Using statins to protect heart health after aortic surgery

Protective Effect of Statin Against Negative Cardiovascular Remodeling and Organ Dysfunction After Acute Aortic Syndrome Surgery (PANDA III)

This study tests if the cholesterol-lowering drug rosuvastatin can help people recover better and protect their heart health after surgery for serious aortic problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Nanjing Medical University (Academic / other)
• Locations: 5 sites (Guangzhou, Guangdong and 4 other locations)
• Trial ID: NCT04699279 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the protective effects of the statin rosuvastatin in patients who have undergone surgery for acute aortic syndrome, such as aortic dissection or aneurysm. The study focuses on individuals without significant hyperlipidemia but with cardiovascular risk factors, hypothesizing that statins can reduce inflammation and improve cardiovascular outcomes. Participants will receive a daily dose of 10mg rosuvastatin and will be monitored for improvements in cardiovascular health post-surgery.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 85 with aortic dissection or related conditions who have cardiovascular risk factors but do not have clinically significant hyperlipidemia.

Not a fit: Patients with allergies to statins, active liver disease, myopathy, or those who are pregnant or lactating may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve heart health and reduce complications for patients recovering from acute aortic syndrome surgery.

How similar studies have performed: While the use of statins in cardiovascular health is well-studied, this specific application in acute aortic syndrome is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* (1) Patients with aortic dissection/ulceration/intermural hematoma/aortic aneurysm who underwent aortic arch replacement or endoluminal isolation or hybrid therapy;
* (2) Paitents without clinically significant hyperlipidemia but with cardiovascular disease risk factors (such as male ≥45 years old, female ≥55 years old, hypertension, diabetes, chronic kidney disease, obesity, low HDL cholesterol, smoking, alcohol consumption, family history of early onset ischemic cardiovascular disease) and no previous use of statins;
* (3) Patients are between 18 and 85 years old, male or female;
* (4) Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

* (1) Patients with allergy to statins;
* (2) patients with active liver disease;
* (3) patients with myopathy;
* (4) Lactating women and pregnant women;
* (5) Patients with mental diseases, drug and alcohol dependence;
* (6) Refuse to participate in the study or sign the informed consent.

Where this trial is running

Guangzhou, Guangdong and 4 other locations

• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
• The first affiliated hospital of nanjing medical university — Nanjing, Jiangsu, China (Recruiting)
• Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
• Beijing Anzhen Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Hong Liu, MD

Conditions Acute Aortic Syndrome; Aortopathy