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

N

Nanjing Medical University

Status

Enrolling

Conditions

Acute Aortic Syndrome
Aortopathy

Treatments

Drug: Rosuvastatin 10mg

Study type

Interventional

Funder types

Other

Identifiers

NCT04699279
PANDA III

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

300 participants in 2 patient groups

Statin
Experimental group
Treatment:
Drug: Rosuvastatin 10mg
Blank
No Intervention group

Trial contacts and locations

5

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Central trial contact

Hong Liu, MD; Yong-feng SHAO, MD

Data sourced from clinicaltrials.gov

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