Intravenous Thrombolysis in Acute Ischemic Stroke with Ac... | NCT06841965

NCT06841965

Protocol Section

Identification Module

Results Section

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No data is available for this block.

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intravenous thrombolysis (alteplase and other guideline-recommended thrombolytic agents))	Experimental	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).	Drug: Intravenous thrombolysis
Standard therapy	No Intervention	Standard therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravenous thrombolysis	Drug	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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Independent recovery assessed by ratio of modefied Rankin Scale (mRS) score of 0-2 (%) at 90 ± 7 days	mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome	90 ± 7 days

Secondary Outcomes

Measure	Description	Time Frame
Excellent recovery assessed by the ratio of modified Rankin Scale (mRS) score of 0-1 (%) at 90 ± 7 days	mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome	90 ± 7 days
recovery assessed by modefied Rankin Scale (mRS) score

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
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.)
Patients ≥ 18 years old
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：

Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hematoma, etc.)
Previous history of intracranial hemorrhage
Severe head trauma or stroke history within the last 3 months
Intracranial tumors, giant intracranial aneurysms
Intracranial or spinal surgery within the recent 3 months
Major surgical procedures within the last 2 weeks
Gastrointestinal or urinary tract bleeding within the last 3 weeks
Active visceral bleeding
Aortic arch dissection
Arterial puncture in a site within the last 1 week that is not easy to compress and stop bleeding
Elevated blood pressure: Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg
Acute bleeding tendency, including platelet count < 100 × 10⁹/L or other conditions
Received low-molecular-weight heparin treatment within 24 hours
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.
Blood sugar < 2.8 or > 22.22 mmol/L
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

Name	Role	Phone	Extension	Email
Min Lou, PhD, MD	Contact	8613958007213		lm99@zju.edu.cn
Wansi Zhong, MD	Contact	8618757155806		21718233@zju.edu.cn

ID	Term
D020521	Stroke
D000083242	Ischemic Stroke

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases