Clinical Study of Tongxinluo Capsule in Preventing and Treating Restenosis After Intracranial and External Arterial Stenting

NCT06112028 | Not Yet Recruiting Phase 4

• 1 other identifier: 07
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Intrastent restenosis is a common complication after intracranial and extracranial arterial stenting and an important cause of recurrent ischemic stroke. Studies have shown that Tongxinluo capsule can protect the injured inner cells, reduce inflammation, inhibit the proliferation and migration of smooth muscle cells, inhibit the proliferation of plaque and nourish blood vessels, and resist arteriosclerosis. This study was a multicenter prospective randomized controlled clinical trial. Participants with intracranial and extracranial atherosclerotic stenosis who successfully underwent arterial stenting were included in the study, and were divided into Tongxinluo test group and control group. Clinical and related auxiliary examination data were collected at each follow-up point. To explore the effectiveness and potential mechanism of Tongxinluo capsule in preventing and treating restenosis after intracranial and external arterial stenting, and to provide reference for expanding clinical use of traditional Chinese medicine.

Conditions

Stent Restenosis

Keywords

traditional Chinese medicine; Stent Restenosis

Outcome Measures

Primary Outcomes (1)

• Changes of vascular stenosis rate after intracranial and extracranial arterial stenting

  According to NASCET experimental measurement standards, stenosis rate = (normal vascular lumen diameter - residual diameter at stenosis)/normal vascular lumen diameter \*100%. Comparison of CTA or DSA to evaluate the change of vascular stenosis rate after intracranial and extracranial arterial stenting; The incidence of cerebral ischemic events and intracranial hemorrhage events (responsible vessels and non-responsible vessels) were assessed by MR. Blood routine, liver and kidney function, blood lipids and hsCRP were recorded. The incidence and mortality of symptomatic intracranial hemorrhage were analyzed. Adverse events (e.g. abdominal pain, diarrhea, nausea, vomiting, bleeding, etc.)

  The 12th month

Study Arms (2)

Experimental group

EXPERIMENTAL

In addition to oral aspirin enteric coated tablets (0.1g qd), Clopidogrel bisulfate tablets (75mg qd), rosuvastatin calcium tablets (10mg qd) or atorvastatin calcium tablets (20mg qd), Tongxinluo capsule (Shijiazhuang Yilin Pharmaceutical Co., LTD.) was added to 0.78g TID for continuous treatment for 12 months.

Drug: Tongxinluo capsule; Other: Primary therapy

control group

SHAM COMPARATOR

Take aspirin enteric coated tablets (0.1g qd), Clopidogrel bisulfate tablets (75mg qd), Rosuvastatin calcium tablets (10mg qd) or atorvastatin calcium tablets (20mg qd) orally.

Other: Primary therapy

Interventions

Tongxinluo capsule DRUG

On the basis of conventional treatment, the study participants in the experimental group were given Tongxinluo capsule for 12 months.

Experimental group

Primary therapy OTHER

Routine oral aspirin enteric-coated tablets, clopidogrel bisulfate tablets and rosuvastatin calcium tablets (or atorvastatin calcium tablets)

Experimental group; control group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The diagnosis of symptomatic cerebral artery stenosis study participants met the above diagnostic criteria; Participants in the study with asymptomatic cerebral artery stenosis or asymptomatic cerebral artery stenosis met the indications for stent implantation in the Chinese Guidelines for Intravascular Interventional Treatment of Ischemic Cerebrovascular Diseases 2015, and successfully underwent cerebrovascular stenting (residual stenosis after vascular opening ≤30% after stent implantation).
• I am 45-80 years old and I and my family members agree to participate in this study.
• It can tolerate statin and platelet therapy without serious complications.

You may not qualify if:

• Patients with other intracranial lesions;
• Recent bleeding history or bleeding tendency;
• Patients with severe cardiac, liver and renal insufficiency, hypertension and diabetes were not well controlled;
• (4) Severe symptoms of stroke or neurological impairment and unstable symptoms after surgery;
• (5) Severely infected persons who cannot be controlled;
• ⑥ Patients who stop taking medicine for more than 2 months for various reasons;
• ⑦ Taking proprietary Chinese medicine or traditional Chinese medicine with similar efficacy.

Sponsors & Collaborators

• Yanbin Li: lead

MeSH Terms

Interventions

tongxinluo

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: November 1, 2023
• Study Start: October 1, 2023
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 1, 2023

Record last verified: 2023-10