Status:
NOT_YET_RECRUITING
Clinical Study of Tongxinluo Capsule in Preventing and Treating Restenosis After Intracranial and External Arterial Stenting
Lead Sponsor:
Yanbin Li
Conditions:
Stent Restenosis
Eligibility:
All Genders
45-80 years
Phase:
PHASE4
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...
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 gr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06112028
Start Date
October 1 2023
End Date
November 1 2026
Last Update
November 1 2023
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