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

NCT ID: NCT04699279

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Aortic Syndrome Aortopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Statin

Group Type EXPERIMENTAL

Rosuvastatin 10mg

Intervention Type DRUG

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

Blank

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rosuvastatin 10mg

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Qingdao University Medical College

UNKNOWN

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hong Liu

Principal Investigator of Cardiovascular surgery Dept.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

The first affiliated hospital of nanjing medical university

Nanjing, Jiangsu, China

Site Status RECRUITING

Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Beijing Anzhen Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hong Liu, MD

Role: CONTACT

Phone: 18801281613

Email: [email protected]

Yong-feng SHAO, MD

Role: CONTACT

Phone: 18801281613

Email: [email protected]

Facility Contacts

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Ying-yuan Zhang, MD

Role: primary

Ying-yuan Zhang, MD

Role: backup

Hong Liu, MD

Role: primary

Ji-nong Yang, MD

Role: primary

Ji-nong Yang, MD

Role: backup

Hong-hua Yue, MD

Role: primary

Hong-hua Yue, MD

Role: backup

Si-chong Qian, MD

Role: primary

Other Identifiers

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PANDA III

Identifier Type: -

Identifier Source: org_study_id