About this trial
The goal of this clinical trial is to learn whether short-term treatment with atorvastatin can prevent new abnormal rapid heart rhythms after lung surgery in adults aged 60 years or older who are scheduled to have a lung segment or lung lobe removed. The study will also evaluate the safety of short-term atorvastatin treatment around the time of surgery.
The main questions this study aims to answer are:
* Does perioperative atorvastatin lower the number of participants who develop atrial fibrillation or a related rapid rhythm from the upper chambers of the heart during the first 72 hours after surgery? * What medical problems or changes in liver, kidney, or muscle-related laboratory tests occur during treatment?
Participants will be assigned by chance to receive either short-term atorvastatin treatment or a matching placebo-based comparison treatment. A placebo is a look-alike tablet that does not contain atorvastatin. Participants who were already taking a statin (moderate-intensity) before the study will receive a standardized background statin regimen so that their usual treatment is not stopped unnecessarily. Neither the participants nor most members of the research team will know which treatment has been assigned.
Study treatment will usually begin 2 to 7 days before surgery and continue until 72 hours after surgery. After surgery, participants will wear a portable heart monitor continuously for 72 hours to identify abnormal heart rhythms. Researchers will also collect routine clinical information, blood test results, and safety information during the hospital stay and will follow participants for 30 days after surgery.
Eligibility criteria
Qualifiers
Age 60 years or older.
Scheduled to undergo isolated anatomical lung resection, including pulmonary segmentectomy or lobectomy.
Sinus rhythm documented by a preoperative electrocardiogram.
Not receiving antiarrhythmic medication, with the exception of beta-blockers.
Disqualifiers
Untreated hyperthyroidism or hypothyroidism.
History of obstructive hepatobiliary disease, active liver disease, or other serious liver disease.
Preoperative serum creatinine greater than 150 μmol/L.
Known allergy to atorvastatin or another statin, or a history of a serious statin-related adverse reaction, including statin-associated myopathy.
Trial design
Treatments tested in this trial
- Atorvastatin
- Matching Placebo