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Perioperative Statins to Prevent AFib After Lung Surgery

NCT07727681 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2026-07-28

No results posted yet for this study

Summary

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.

Conditions

  • Postoperative Atrial Fibrillation
  • Lung Surgery

Interventions

DRUG

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.

DRUG

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. Treatment will usually begin 2 to 7 days before surgery and continue until 72 hours after surgery.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-09-01
Completion
2028-01-02

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07727681 on ClinicalTrials.gov