Acute Aortic SyndromePANDANCT04699279
Protective Effect of Statin Against Negative Cardiovascular Remodeling and Organ Dysfunction After Acute Aortic Syndrome Surgery (PANDA III)
A study testing Rosuvastatin 10mg in people with Acute Aortic Syndrome and Aortopathy, run by Nanjing Medical University at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Aortic Syndrome, Aortopathy
- What is being tested?
- Rosuvastatin 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jan 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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 locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing
Si-chong Qian, MD, 13120130755, drqsc1990a@163.com
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Hong-hua Yue, MD, 13281130798, yuecqmu@163.com
Hong-hua Yue, MD
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Ying-yuan Zhang, MD, 13662378847@139.com
Ying-yuan Zhang, MD
- Recruiting
The first affiliated hospital of nanjing medical university
Nanjing, Jiangsu, 210029
Hong Liu, MD, 188012181613, dr.hongliu@foxmail.com
- Recruiting
Affiliated Hospital of Qingdao University
Qingdao, Shandong
Ji-nong Yang, MD, 8618661855609, yangjn2008@163.com
Ji-nong Yang, MD
About this study
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
- Being tested
- Rosuvastatin 10mg
- Medical subject headings
- Acute Aortic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 10mgDrug
Rosuvastatin 10mg is taken by oral or nasal feeding every day at ang time.
| Study group | Role | What they receive |
|---|---|---|
| Statin | Experimental | Not described Receives: Drug: Rosuvastatin 10mg |
| Blank | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic adverse events
a composite outcomes event of aortic rupture, aortic dissection, severe dilation of the aorta, and cardiac death.
Measured: 3 months after surgery
Secondary outcomes (1)
Mortality
Death from any cause
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Aortic SyndromeStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Anzhen Hospital, West China Hospital, The First Affiliated Hospital of Guangzhou Medical University, The Affiliated Hospital of Qingdao University Medical College
- Responsible party
- Principal investigator, Hong Liu, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699279
- Sponsor's protocol ID
- PANDA III
- Acronym
- PANDA
- Status last verified
- Dec 2024
- First submitted
- 6 Jan 2021
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effect of Statin Against Negative Cardiovascular Remodeling and Organ Dysfunction After Acute Aortic Syndrome Surgery (PANDA III)
- ClinicalTrials.gov ID
- NCT04699279
- Acronym / sponsor ID
- PANDA / PANDA III
- Conditions
- Acute Aortic Syndrome, Aortopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Anzhen Hospital, West China Hospital, The First Affiliated Hospital of Guangzhou Medical University, The Affiliated Hospital of Qingdao University Medical College
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin | Experimental | Drug: Rosuvastatin 10mg |
| Blank | No intervention | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (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.
Key exclusion criteria (6 listed)
- (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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin 10mgRosuvastatin 10mg is taken by oral or nasal feeding every day at ang time. | Drug | Statin |
Primary outcome
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.
1 secondary outcome
Mortality
Time frame: 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rosuvastatin 10mg in people with Acute Aortic Syndrome and Aortopathy, run by Nanjing Medical University at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Liu, MD (18801281613, DR.HONGLIU@FOXMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic adverse events (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.