To test the feasibility, efficacy and safety of combined intravenous (IV) and intraarterial (IA) recombinant tissue plasminogen activator (rt-PA) within 3 hours of stroke symptom onset.
- Tissue plasminogen activator (Activase®)Drug
Intervention Desc: Thrombolytic
Double-blind, randomized, placebo-controlled, multi-center trial involving 36 patients.
18 patients were randomized to receive intravenous (IV) rt-PA and 18 received IV placebo followed by immediate cerebral arteriography and local intra-arterial (IA) administration of rt-PA by means of a microcatheter.
|Type||Measure||Time Frame||Safety Issue|
|Primary||7 point improvement on the National Institutes of Health Stroke Scale Score (NIHSSS) at 0, 1 or 7 days.|
|Secondary||Barthel Index, modified Rankin Scale, and Glasgow outcome Scale measured at 3 months; mortality, arterial recanalization rates and their relations to total rt-PA dose and time to lysis, rates of life-threatening bleeding, intracerebral hemorrhage (ICH) or other bleeding complications to assess safety.|