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NCT Number: NCT04699279

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

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.

Recruiting

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Key information

Conditions

Acute Aortic Syndrome Aortic Diseases Aortopathy Cardiovascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rosuvastatin 10mg

Drug

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

Primary outcomes

  1. Aortic adverse events

    Time frame: 3 months after surgery

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

Secondary outcomes

  1. Mortality

    Time frame: 3 months after surgery

    Death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Hong Liu, MD

CONTACT

[email protected]

18801281613

Yong-feng SHAO, MD

CONTACT

[email protected]

18801281613

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

  • Beijing Anzhen Hospital
  • The Affiliated Hospital of Qingdao University Medical College
  • The First Affiliated Hospital of Guangzhou Medical University
  • West China Hospital

Registry information

Acronym: PANDA

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 7, 2021
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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