Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (Rosuvastatin) I

Study Overview
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Brief Summary
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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.

Official Title
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Rosuvastatin for Primary Prevention in Acute Aortic Syndrome/Aortic Aneurysm Patients With Low to Average Low-density Lipoprotein Cholesterol Level

Conditions
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Acute Aortic Syndrome, Aortopathy

Intervention / Treatment
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* Drug: Rosuvastatin 10mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Statin<br> | Drug: Rosuvastatin 10mg<br>* Rosuvastatin 10mg is taken by oral or nasal feeding every day at ang time.<br>|
| No Intervention: Blank<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic adverse events | a composite outcomes event of aortic rupture, aortic dissection, severe dilation of the aorta, and cardiac death. | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Death from any cause | 3 months after surgery |