Actively Recruiting
Study on Hibernation-like Therapy Based on Mechanical Thrombectomy
Led by Capital Medical University · Updated on 2024-12-20
32
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
C
Capital Medical University
Lead Sponsor
L
Linyi People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn whether chlorpromazine and promethazine（C+P）is safe in Acute Ischemic Stroke（AIS) patients and determine the maximum dosage. It will also evaluate the preliminary efficacy of C+P in AIS. The main questions it aims to answer are: What is the optimal dosage of C+P that is safe without causing adverse effects in AIS patients? What is the optimal dosage of C+P that potentially works to treat AIS? Researchers will compare C+P with placebo (saline solution without C+P) to see if C+P is safe and effective in treating Acute Ischemic Stroke. Participants will: Receive C+P or placebo at the same time as endovascular thrombectomy begins. Patients will be observed for 72 hours to see if there were any adverse effects related to C+P. Infarct volumes will be evaluated using Computed Tomography. Functional outcomes will be assessed at 90 days.
CONDITIONS
Official Title
Study on Hibernation-like Therapy Based on Mechanical Thrombectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years, inclusive
- Ischemic stroke with NIH Stroke Scale score from 6 to 20
- Time from last known well to randomization within 24 hours
- Pre-stroke Modified Rankin Scale score of 0 to 1
- Eligible for reperfusion therapy including intravenous thrombolysis and endovascular thrombectomy
- Signed informed consent by patient or legal representative
- CT angiography confirmed large vessel occlusion in anterior circulation
- Alberta Stroke Program Early CT Score (ASPECT) of 6 to 10
- Initial infarct volume less than 70 ml on CT perfusion with specific mismatch criteria according to DEFUSE-3 trial
You will not qualify if you...
- Signs of intracranial hemorrhage or subarachnoid hemorrhage
- History of epilepsy
- Presence of coma or mental disorders interfering with neurological assessment
- History of allergy or contraindication to phenothiazine drugs
- Allergy to iodine contrast medium or anaphylactic shock
- Baseline blood glucose below 50 mg/dL or above 400 mg/dL
- Baseline platelet count below 50 x 10^9/L
- Recent significant bleeding or active bleeding disorders
- Stroke accompanied by fever or active infection requiring treatment
- Expected survival less than 90 days
- Severe cardiovascular disease including uncontrolled hypertension, hypotension, unstable angina, recent myocardial infarction, severe heart failure, valvular disease, or serious arrhythmias
- Chronic lung diseases such as COPD, tuberculosis, pneumonia, pneumothorax, pulmonary fibrosis, or acute respiratory distress syndrome
- Severe liver or kidney failure including cirrhosis, encephalopathy, renal failure, or hepatorenal syndrome
- Pregnancy or breastfeeding
- Participation in other clinical trials or use of investigational drugs or devices
- Conditions preventing study completion or deemed unsuitable by investigator
- Imaging findings: excessive vascular curvature, suspected cerebrovascular inflammation or aortic dissection, multi-vascular occlusion, moyamoya disease or syndrome, significant midline brain shift, intracranial tumors except cerebellar meningioma, or intracranial hemorrhage
AI-Screening
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Trial Site Locations
Total: 1 location
1
Linyi People's Hospital
Linyi, Shandong, China, 276000
Actively Recruiting
Research Team
X
Xunming Ji, Doctor
CONTACT
H
Hao Wang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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