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New treatment option for Acute Ischemic Stroke
Official title Study on Hibernation-like Therapy Based on Mechanical Thrombectomy
ClinicalTrials.gov ID: NCT06663631
What this study is testing
What is chlorpromazine and promethazine?
chlorpromazine and promethazine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute ischemic stroke.
Also referred to as C+P, lytic cocktail.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Clinical
- Age between 18-80 years(including the critical value)
- Ischemic stroke with a National Institutes of Health Stroke Scale (NIHSS) score ranging from 6-20
- Time from last known to be well to randomization within 24h
- Pre-stroke Modified Rankin Scale scoring 0-1.
You likely can't join if
- Clinical Exclusion Criteria:
- Clinical findings suggest intracranial parenchymal hemorrhage or subarachnoid hemorrhage.
- Accompanied by epilepsy.
- Accompanied by coma or mental disorders, may interfere with neurological function assessment.
- History of premorbid phenothiazine allergy or contraindication.
- History of allergy to iodine contrast medium or anaphylactic shock
See the full eligibility criteria
- Clinical
- Age between 18-80 years(including the critical value)
- Ischemic stroke with a National Institutes of Health Stroke Scale (NIHSS) score ranging from 6-20
- Time from last known to be well to randomization within 24h
- Pre-stroke Modified Rankin Scale scoring 0-1.
- With indications of reperfusion therapy (including intravenous thrombolysis and endovascular thrombectomy).
- Informed consent signed by patients or their legal relatives.
- CT angiography (CTA) confirmed large vessel occlusion of anterior circulation
- Alberta Stroke Program Early Computed Tomography Score (ASPECT) score of 6-10.
- initial infarct volume on CT perfusion (CTP) lesser than 70ml; a ratio of hypoperfused volume to infarcted volume greater than 1.8; absolute mismatch volume greater than 15 ml according to DEFUSE-3 trial.
- Clinical Exclusion Criteria:
- Clinical findings suggest intracranial parenchymal hemorrhage or subarachnoid hemorrhage.
- Accompanied by epilepsy.
- Accompanied by coma or mental disorders, may interfere with neurological function assessment.
- History of premorbid phenothiazine allergy or contraindication.
- History of allergy to iodine contrast medium or anaphylactic shock
- Baseline blood glucose \ 400mg/dL (22.20mmol) \ Acceptable fingertip blood glucose results
- Baseline platelet \<50×109 /L
- Recent (i.e. within 30 days prior to randomization) history of gastrointestinal or other clinically significant bleeding; Active bleeding, abnormal clotting factors, or bleeding tendency (INR≥3 or PT≥3×ULN on...
- The stroke is accompanied by fever, or there is an active infection requiring systemic treatment (such as active tuberculosis, etc.)
- Expected survival less than 90 days (According to the Chinese Guidelines for Early Endovascular treatment Diagnosis and Treatment of Acute Ischemic Stroke 2022, expected survival less than 90 days is a contraindication...
- A history of severe cardiovascular disease, including but not limited to: uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg after standard treatment), hypotension...
- accompanied by chronic obstructive pulmonary disease（COPD）, tuberculosis, pneumonia, pneumothorax, atelectasis, pulmonary fibrosis, bronchopulmonary dysplasia, pleural effusion, acute respiratory distress syndrome...
- Severe hepatic and renal insufficiency, including but not limited to: cirrhosis, hepatic encephalopathy, ascites, renal failure or uremia (Ccr\<25ml/min), hepatorenal syndrome, etc
- Pregnancy or lactating women
- Participation in other clinical trials and have used an investigational drug or medical device
- Patients that may not be able to complete the study for other reasons or who the investigator believes should not be included
- Image exclusion criteria:
- computed tomographic angiography（CTA）/magnetic resonance angiography（MRA）/digital substraction angiography（DSA） shows excessive vascular curvature, which may hinder delivery of treatment devices
- Cerebrovascular inflammation is suspected based on medical history and CTA/MRA/DSA
- Aortic dissection is suspected based on medical history and CTA/MRA/DSA
- CTA/MRA/DSA confirmed multi-vascular regional occlusion (such as bilateral anterior circulation or anterior/posterior circulation, extracranial carotid artery with intracranial tandem lesions), or clinical evidence of...
- CTA/MRA/DSA confirms moyamoya disease or moyamoya syndrome
- CT/MRI confirmed a significant midline shift effect
- CT/MRI confirms the presence of intracranial tumors (except cerebellar meningioma) CT/MRI confirmed intracranial hemorrhage
The study team makes the final eligibility decision.
Where it's taking place
- Linyi, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Linyi, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.