About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Jiedu Huayu Oral Prescription
DrugJiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated with Cerebral Amyloid Angiopathy
Placebo
DrugA placebo similar to the Jiedu Huayu Oral Prescription
Treatment groups
Trial outcomes
Primary outcomes
Vascular events
Incidence of vascular events, including hemorrhagic and ischemic vascular events.
Secondary outcomes
Incidence of Vascular Events at 30 Days
Incidence of vascular events.
Incidence of Vascular Events at 90 Days
Incidence of vascular events.
Incidence of Vascular Events at 1 Year
Incidence of vascular events.
Changes in Neurocognitive Function
Changes in neurocognitive function assessed by TICS-M, MMSE, and MOCA scales.
Other outcomes
Safety Indicators at 7 Days
Hematoma expansion rate in safety indicators (defined as a 33% increase in hematoma volume or an absolute increase of 6ml compared with the baseline CT hematoma volume).
Safety Indicators at 14 Days
Hematoma expansion rate in safety indicators (using the same evaluation standard as that at 7 days after onset).
Safety Indicators during medication
Incidence of newly developed severe liver and kidney function abnormalities in safety indicators.
Safety Indicators during entire study period
Incidence of non-vascular death, adverse events/serious adverse events reported by researchers.
Sponsors and contacts
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Beijing Tiantan Hospital
Lead sponsor
Dongzhimen Hospital, Beijing
Collaborator
The First Hospital of Jilin University
Collaborator
Huairou Hospital of Traditional Chinese Medicine
Collaborator
Weihai Wendeng District Central Hospital
Collaborator
Nanyang First People's Hospital of Henan province
Collaborator
Luohe Central Hospital
Collaborator
Baofeng County People's Hospital
Collaborator
Taoyuan County People's Hospital
Collaborator
Qingdao Huangdao District Central Hospital
Collaborator
Guantao County People's Hospital
Collaborator
Lushan County Hospital of Traditional Chinese Medicine
Collaborator
Yutian County Hospital of Traditional Chinese Medicine
Collaborator
Xianghe County Hospital of Traditional Chinese Medicine
Collaborator
Wuyuan County People's Hospital
Collaborator
Jiyuan Hospital of Traditional Chinese Medicine
Collaborator
Tonghua People's Hospital
Collaborator