Postoperative Atrial FibrillationPhase 4STAT-LUNGNCT07727681
Perioperative Statins to Prevent AFib After Lung Surgery
A Phase 4 study testing Atorvastatin in people with Postoperative Atrial Fibrillation and Lung Surgery, run by Peking Union Medical College Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Atrial Fibrillation, Lung Surgery
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2026to 2 Jan 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Peking Union Medical College Hospital
Beijing
Tao Lu, 01069152630, lutaowhiz@sina.com
Tao Lu
- Recruiting
Peking Union Medical College Hospital
Beijing
Tao Lu, 01069152630, lutaowhiz@sina.com
Tao Lu, MD, PhD
About this study
Official title: Perioperative Statin Therapy for the Prevention of Atrial Fibrillation After Anatomical Lung Resection: A Randomized Controlled 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:
Read more
- 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
- Being tested
- Atorvastatin, Matching Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
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.
Matching PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Perioperative Atorvastatin 40 mg | Experimental | Participants will receive atorvastatin 40 mg orally once daily, administered as two 20-mg tablets. Treatment will usually begin 2 to 7 days before surgery and continue until 72 hours after surgery. Receives: Drug: Atorvastatin |
| Placebo-Based Comparator | Placebo comparator | Statin-naive participants/Participants receiving long-term low-intensity statin therapy will receive two matching placebo tablets orally once daily. Participants receiving long-term moderate-intensity statin therapy before enrollment will receive atorvastatin 20 mg plus one matching placebo tablet once daily. Treatment will usually begin 2 to 7 days before surgery and continue until 72 hours after surgery. Receives: Drug: Atorvastatin; Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the end of surgery through 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion2 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Tao, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727681
- Sponsor's protocol ID
- K11213
- Other IDs
- 2026-PUMCH-A-090
- Acronym
- STAT-LUNG
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Statin Therapy for the Prevention of Atrial Fibrillation After Anatomical Lung Resection: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07727681
- Acronym / sponsor ID
- STAT-LUNG / K11213
- Conditions
- Postoperative Atrial Fibrillation, Lung Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 2 Jan 2028 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perioperative Atorvastatin 40 mg | Experimental | Drug: AtorvastatinParticipants will receive atorvastatin 40 mg orally once daily, administered as two 20-mg tablets. Treatment will usually begin 2 to 7 days before surgery and continue until 72 hours after surgery. |
| Placebo-Based Comparator | Placebo comparator | Drug: Atorvastatin, Drug: Matching PlaceboStatin-naive participants/Participants receiving long-term low-intensity statin therapy will receive two matching placebo tablets orally once daily. Participants receiving long-term moderate-intensity statin therapy before enrollment will receive atorvastatin 20 mg plus one matching placebo tablet once daily. Treatment will usually begin 2 to 7 days before surgery and continue until 72 hours after surgery. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAtorvastatin 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 | Perioperative Atorvastatin 40 mg, Placebo-Based Comparator |
| Matching PlaceboThe 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. | Drug | Placebo-Based Comparator |
Primary outcome
Number of Participants With New-Onset Postoperative Atrial or Supraventricular Tachyarrhythmia (Postoperative Atrial Fibrillation, POAF)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin in people with Postoperative Atrial Fibrillation and Lung Surgery, run by Peking Union Medical College Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Lu, MD,PhD (01069152630, lutaowhiz@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With New-Onset Postoperative Atrial or Supraventricular Tachyarrhythmia (Postoperative Atrial Fibrillation, POAF) (time frame: From the end of surgery through 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.