The Proteomic Study and Early Intervention Study of Carotid Unstable Plaque

Carotid Artery Plaque Clinical Trial

Official title:

The Proteomic Study and Early Intervention Study of Carotid Unstable Plaque

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05622877
• Other study ID #: SZ2021ZZ3205
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 31, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study on the prediction model of carotid unstable plaque protein and its early intervention. Protein antibody chip was used to detect the remaining biological samples, and patients with carotid artery unstable plaque with stroke risk were selected for interventional clinical trials. The selected patients were randomly divided into 3 groups, which were treated with Zhu's Wenban Formula (TCM compound granules), Qushi Formula (TCM compound granules) and placebo for 6 months, respectively. The size and number of carotid artery unstable plaques before and after 6 months were observed, and the occurrence of adverse reactions during the intervention period was observed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Wet syndrome scale assessment is consistent with wet syndrome diagnosis;
• Carotid color ultrasound indicated carotid artery unstable plaque.
• Protein chip analysis determined that the patients were at high risk of stroke
• Signing informed Consent

Exclusion Criteria:

• Carotid artery stenosis rate =50%;
• A definite or suspected diagnosis of vasculitis;
• Accompanied by infection, tumor, heart, liver and renal insufficiency (liver and
• kidney function more than twice the upper limit of normal value, cardiac function grade greater than or equal to 2);
• Patients with acute stroke or complicated with acute myocardial infarction and unstable angina pectoris;
• Pregnant or lactating women;
• A prior known allergy to the test drug or the test drug ingredient.

Related Conditions & MeSH terms

• Carotid Artery Plaque
• Carotid Stenosis
• Protein; Disease
• Traditional Chinese Medicine

Intervention

Drug:
• Qushi Formula
Qushi Formula are decoction granules composed 8 traditional Chinese medicines, such as poria cocos, Macrocephalae Rhizoma, Polyporus, cassia twig, dried ginger and licorice, Etc.
• Zhu's Wenban Formula
Zhu's Wenban granules are decoction granules composed of leech, panax notoginseng, Atractylodes Lancea and rhizome
• placebo
The placebo was composed of dextrin, powdered sugar, starch, and liquid caramel in the same color as the other two groups.

Other:
• Basic treatment
Basic diseases except hyperlipidemia were treated in accordance with the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack. Basic treatment includes conventional treatment such as comprehensive prevention and treatment (actively controlling basic diseases such as hypertension and diabetes and suggesting a good lifestyle), drug therapy (anti-inflammatory, lipid-regulating, anti-platelet aggregation, calcium channel blockers) and so on according to individual conditions of patients.

Locations

Country	Name	City	State
China	Guangdong Province Hospital of Tradtional Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in carotid artery unstable plaque	Changes in carotid IMT and the total volume and number of unstable plaques before and after 6 months of treatment	6 moths
Secondary	Changes in blood lipids	The changes of triglyceride, total cholesterol, low density lipoprotein and high density lipoprotein before and after 6 months of treatment;	6 moths
Secondary	Number of new cardiovascular events	Number of cardiovascular and cerebrovascular events during 6 months of treatment and 6 months of follow-up	12 moths