24 Hours Treatment with Alteplase in Patients with Ischemic Stroke

Korábbi kezelés

• Participation in other interventional clinical trials within the previous three months

Más betegség

• Any condition that, in the judgment of the investigator, could impose hazards if study therapy is initiated or affect patient participation in the study

Laborértékek

• Contraindications for alteplase:
  • Allergy to alteplase
  • Rapidly improving symptoms at the discretion of the investigator
  • The presence of epileptic seizures, hemiplegia after seizures (Todd's palsy), or other neurological/mental illness that prevents cooperation or willingness to participate
  • Persistent blood pressure elevation (systolic ≥180 mmHg or diastolic ≥100 mmHg) despite treatment
  • Blood glucose levels outside the acceptable range (<2.8 or >22.2 mmol/L, point-of-care glucose testing accepted)
  • High risk of bleeding due to active internal bleeding, major surgery, trauma, gastrointestinal, or urinary tract hemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days
  • Known impairments in coagulation due to comorbid disease or anticoagulant use, including an INR >1.7 or prothrombin time >15 seconds for those on warfarin, recent use of direct thrombin inhibitors or direct factor Xa inhibitors without reversal capability, or full-dose heparin/heparinoid within the last 24 hours with an aPTT above normal limits
  • Known defect in platelet function or a platelet count below 100,000/mm³
  • History of ischemic stroke, myocardial infarction, intracranial hemorrhage, severe traumatic brain injury, or intraspinal operation within the previous 3 months, or known intracranial neoplasm, arteriovenous malformation, or giant aneurysm
  • Acute or past intracerebral hemorrhage identified by CT or MRI

Egyéb

• Intended to proceed to endovascular treatment
• Large (more than one-third of the territory of middle cerebral artery) region of clear hypodensity on CT scan
• Pregnancy, nursing, or unwillingness to use effective contraceptive measures during the trial period
• Likelihood of non-adherence to the trial protocol or follow-up
• Life expectancy of less than three months

• Patients presenting with clinical signs of acute ischemic stroke between 4.5 and 24 hours from stroke onset, or awakening and unwitnessed stroke (if the midpoint of the last known well time is within 4.5 to 24 hours)
• Patients aged > 18 years
• NIHSS range from 4 to 26
• Imaging inclusion criteria: ischemic core volume ≤ 70 mL, penumbra ≥ 10 mL and mismatch ≥ 20% (as evaluated by CT-perfusion)
• Pre-stroke mRS score < 2
• Informed consent has been obtained from the patient, a family member, or a legally responsible person, depending on local ethics requirements