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

NCT ID: NCT06112028

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2026-11-30

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.

Detailed Description

Study participants aged 45-80 years who met the criteria for symptomatic or asymptomatic cerebral artery stenosis and successfully underwent cerebrovascular stenting were randomly divided into test group and control group. On the basis of routine oral treatment ,participants in experimental group were given Tongxinluo capsule. The control group received routine oral treatment. The routine follow-up sites were 1, 3, 6 and 12 months, and clinical data and blood were collected at the initial diagnosis and each follow-up site. SPSS software was used to analyze whether Tongxinluo capsule could reduce restenosis after intracranial and extracranial arterial stenting. During the follow-up, the adverse reactions such as bleeding and gastrointestinal tract were observed.

Conditions

Stent Restenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

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.

Group Type: EXPERIMENTAL

Tongxinluo capsule

Intervention Type: DRUG

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

Primary therapy

Intervention Type: OTHER

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

control group

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.

Group Type: SHAM_COMPARATOR

Primary therapy

Intervention Type: OTHER

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

Interventions

Tongxinluo capsule

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

Intervention Type: DRUG

Primary therapy

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yanbin Li

OTHER

Sponsor Role: lead

Responsible Party

Yanbin Li

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

07

Identifier Type: -

Identifier Source: org_study_id