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Taking people in ChinaPhase 1

Tests two drugs given with clot removal for acute stroke

Tests whether two drugs given with clot removal are safe in adults with stroke.

Key facts

Who runs it
Capital Medical University
Where
Linyi, ChinaSee the site
Trial code
Registry title
Study on Hibernation-like Therapy Based on Mechanical Thrombectomy
Status
Recruiting
Phase
Phase 1
People taking part
32 people, planned
Started
9 Nov 2024
Planned end
Feb 2025
Type of study
Interventional, 5 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • chlorpromazine and promethazine
  • Placebo group
  • endovascular thrombectomy
  • rt-PA
Record updated
20 December 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18-80 with an acute stroke caused by a blocked large artery at the front of the brain, who can have clot-removal treatment.

Age
18 to 80 years
Sex
Women and men can join.
Disease stage
Acute ischemic stroke with a NIHSS score of 6-20, started within 24h of last known well, with a blocked large artery of the anterior circulation confirmed by CT angiography. ASPECT score 6-10. Initial infarct volume on CT perfusion below 70ml.
Earlier treatment
Before the stroke, the Modified Rankin Scale score must be 0-1. The person must be a candidate for reperfusion therapy (intravenous thrombolysis and/or endovascular thrombectomy). Taking part in another trial with an investigational drug or device is not allowed.
Biomarker or test result
CT perfusion must show a ratio of hypoperfused volume to infarcted volume above 1.8 and a mismatch volume above 15 ml.

Main reasons for not taking part

  • Bleeding in the brain or around the brain
  • Epilepsy, coma or mental disorders that may disturb the assessment
  • Allergy to phenothiazine or to iodine contrast medium
  • Severe heart, lung, liver or kidney disease
  • Pregnancy or breastfeeding

The registry criteria, word for word

Show all 3 criteriaShow less

Who can take part

  • Clinical Inclusion Criteria:; 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

Who cannot take part

  • Image exclusion criteria:; computed tomographic angiography(CTA)/magnetic resonance angiography(MRA)/digital substraction angiography(DSA) shows excessive vascular curvature, which may hinder delivery of interventional 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 bilateral or multi-regional infarction; 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
  • 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 <50mg/dL (2.78mmol) or >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 anticoagulants; If the investigator believes that the subject does not have coagulation dysfunction, it is not necessary to wait for the results of the coagulation test before deciding whether to enroll.); 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 Interventional Diagnosis and Treatment of Acute Ischemic Stroke 2022, expected survival less than 90 days is a contraindication for endovascular therapy); 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 (systolic blood pressure ≤100 mmHg after standard treatment), or pulmonary hypertension; Had unstable angina pectoris, myocardial infarction, or bypass or stent surgery within 6 months before randomization; New York Heart Association (NYHA) grade 3-4 history of chronic heart failure; Clinically significant valvular disease; Severe arrhythmias requiring treatment (except atrial fibrillation and paroxysmal supraventricular tachycardia), including QT interval ≥450ms for men and ≥470ms for women; accompanied by chronic obstructive pulmonary disease(COPD), tuberculosis, pneumonia, pneumothorax, atelectasis, pulmonary fibrosis, bronchopulmonary dysplasia, pleural effusion, acute respiratory distress syndrome, respiratory irregularity and other lung diseases; 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in China

  • Linyi People's HospitalLinyi, ChinaContact: Qi Wang, Dr.Taking people

About the trial

What the trial wants to find out

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:

Read full original descriptionShow less

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.

The 5 groups in the trial

  • chlorpromazine and promethazine of Very low dosageTreatment being tested

    patients will receive C+P(chlorpromazine and promethazine ,10 mg each)at the beginning of endovascular thrombectomy.

    Treatment: chlorpromazine and promethazine, endovascular thrombectomy, and rt-PA

  • chlorpromazine and promethazine of low-dosageTreatment being tested

    patients will receive C+P(chlorpromazine and promethazine ,20 mg each)at the beginning of endovascular thrombectomy.

    Treatment: chlorpromazine and promethazine, endovascular thrombectomy, and rt-PA

  • chlorpromazine and promethazine of moderate dosageTreatment being tested

    patients will receive C+P(chlorpromazine and promethazine ,50 mg each)at the beginning of endovascular thrombectomy.

    Treatment: chlorpromazine and promethazine, endovascular thrombectomy, and rt-PA

  • chlorpromazine and promethazine of high dosageTreatment being tested

    patients will receive C+P(chlorpromazine and promethazine ,100 mg each)at the beginning of endovascular thrombectomy.

    Treatment: chlorpromazine and promethazine, endovascular thrombectomy, and rt-PA

  • Placebo groupPlacebo, for comparison

    50 ml saline solution was delivered intravenously at the beginning of endovascular thrombectomyat a velocity of 4ml/h. The whole period of drug delivery lasts for approximately 12h.

    Treatment: Placebo group, endovascular thrombectomy, and rt-PA

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Safety and effiCacy of HIbernation-Like Therapy Combining recanaLization in Ischemic Stroke: a Phase 1, Dose-escalation Study
Plain-language title
Tests two drugs given with clot removal for acute strokeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06663631, who can take part
Record updated
20 December 2024