Intravenous Thrombolysis in Acute Ischemic Stroke with Active Cancer

Study Purpose

The primary hypothesis being tested in this trial is that ischemic stroke patients with active cancer will have improved clinical outcomes when given intravenous thrombolysis compared to standard care.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients with clinical signs of acute ischemic stroke within 24 hours of onset or awakening with stroke (if within 24 hours from the midpoint of sleep). Patients with AIS within 4.5-24 hours of onset must meet the IVT inclusion criteria specified in the guideline. 2. Patients with active cancer (Active cancer was defined as cancer diagnosed within the previous 6 months; recurrent, regionally advanced or metastatic cancer, or cancer for which treatment had been administered within 6 months, or haematological cancer without complete remission.) 3. Patients ≥ 18 years old. 4. Informed consent has been obtained depending on local ethics requirements.

Exclusion Criteria:

(1) Intended to proceed to endovascular treatment; (2) Pre-stroke mRS score > 2 (3) Contraindications for IVT： 1.

Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hematoma, etc.) 2. Previous history of intracranial hemorrhage. 3. Severe head trauma or stroke history within the last 3 months. 4. Intracranial tumors, giant intracranial aneurysms. 5. Intracranial or spinal surgery within the recent 3 months. 6. Major surgical procedures within the last 2 weeks. 7. Gastrointestinal or urinary tract bleeding within the last 3 weeks. 8. Active visceral bleeding. 9. Aortic arch dissection. 10. Arterial puncture in a site within the last 1 week that is not easy to compress and stop bleeding. 11. Elevated blood pressure: Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg. 12. Acute bleeding tendency, including platelet count < 100 × 10⁹/L or other conditions. 13. Received low-molecular-weight heparin treatment within 24 hours. 14. Oral anticoagulants (warfarin) with INR > 1.7 or PT > 15 s; Receiving heparin treatment with aPTT above the upper limit of the normal range within the last 24 hours of onset, Receiving thrombin inhibitors and factor Xa inhibitors within the last 48 hours of onset. 15. Blood sugar < 2.8 or > 22.22 mmol/L. 16. Head CT or MRI indicates large-area infarction (infarction area ≥ 1/3 of the middle cerebral artery supply area) (4) The judgment is left to the discretion of the investigator

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06841965
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Second Affiliated Hospital, School of Medicine, Zhejiang University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Min Lou, PhD, MD
Principal Investigator Affiliation	Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Stroke, Acute Ischemic Stroke

Arms & Interventions

Arms

Experimental: Intravenous thrombolysis (alteplase and other guideline-recommended thrombolytic agents))

Patients will receive standard dose intravenous alteplase (0.9 mg/kg, the first 10% administered as an initial bolus and the remainder over a 1-hour period, with a maximum dose of 90 mg)，intravenous Tenecteplase(0.25mg/kg，administered as a single intravenous bolus injection over 5 - 10 seconds，with a maximum dose of 25 mg), intravenous reteplase (a bolus of 18 mg followed by a second bolus of 18 mg after 30 minutes) and intravenous prourokinase (rhPro-UK) (15 mg bolus followed by a 20 mg infusion over 30 minutes).

No Intervention: Standard therapy

Standard therapy

Interventions

Drug: - Intravenous thrombolysis

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Min Lou, PhD, MD

[email protected]

8613958007213

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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