Protective Effect of Statin Against Negative Cardiovascular Remodeling and Organ Dysfunction After Acute Aortic Syndrome Surgery (PANDA III)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rosuvastatin 10mg.
- Who it may be relevant to
- Registry conditions: Acute Aortic Syndrome, Aortopathy. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Rosuvastatin 10mg
Rosuvastatin 10mg is taken by oral or nasal feeding every day at ang time.
Primary outcome measures
- Aortic adverse events [Time frame: 3 months after surgery]
Secondary outcome measures (1)
- Mortality [Time frame: 3 months after surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
China · 5 centers
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
- The first affiliated hospital of nanjing medical university — Nanjing
- Affiliated Hospital of Qingdao University — Qingdao
- West China Hospital of Sichuan University — Chengdu
- Beijing Anzhen Hospital — Beijing
Identifiers
NCT: NCT04699279 · PANDA III