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

Not Applicable

Recruiting

• Conditions: Acute Aortic Syndrome; Aortopathy
• Interventions: Drug: Rosuvastatin 10mg

• Registration Number: NCT04699279
• Lead Sponsor: Nanjing Medical University

Brief Summary

Acute Aortic Syndrome (AAS)/Aortic Aneurysm is a common feature of aortic wall events, including aortic dissection, intramural hematoma, aortic ulceration and aortic trauma, and occurs in up to 35 cases per 100,000 cases per year between the ages of 65 and 75 years. Increased levels of the inflammatory biomarker high-sensitivity C-reactive protein predict cardiovascular events. Since statins lower levels of high-sensitivity C-reactive protein as well as cholesterol, the authors hypothesized that people with acute aortic syndrome but without hyperlipidemia might benefit from statin treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Statin	Rosuvastatin 10mg	-

Primary Outcome Measures

Name	Time	Method
Aortic adverse events	3 months after surgery	a composite outcomes event of aortic rupture, aortic dissection, severe dilation of the aorta, and cardiac death.

Secondary Outcome Measures

Name	Time	Method
Mortality	3 months after surgery	Death from any cause

Trial Locations

Locations (5)

The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

The first affiliated hospital of nanjing medical university; 🇨🇳 Nanjing, Jiangsu, China

Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Beijing Anzhen Hospital; 🇨🇳 Beijing, China