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

Primary Purpose

Acute Aortic Syndrome, Aortopathy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rosuvastatin 10mg
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Aortic Syndrome

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The first affiliated hospital of nanjing medical universityRecruiting
  • Beijing Anzhen HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Statin

Blank

Arm Description

Outcomes

Primary Outcome Measures

Aortic adverse events
a composite outcomes event of aortic rupture, aortic dissection, severe dilation of the aorta, and cardiac death.

Secondary Outcome Measures

Mortality
Death from any cause

Full Information

First Posted
January 6, 2021
Last Updated
July 23, 2021
Sponsor
Nanjing Medical University
Collaborators
Beijing Anzhen Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04699279
Brief Title
Additive Anti-inflammatory Action for Aortopathy & Arteriopathy (Rosuvastatin) I
Official Title
Rosuvastatin for Primary Prevention in Acute Aortic Syndrome/Aortic Aneurysm Patients With Low to Average Low-density Lipoprotein Cholesterol Level
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University
Collaborators
Beijing Anzhen Hospital

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Aortic Syndrome, Aortopathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Statin
Arm Type
Experimental
Arm Title
Blank
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 10mg
Intervention Description
Rosuvastatin 10mg is taken by oral or nasal feeding every day at ang time.
Primary Outcome Measure Information:
Title
Aortic adverse events
Description
a composite outcomes event of aortic rupture, aortic dissection, severe dilation of the aorta, and cardiac death.
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
Mortality
Description
Death from any cause
Time Frame
3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Liu, MD
Phone
18801281613
Email
DR.HONGLIU@FOXMAIL.COM
First Name & Middle Initial & Last Name or Official Title & Degree
Yong-feng SHAO, MD
Phone
18801281613
Email
YFSHAOJPH@SINA.COM
Facility Information:
Facility Name
The first affiliated hospital of nanjing medical university
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Liu, MD
Phone
188012181613
Email
dr.hongliu@foxmail.com
Facility Name
Beijing Anzhen Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Si-chong Qian, MD
Phone
13120130755
Email
drqsc1990a@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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