with or without chest wall resection or limited resection
- Patients with regular cardiac rhythm
- Patients able to take oral capsules
- Patients capable of providing written, informed consent
- Patients without known hepatic or kidney disease
Exclusion Criteria
- Patients already taking any statin, gemfibrozil (Lopid), or ezetimibe (Zetia)
- Hypersensitivity to atorvastatin
- Chronic atrial fibrillation
- Patients already taking class Ic or III antiarrhythmic drugs
- Known pregnancy a urine pregnancy test will be given to women of childbearing age
- Known history of active hepatic disease or known hepatic insufficiency
- Known history of active kidney disease or insufficiency
Data sourced from ClinicalTrials.gov (NCT00375518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.