Clinical trial NCT06841978: Intravenous Thrombosis and Patients with Prior Ischemic Stroke Within 3 Months
Official title: Intravenous Thrombosis in Acute Ischemic Stroke Patients with Prior Ischemic Stroke Within 3 Months
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Stroke
Acute Ischemic Stroke
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 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

Primary outcomes:
measure: Independent recovery assessed by ratio of modefied Rankin Scale (mRS) score of 0-2 (%) at 90 ± 7 days
timeFrame: 90 ± 7 days
Secondary outcomes:
measure: Excellent recovery assessed by the ratio of modified Rankin Scale (mRS) score of 0-1 (%) at 90 ± 7 days
timeFrame: 90 ± 7 days
measure: recovery assessed by modefied Rankin Scale (mRS) score
timeFrame: 90 ± 7 days
measure: 3-month mortality
timeFrame: 90 ± 7 days
measure: Presence of parenchymal hemorrhage (PH) evaluated by CT or MRI
timeFrame: at day 1
measure: Presence of symptomatic intracerebral hemorrhage (sICH) evaluated by CT or MRI
timeFrame: at day 1
measure: Presence of hemorrhagic transformation evaluated by CT or MRI
timeFrame: at day 1
measure: the change on the NIHSS score from baseline to 24 hours
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Min Lou, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: