Is ateplase safe and effective for ischemic stroke patients when administered 3 to 4.5 hours after the onset of symptoms?
Patients with ischemic stroke who received IV ateplase 3 to 4.5 hours after symptom onset had significant improvement in clinical outcomes. However, ateplase was associated with more frequent symptomatic intracranial hemorrhage.
- Double blinded, multicenter, randomized controlled trial
- multiple centers across Europe
N= 821 (enrolled between July 29, 2003 and November 13, 2007 from 130 sites in 19 European countries)
- Treatment group N= 418
- Placebo group N= 403
- No significant difference between ateplase and placebo group except for stroke severity and history of stroke.
- Ateplase group had an NIHSS score average of 10.7 while the placebo group had a score of 11.6
- 14.1% of the placebo group had a history of stroke while only 7.7% of the ateplase group had a history of stroke.
- Age: 18-80
- Acute ischemic stroke
- Symptom onset 3-4.5 hours prior to study intervention
- Continuous symptoms for at least 30 minutes without improvement prior to intervention
- Time of symptom onset unknown
- Intracranial hemorrhage
- Improvement in symptoms/minimal symptoms prior to administration of study drug
- Severe stroke (NIHSS >25 or by imaging)
- Previous stroke, head trauma, surgery, or severe trauma within 3 months
- History of stroke + diabetes
- Seizure at symptoms onset
- Administration of Heparin within 48 hours of symptom onset and elevated PTT
- Platelets <100,000
- SBP>185 or DBP>110
- Glucose <50 or >400
- Symptoms suggesting SAH
- On anticoagulation
- Disorders with increased risk of bleeding