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

Sponsor

Nanjing Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04699279

Collaborator

Beijing Anzhen Hospital (Other)

300

Enrollment

Locations

Arms

35.9

Anticipated Duration (Months)

150

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Aortic Syndrome Aortopathy	Drug: Rosuvastatin 10mg	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Aortic adverse events [3 months after surgery]
a composite outcomes event of aortic rupture, aortic dissection, severe dilation of the aorta, and cardiac death.

Secondary Outcome Measures

Mortality [3 months after surgery]
Death from any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The first affiliated hospital of nanjing medical university	Nanjing	Jiangsu	China	210029
2	Beijing Anzhen Hospital	Beijing		China

Sponsors and Collaborators

Nanjing Medical University
Beijing Anzhen Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hong Liu, Principal Investigator of Cardiovascular surgery Dept., Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT04699279

Other Study ID Numbers:

5A-Plan I

First Posted:

Jan 7, 2021

Last Update Posted:

Jul 30, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Syndrome

Rosuvastatin Calcium

Study Results

No Results Posted as of Jul 30, 2021