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Not yet recruiting NCT06841978

Intravenous Thrombosis and Patients with Prior Ischemic Stroke Within 3 Months

Phase III Interventional Stroke Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intravenous Thrombolysis.
Who it may be relevant to
Registry conditions: Stroke, Acute Ischemic Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Intravenous Thrombosis in Acute Ischemic Stroke Patients with Prior Ischemic Stroke Within 3 Months

Overview

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

  • Drug Intravenous Thrombolysis
    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 infusio

Primary outcome measures

  • Independent recovery assessed by ratio of modefied Rankin Scale (mRS) score of 0-2 (%) at 90 ± 7 days [Time frame: 90 ± 7 days]
Secondary outcome measures (7)
  • Excellent recovery assessed by the ratio of modified Rankin Scale (mRS) score of 0-1 (%) at 90 ± 7 days [Time frame: 90 ± 7 days]
  • recovery assessed by modefied Rankin Scale (mRS) score [Time frame: 90 ± 7 days]
  • 3-month mortality [Time frame: 90 ± 7 days]
  • Presence of parenchymal hemorrhage (PH) evaluated by CT or MRI [Time frame: at day 1]
  • Presence of symptomatic intracerebral hemorrhage (sICH) evaluated by CT or MRI [Time frame: at day 1]
  • Presence of hemorrhagic transformation evaluated by CT or MRI [Time frame: at day 1]
  • the change on the NIHSS score from baseline to 24 hours [Time frame: 24 hours]

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 prior ischemic stroke within 3 months
  • Patients ≥ 18 years old
  • 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：

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06841978 · TIPS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗