Stroke, Acute Ischemic Stroke
Conditions
Brief summary
The primary hypothesis being tested in this trial is that ischemic stroke patients with prior ischemic stroke within 3 months will have improved clinical outcomes when given intravenous thrombolysis compared to standard care.
Interventions
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).
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 prior ischemic stroke within 3 months 3. Patients ≥ 18 years old 4. Informed consent has been obtained depending on local ethics requirements.
Exclusion criteria
(1) Plan to receive 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Independent recovery assessed by ratio of modefied Rankin Scale (mRS) score of 0-2 (%) at 90 ± 7 days | 90 ± 7 days | mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| recovery assessed by modefied Rankin Scale (mRS) score | 90 ± 7 days | mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome |
| 3-month mortality | 90 ± 7 days | Hospitalization records or follow-up results |
| Presence of parenchymal hemorrhage (PH) evaluated by CT or MRI | at day 1 | the presence of PH is defined according the standard from ECASS-2 study |
| Excellent recovery assessed by the ratio of modified Rankin Scale (mRS) score of 0-1 (%) at 90 ± 7 days | 90 ± 7 days | mRS: minimum value = 0, maximum value = 6, and lower scores mean a better outcome |
| Presence of hemorrhagic transformation evaluated by CT or MRI | at day 1 | Presence of hemorrhagic transformation is defined according the standard from ECASS-2 study |
| the change on the NIHSS score from baseline to 24 hours | 24 hours | NIHSS: minimum value = 0, maximum value = 42, and higher scores mean severer symptoms |
| Presence of symptomatic intracerebral hemorrhage (sICH) evaluated by CT or MRI | at day 1 | the presence of sICH is defined according the standard from ECASS-2 study |
Contacts
Primary ContactMin Lou
Backup ContactWansi Zhong, MD
Outcome results
None listed