Jiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated With Cerebral Amyloid Angiopathy

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50-90
SponsorBeijing Tiantan Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Jiedu Huayu Oral Prescription

    Drug

    Jiedu Huayu Oral Prescription in the Treatment of Intracranial Hemorrhage Associated with Cerebral Amyloid Angiopathy

  • Placebo

    Drug

    A placebo similar to the Jiedu Huayu Oral Prescription

Treatment groups

436 Participants
are divided into 2 treatment groups
Group A: Placebo ComparatorPlacebo comparator 1 intervention
Group B: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Vascular events

Incidence of vascular events, including hemorrhagic and ischemic vascular events.

Time frame
180 days after onset

Secondary outcomes

1

Incidence of Vascular Events at 30 Days

Incidence of vascular events.

Time frame
30 days after onset
2

Incidence of Vascular Events at 90 Days

Incidence of vascular events.

Time frame
90 days after onset
3

Incidence of Vascular Events at 1 Year

Incidence of vascular events.

Time frame
1 year after onset
4

Changes in Neurocognitive Function

Changes in neurocognitive function assessed by TICS-M, MMSE, and MOCA scales.

Time frame
180 days after onset

Other outcomes

1

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).

Time frame
7 days after onset
2

Safety Indicators at 14 Days

Hematoma expansion rate in safety indicators (using the same evaluation standard as that at 7 days after onset).

Time frame
14 days after onset
3

Safety Indicators during medication

Incidence of newly developed severe liver and kidney function abnormalities in safety indicators.

Time frame
During medication
4

Safety Indicators during entire study period

Incidence of non-vascular death, adverse events/serious adverse events reported by researchers.

Time frame
Entire study period

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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