NCT06112028

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Yanbin Li · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-11-01
• Completion: 2026-11-01
• First posted: 2023-11-01
• Last updated: 2023-11-01