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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Aortic Syndrome; Aortopathy
• Intervention / Treatment: Drug: Rosuvastatin 10mg

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yong-feng SHAO, MD; Phone Number: 18801281613; Email: YFSHAOJPH@SINA.COM

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Anzhen Hospital
    • Contact: Si-chong Qian, MD; Phone Number: 13120130755; Email: drqsc1990a@163.com
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanjing Medical University
• Collaborators: Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 30, 2021
• Last Update Submitted That Met QC Criteria: July 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: 5A-Plan I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No