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

Acute Aortic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04699279
• Other study ID #: 5A-Plan I
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2021
• Source: Nanjing Medical University
• Contact: Hong Liu, MD
• Phone: 18801281613
• Email: DR.HONGLIU[@]FOXMAIL.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Aortic Syndrome
• Aortopathy
• Syndrome

Intervention

Drug:
• Rosuvastatin 10mg
Rosuvastatin 10mg is taken by oral or nasal feeding every day at ang time.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing
China	The first affiliated hospital of nanjing medical university	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Nanjing Medical University	Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality	Death from any cause	3 months after surgery