Stent RestenosisPhase 4NCT06112028
Clinical Study of Tongxinluo Capsule in Preventing and Treating Restenosis After Intracranial and External Arterial Stenting
A Phase 4 study testing Tongxinluo capsule and Primary therapy in people with Stent Restenosis, run by Yanbin Li.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Stent Restenosis
- What is being tested?
- Tongxinluo capsule and Primary therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- Severe symptoms of stroke or neurological impairment and unstable symptoms after surgery;
- 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.
About this study
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.
Read the 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
- Being tested
- Tongxinluo capsule, Primary therapy
- Keywords
- traditional Chinese medicine, Stent Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongxinluo capsuleDrug
On the basis of conventional treatment, the study participants in the experimental group were given Tongxinluo capsule for 12 months.
Primary therapyOther
Routine oral aspirin enteric-coated tablets, clopidogrel bisulfate tablets and rosuvastatin calcium tablets (or atorvastatin calcium tablets)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Primary therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: The 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study startOct 2023 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stent RestenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanbin Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanbin Li, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112028
- Sponsor's protocol ID
- 07
- Status last verified
- Oct 2023
- First submitted
- 8 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Tongxinluo Capsule in Preventing and Treating Restenosis After Intracranial and External Arterial Stenting
- ClinicalTrials.gov ID
- NCT06112028
- Acronym / sponsor ID
- 07
- Conditions
- Stent Restenosis
- Keywords
- traditional Chinese medicine, Stent Restenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yanbin LiUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Tongxinluo capsule, Other: Primary therapyIn 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. |
| control group | Sham comparator | Other: Primary therapyTake aspirin enteric coated tablets (0.1g qd), Clopidogrel bisulfate tablets (75mg qd), Rosuvastatin calcium tablets (10mg qd) or atorvastatin calcium tablets (20mg qd) orally. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- Patients with other intracranial lesions;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tongxinluo capsuleOn the basis of conventional treatment, the study participants in the experimental group were given Tongxinluo capsule for 12 months. | Drug | Experimental group |
| Primary therapyRoutine oral aspirin enteric-coated tablets, clopidogrel bisulfate tablets and rosuvastatin calcium tablets (or atorvastatin calcium tablets) | Other | Experimental group, control group |
Primary outcome
Changes of vascular stenosis rate after intracranial and extracranial arterial stenting
Time frame: The 12th month
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.)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tongxinluo capsule and Primary therapy in people with Stent Restenosis, run by Yanbin Li.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of vascular stenosis rate after intracranial and extracranial arterial stenting (time frame: The 12th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.