NCT07250035 Jiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated With Cerebral Amyloid Angiopathy
| NCT ID | NCT07250035 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Cerebral Amyloid Angiopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 436 participants |
| Start Date | 2026-01-30 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 436 participants in total. It began in 2026-01-30 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cerebral hemorrhage, as a serious cerebrovascular disease, has the highest disability rate and mortality rate among all types of cerebrovascular diseases .It has brought a heavy burden to society. In China, the incidence of cerebral hemorrhage is much higher than that in Europe and America, and cerebral amyloid angiopathy (CAA) is one of the causes of primary cerebral hemorrhage However, there are relatively few related studies. Therefore, the research object of this subject focuses on patients with cerebral amyloid angiopathy, in view of their high recurrence rate of vascular events and the lack of treatment methods.It aims to deeply explore the detoxification and blood stasis removal treatment plan combining traditional Chinese and Western medicine to reduce vascular events for patients.
Eligibility Criteria
Inclusion Criteria: * ① Possible or very likely CAA-ICH; * Within 7 days of onset; ③ Primary supratentorial intracerebral hemorrhage (bleeding volume ≤40ml); * GCS≥8 points; * NIHSS score ≤25 points; ⑥50≤age≤90 years old; ⑦ Gender is not limited; ⑧ The subject or their legal representative gives informed consent and signs the informed consent form. Exclusion Criteria: * Those who are known to be allergic to the components of the traditional Chinese medicine compound used in the experiment; * It is known that after treatment with vascular malformations, aneurysms, coagulation disorders, anticoagulant or antiplatelet drugs, Intracranial conditions caused by clear etiologies such as thrombolytic therapy, post-infarction hemorrhage transformation, hematological diseases, moyamoya disease, etc; * Patients with traumatic intracranial hemorrhage; * Patients with active peptic ulcers or other clear tendencies of rebleeding; * Patients with severe liver or kidney dysfunction (Note: Severe liver dysfunction is defined as ALT or AST being greater than. ⑥ Those who have received or are planning to undergo surgical treatment; ⑦ Those who suffer from other life-threatening serious diseases and have an expected survival time of less than six months; ⑧ Other conditions that significantly limit the evaluation of neurological function, prevent the completion of cranial magnetic resonance imaging, or affect the follow-up of patient; ⑨ Pregnant women, those planning to become pregnant or lactating women; ⑩Those who are currently participating in other interventional clinical trials.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07250035 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 90 Years, studying Cerebral Amyloid Angiopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07250035 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 436 participants.
Is NCT07250035 currently recruiting?
Yes, NCT07250035 is actively recruiting participants. Contact the research team at shuxianlyu@163.com for enrollment information.
Where is the NCT07250035 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07250035 clinical trial?
NCT07250035 is sponsored by Beijing Tiantan Hospital. The trial plans to enroll 436 participants.