Clinical trial NCT04699279: Protective Effect of Statin Against Negative Cardiovascular Remodeling and Organ Dysfunction After Acute Aortic Syndrome Surgery (PANDA III)
Official title: Protective Effect of Statin Against Negative Cardiovascular Remodeling and Organ Dysfunction After Acute Aortic Syndrome Surgery (PANDA III)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Aortic Syndrome
Aortopathy
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Anzhen Hospital
name: West China Hospital
name: The First Affiliated Hospital of Guangzhou Medical University
name: The Affiliated Hospital of Qingdao University Medical College
First posted: 2021-01-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Aortic adverse events
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Mortality
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Nanjing
country: China
facility: The first affiliated hospital of nanjing medical university
state: Jiangsu
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University
state: Shandong
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Beijing
country: China
facility: Beijing Anzhen Hospital
Study officials:
References: