Perioperative Statins to Prevent AFib After Lung Surgery

Официальное название

Perioperative Statin Therapy for the Prevention of Atrial Fibrillation After Anatomical Lung Resection: A Randomized Controlled Trial

Обзор

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.

Вмешательства

• Препарат Atorvastatin
  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.
• Препарат Matching Placebo
  The 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. T

Первичные конечные точки

• Number of Participants With New-Onset Postoperative Atrial or Supraventricular Tachyarrhythmia (Postoperative Atrial Fibrillation, POAF) [Срок оценки: From the end of surgery through 72 hours after surgery]

Критерии участия

Критерии включения

• 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.
• Willing and able to provide written informed consent.

Критерии исключения

• 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.
• Personal or family history of an inherited muscle disorder.
• Continuous use within 1 month before randomization of fibrates, niacin, or medications that strongly inhibit cytochrome P450 or P-glycoprotein, including cyclosporine, oral azole antifungal agents, certain interacting antibiotics, protease inhibitors, nefazodone, or amiodarone.
• Consumption of 1 liter or more of grapefruit juice per day within 1 month before randomization.
• Current treatment with a high-intensity statin regimen, including atorvastatin 40 mg/day or higher or rosuvastatin 20 mg/day or higher.
• Any other condition that, in the investigator's judgment, would make participation unsafe or interfere with the conduct or evaluation of the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Китай · 2 центра

• Peking Union Medical College Hospital — Пекин
• Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT07727681 · K11213 · 2026-PUMCH-A-090

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗