Peking Union Medical College Hospital
Beijing, China
Location contact
Shanqing Li
PRINCIPAL_INVESTIGATOR
Tao Lu
CONTACT
Tao Lu
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07727681
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 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.
Trial opening soon.
Get Notified60 year and older
All sexes
Interventional
Phase 4
Beijing, China
Shanqing Li
PRINCIPAL_INVESTIGATOR
Tao Lu
CONTACT
Tao Lu
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Atorvastatin will be administered orally once daily using 20-mg tablets. Participants assigned to the experimental arm will receive atorvastatin 40 mg daily as two 20-mg tablets. Participants who were receiving long-term moderate-intensity statin therapy before enrollment and are assigned to the comparator arm will receive atorvastatin 20 mg daily together with one matching placebo tablet. Treatment will usually begin 2 to 7 days before surgery and continue until 72 hours after surgery.
The matching placebo will be manufactured to resemble the atorvastatin 20-mg tablet in appearance and packaging. Statin-naive participants assigned to the comparator arm will receive two matching placebo tablets orally once daily. Participants receiving long-term moderate-intensity statin therapy before enrollment and assigned to the comparator arm will receive one matching placebo tablet together with atorvastatin 20 mg once daily. Treatment will usually begin 2 to 7 days before surgery and continue until 72 hours after surgery.
Time frame: From the end of surgery through 72 hours after surgery
The number of participants with at least one new electrocardiographically documented episode of atrial fibrillation, atrial flutter, atrial tachycardia, or other supraventricular tachycardia lasting at least 30 seconds. Events will be detected primarily by continuous single-lead Holter monitoring for 72 hours after surgery. Bedside electrocardiographic monitoring and 12-lead electrocardiograms will be used as additional supporting evidence. Each participant will be counted once, regardless of the number of qualifying episodes.
Peking Union Medical College Hospital
Other
Perioperative Statin Therapy for the Prevention of Atrial Fibrillation After Anatomical Lung Resection: A Randomized Controlled Trial
Acronym: STAT-LUNG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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