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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04699279
Acronym
PANDA
Enrollment
300
Registered
2021-01-07
Start date
2021-01-01
Completion date
2024-12-31
Last updated
2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Aortic Syndrome, Aortopathy

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.

Interventions

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

Sponsors

Beijing Anzhen Hospital
CollaboratorOTHER
West China Hospital
CollaboratorOTHER
The First Affiliated Hospital of Guangzhou Medical University
CollaboratorOTHER
The Affiliated Hospital of Qingdao University Medical College
CollaboratorUNKNOWN
Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Aortic adverse events3 months after surgerya composite outcomes event of aortic rupture, aortic dissection, severe dilation of the aorta, and cardiac death.

Secondary

MeasureTime frameDescription
Mortality3 months after surgeryDeath from any cause

Countries

China

Contacts

Primary ContactHong Liu, MD
DR.HONGLIU@FOXMAIL.COM18801281613
Backup ContactYong-feng SHAO, MD
YFSHAOJPH@SINA.COM18801281613

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026