EBQ:ECASS III: Difference between revisions

Latest revision as of 14:14, 22 March 2016

Under Review Journal Club Article

Hacke W, et al. "Thrombolysis with Alteplase 3 to 4.5 Hours after Acute Ischemic Stroke". The New England Journal of Medicine. 2008. 359(13):1317-1329.
PubMed Full text PDF

Clinical Question

Is ateplase safe and effective for ischemic stroke patients when administered 3 to 4.5 hours after the onset of symptoms?

Conclusion

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.

Major Points

Study Design

Double blinded, multicenter, randomized controlled trial
- multiple centers across Europe

Population

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

Patient Demographics

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.

Inclusion Criteria

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

Exclusion Criteria

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

Interventions

Outcomes

Primary Outcome

Secondary Outcomes

Subgroup analysis

Criticisms & Further Discussion

Funding

Sources

Authors:

@@ Line 13: / Line 13: @@
 | fulltexturl=http://www.nejm.org/doi/full/10.1056/NEJMoa0804656
 | pdfurl=http://www.nejm.org/doi/pdf/10.1056/NEJMoa0804656
+| status=Under Review
 }}
 ==Clinical Question==
+'''Is ateplase safe and effective for ischemic stroke patients when administered 3 to 4.5 hours after the onset of symptoms?'''
 ==Conclusion==
+'''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.'''
 ==Major Points==
-==Guidelines==
+==Study Design==
+*Double blinded, multicenter, randomized controlled trial
+**multiple centers across Europe
-==Design==
+==Population==
+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
+===Patient Demographics===
+*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.
-==Population==
 ===Inclusion Criteria===
+*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
 ===Exclusion Criteria===
+*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
-===Baseline Characteristics===
+==Interventions==
-==Interventions==
+==Outcomes==
-==Outcomes==
+===Primary Outcome===
-===Primary Outcomes===
+===Secondary Outcomes===
-===Secondary Outcomes===
+===Subgroup analysis===
-==Subgroup Analysis==
+==Criticisms & Further Discussion==
-==Criticisms==
 ==Funding==
-==CME==
 ==Sources==
 <references/>
+[[Category:EBQ]]
+[[Category:Neurology]]