Perioperative Statins to Prevent AFib After Lung Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age60+
SponsorPeking Union Medical College Hospital
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Atorvastatin
DrugAtorvastatin 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.
Matching Placebo
DrugThe matching placebo will be manufactured to resemble the atorvastatin 20-mg tablet in appearance and packaging. Statin-naive participants/Participants receiving long-term low-intensity statin therapy 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.
Treatment groups
540 Participants
are divided into 2 treatment groupsGroup A: Perioperative Atorvastatin 40 mgExperimental treatment 1 intervention
Group B: Placebo-Based ComparatorPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants With New-Onset Postoperative Atrial or Supraventricular Tachyarrhythmia (Postoperative Atrial Fibrillation, POAF)
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.
Time frame
From the end of surgery through 72 hours after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov