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

NCT06112028 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-11-01

No results posted yet for this study

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

Interventions

DRUG

Tongxinluo capsule

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

OTHER

Primary therapy

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

Sponsors & Collaborators

  • Yanbin Li

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2025-11-30
Completion
2026-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06112028 on ClinicalTrials.gov