The Proteomic Study and Early Intervention Study of Carotid Unstable Plaque

NCT05622877 | Unknown Phase 1 DMC

• 1 other identifier: SZ2021ZZ3205
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Protein; Disease; Carotid Artery Plaque; Traditional Chinese Medicine

Keywords

Traditional Chinese Medicine; proteomic study; carotid atherosclerosis plaques

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in blood lipids

  6 moths

• Number of new cardiovascular events

  12 moths

Study Arms (3)

Placebo Group

PLACEBO COMPARATOR

Basic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and placebo granules (6g/ bag, one bag each time, twice a day after meals);

Drug: placebo; Other: Basic treatment

Qushi Formula Group

EXPERIMENTAL

Basic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and Qushi Formula granules (6g/ bag, one bag each time, twice a day after meals);

Drug: Qushi Formula; Other: Basic treatment

Zhu's Wenban Formula Group

EXPERIMENTAL

Basic treatment according to the 2014 Chinese Guidelines for Secondary Prevention of Ischemic Stroke/Transient Ischemic Attack and Zhu's Wenban Formula granules (6g/ bag, one bag each time, twice a day after meals);

Drug: Zhu's Wenban Formula; Other: Basic treatment

Interventions

Qushi Formula DRUG

Qushi Formula are decoction granules composed 8 traditional Chinese medicines, such as poria cocos, Macrocephalae Rhizoma, Polyporus, cassia twig, dried ginger and licorice, Etc.

Qushi Formula Group

Zhu's Wenban Formula DRUG

Zhu's Wenban granules are decoction granules composed of leech, panax notoginseng, Atractylodes Lancea and rhizome

Zhu's Wenban Formula Group

placebo DRUG

The placebo was composed of dextrin, powdered sugar, starch, and liquid caramel in the same color as the other two groups.

Placebo Group

Basic treatment OTHER

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.

Placebo Group; Qushi Formula Group; Zhu's Wenban Formula Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead

Study Sites (1)

Guangdong Province Hospital of Tradtional Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Disease; Carotid Stenosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 21, 2022
• Study Start: May 31, 2023
• Primary Completion: January 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

CN (1)