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Clinical Trial NCT07250035 (CHN-CAA) for Cerebral Amyloid Angiopathy is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Jiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated With Cerebral Amyloid Angiopathy (CHN-CAA) Phase 3 436

Not yet recruiting
Clinical Trial NCT07250035 (CHN-CAA) is designed to study Treatment for Cerebral Amyloid Angiopathy. This Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on 20 December 2025 until the study accrues 436 participants. Led by Beijing Tiantan Hospital, this study is expected to complete by 30 November 2028. The latest data from ClinicalTrials.gov was last updated on 11 December 2025.
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 rela...Show More
Detailed Description
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 rela...Show More
Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study of Jiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated With Cerebral Amyloid Angiopathy

Conditions
Cerebral Amyloid Angiopathy
Other Study IDs
  • CHN-CAA
  • 2024ZD0522204
NCT ID Number
NCT07250035
Start Date (Actual)
2025-12-20
Last Update Posted
2025-12-11
Completion Date (Estimated)
2028-11-30
Enrollment (Estimated)
436
Study Type
Interventional
PHASE
Phase 3
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Placebo ComparatorPlacebo Comparator
Placebo
A placebo similar to the Jiedu Huayu Oral Prescription
ExperimentalExperimental
Jiedu Huayu Oral Prescription
Jiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated with Cerebral Amyloid Angiopathy
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Vascular events
Incidence of vascular events, including hemorrhagic and ischemic vascular events.
180 days after onset
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Incidence of Vascular Events at 30 Days
Incidence of vascular events.
30 days after onset
Incidence of Vascular Events at 90 Days
Incidence of vascular events.
90 days after onset
Incidence of Vascular Events at 1 Year
Incidence of vascular events.
1 year after onset
Changes in Neurocognitive Function
Changes in neurocognitive function assessed by TICS-M, MMSE, and MOCA scales.
180 days after onset
Neurological Function Recovery at 30 Days
Neurological function recovery evaluated by mRS score.
30 days after onset
Neurological Function Recovery at 90 Days
Neurological function recovery evaluated by mRS score.
90 days after onset
Neurological Function Recovery at 180 Days
Neurological function recovery evaluated by mRS score.
180 days after onset
Neurological Function Recovery at 1 Year
Neurological function recovery evaluated by mRS score.
1 year after onset
Changes in Quality of Life at 30 Days
Changes in quality of life assessed by SF-36 and EQ-5D scales.
30 days after onset
Changes in Quality of Life at 90 Days
Changes in quality of life assessed by SF-36 and EQ-5D scales.
90 days after onset
Changes in Quality of Life at 180 Days
Changes in quality of life assessed by SF-36 and EQ-5D scales.
180 days after onset
Changes in Quality of Life at 1 Year
Changes in quality of life assessed by SF-36 and EQ-5D scales.
1 year after discharge
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
50 Years
Eligible Sexes
All

  • ① Possible or very likely CAA-ICH;

    • Within 7 days of onset; ③ Primary supratentorial intracerebral hemorrhage (bleeding volume ≤30ml);

      • 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.

  • 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.

Beijing Tiantan Hospital logoBeijing Tiantan Hospital
Study Central Contact
Contact: Dandan Wang Wang, +8615053772817, [email protected]
1 Study Locations in 1 Countries
Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China