Protective Effect of Statin Against Negative Cardiovascular Remodeling and Organ Dysfunction After Acute Aortic Syndrome Surgery (PANDA III)

NCT04699279 | Recruiting DMC

• 1 other identifier: PANDA III
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 5

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.

Conditions

Acute Aortic Syndrome; Aortopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mortality

  3 months after surgery

Study Arms (2)

Statin

EXPERIMENTAL

Drug: Rosuvastatin 10mg

Blank

NO INTERVENTION

Interventions

Rosuvastatin 10mg DRUG

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

Statin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Nanjing Medical University: lead
• Beijing Anzhen Hospital: collaborator
• West China Hospital: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• The Affiliated Hospital of Qingdao University Medical College: collaborator

Study Sites (5)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

The first affiliated hospital of nanjing medical university

Nanjing, Jiangsu, 210029, China

RECRUITING

Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

Beijing Anzhen Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Acute Aortic Syndrome

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Aortic Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Hong Liu, MD

CONTACT

18801281613; DR.HONGLIU@FOXMAIL.COM

Yong-feng SHAO, MD

CONTACT

18801281613; YFSHAOJPH@SINA.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Cardiovascular surgery Dept.

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 7, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

CN (5)