Actively Recruiting
Protective Effect of Statin Against Negative Cardiovascular Remodeling and Organ Dysfunction After Acute Aortic Syndrome Surgery (PANDA III)
Led by Nanjing Medical University · Updated on 2024-12-13
300
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Nanjing Medical University
Lead Sponsor
B
Beijing Anzhen Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Acute Aortic Syndrome (AAS) and Aortic Aneurysm involve serious aortic wall conditions such as aortic dissection, intramural hematoma, ulceration, and trauma, mostly affecting people aged 65 to 75 years. Elevated levels of the inflammatory marker high-sensitivity C-reactive protein are linked to cardiovascular events. Researchers are studying whether statins can help people with AAS who do not have high cholesterol but have other cardiovascular risk factors. The trial compares the use of Rosuvastatin 10mg taken daily by mouth or nasal feeding with no intervention after surgery for acute aortic syndrome. Participants receive either the statin treatment or no treatment following aortic arch replacement, endoluminal isolation, or hybrid therapy. The study uses a randomized, triple-blind design to assess the effects of statin treatment on cardiovascular health after surgery. Participants will be monitored for aortic adverse events and mortality three months after surgery. The study involves consent, regular follow-up, and evaluation of cardiovascular and organ function outcomes. Researchers will measure the occurrence of complications and survival rates to understand the protective effects of statins in this group. The study includes adults aged 18 to 85 years without significant hyperlipidemia but with cardiovascular risk factors.
CONDITIONS
Brief Title
Protective Effect of Statin Against Negative Cardiovascular Remodeling and Organ Dysfunction After Acute Aortic Syndrome Surgery (PANDA III)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with aortic dissection, ulceration, intramural hematoma, or aortic aneurysm who have undergone aortic arch replacement, endoluminal isolation, or hybrid therapy
- Patients without clinically significant hyperlipidemia but with cardiovascular risk factors such as male aged 45 or older, female aged 55 or older, hypertension, diabetes, chronic kidney disease, obesity, low HDL cholesterol, smoking, alcohol use, or family history of early ischemic cardiovascular disease
- Patients aged between 18 and 85 years, male or female
- Patients who agree to participate and sign informed consent
You will not qualify if you...
- Allergy to statins
- Active liver disease
- Myopathy
- Pregnant or breastfeeding women
- Mental illness or drug and alcohol dependence
- Refusal to participate or sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - 3 months after surgery
Participants receive Rosuvastatin 10mg daily to prevent negative cardiovascular remodeling and organ dysfunction following acute aortic syndrome surgery.
Regular visits during the 3 months treatment period
Trial Site Locations
Total: 5 locations
1
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Actively Recruiting
2
The first affiliated hospital of nanjing medical university
Nanjing, Jiangsu, China, 210029
Actively Recruiting
3
Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Actively Recruiting
4
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
5
Beijing Anzhen Hospital
Beijing, China
Actively Recruiting
Research Team
H
Hong Liu, MD
Y
Yong-feng SHAO, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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