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

December 10, 2024 updated by: Hong Liu, Nanjing Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Anzhen Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Ying-yuan Zhang, MD
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:
    • Shandong
      • Qingdao, Shandong, China
        • Recruiting
        • Affiliated Hospital of Qingdao University
        • Contact:
        • Contact:
          • Ji-nong Yang, MD
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Hong-hua Yue, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Statin
Drug: Rosuvastatin 10mg
Rosuvastatin 10mg is taken by oral or nasal feeding every day at ang time.
No Intervention: Blank

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 3 months after surgery
Death from any cause
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 6, 2021

First Submitted That Met QC Criteria

January 6, 2021

First Posted (Actual)

January 7, 2021

Study Record Updates

Last Update Posted (Actual)

December 13, 2024

Last Update Submitted That Met QC Criteria

December 10, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANDA III

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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