Ischemic Stroke
Conditions
Keywords
Cerebral Infarction, Ischemic Stroke, Thrombolysis
Brief summary
This is a double-blind parallel arm randomized trial aimed to assess efficacy and safety of intravenous Tenecteplase compared to intravenous Alteplase in eligible patients who present with symptoms of acute ischemic stroke within 3 to 4.5 hours from onset.
Detailed description
Patients presenting with symptoms of acute ischemic stroke (AIS) who present within 3 to 4.5 hours of symptom onset and who meet the inclusion criteria for intravenous (IV) thrombolysis will receive, in a randomized, double-blind fashion, either IV Alteplase at 0.9 mg/kg per standard protocol or IV Tenecteplase at 0.25 mg/kg with saline infusion over one hour. Patients must also have no exclusion criteria for IV thrombolysis within the 3 to 4.5 hour window. The only required imaging is non-contrasted CT of the head. Patients will be monitored according to standard post-thrombolytic care. A CT of the head will be performed at 24 hours based on standard protocol or if there is any neurological change. Neurological function at 24 hours using NIHSS and at 3 months based on modified mRS and the NIHSS.
Interventions
DRUGTenecteplase
Tenecteplase 0.25 mg/kg IV - Maximum 25 mg
DRUGAlteplase
Alteplase 0.9 mg/kg IV - Maximum: 90 mg
Sponsors
Reza Behrouz, DO
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 80 years 2. Acute neurologic deficit with an NIHSS ≥ 4 3. Non-enhanced computed tomography (NECT) of the head showing no hemorrhage 4. Acute ischemic stroke symptoms with onset, or time last known well, clearly defined between 3 and 4.5 hours 5. Treatment can be initiated within 3 to 4.5 hours from symptom onset
Exclusion criteria
1. Evidence of intracranial hemorrhage on NECT 2. Clinical suspicion of subarachnoid hemorrhage even with normal NECT 3. NECT shows hypo-density greater than 1/3 cerebral hemisphere) 4. History of intracranial hemorrhage/stroke 5. Uncontrolled HTN: At time treatment begins SBP remains \>185 mmHg or DBP remains \>110 mmHg despite repeated measurements 6. Known arteriovenous malformation, neoplasm, or aneurysm 7. Witnessed seizure at stroke onset 8. Acute bleeding tendencies 9. Platelet count \<100,000/mm3 10. Heparin received in prior 48 hours with elevated aPTT 11. Current use of an anticoagulant (Coumadin/Warfarin) irrespective of INR 12. Prior use (within 48 hours) of direct thrombin inhibitors (dabigatran) or direct factor Xa inhibitors (rivaroxaban, apixaban) 13. Within prior 3 months: intracranial or spinal surgery, head trauma, or previous stroke 14. Arterial puncture at non-compressible site within last 7 days 15. Woman of child bearing age who has a positive pregnancy test 16. NIH stroke scale \>25 (severe deficit) or \<4 and no dysphasia (mild deficit) or rapidly improving 17. Symptoms spontaneously clearing 18. 14 days post-operative or post major trauma 19. Recent gastrointestinal or urinary tract hemorrhage within the past 21 days 20. Recent acute MI within the past 3 months 21. Serum glucose \<50 mg/dl or \>400 mg/dL 22. Age \>80 or less than 18 23. History of ischemic stroke AND diabetes mellitus 24. Unable to obtain consent from patient or power of attorney 25. Baseline mRS \> 2 26. Consent not obtained by 20 minutes prior to closure of the therapeutic window. 27. The subject has been treated with a thrombolytic agent within the past 72 hours 28. The subject is a pregnant woman (positive serum βHCG pregnancy test, positive urine pregnancy test or clinically evident pregnancy) 29. The subject is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurological outcome | 90 days | Measured by modified Rankin Scale score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic intracranial hemorrhage | 24 hours | Twenty-four hour brain CT scan showing intracranial hemorrhage in conjuction with neurological deterioration of 4 points or more on the NIHSS |
Countries
United States
Outcome results
None listed