NCT07727681 Perioperative Statins to Prevent AFib After Lung Surgery
| NCT ID | NCT07727681 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Postoperative Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 540 participants |
| Start Date | 2026-08-01 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 540 participants in total. It began in 2026-08-01 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07727681 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Postoperative Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07727681 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07727681 currently recruiting?
Yes, NCT07727681 is actively recruiting participants. Contact the research team at lutaowhiz@sina.com for enrollment information.
Where is the NCT07727681 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT07727681 clinical trial?
NCT07727681 is sponsored by Peking Union Medical College Hospital. The trial plans to enroll 540 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.