Endovascular Stroke Treatment And Reteplase Protocol
Status:
Not yet recruiting
Trial end date:
2024-07-01
Target enrollment:
Participant gender:
Summary
The proposed study is a multicenter, prospective, randomized, open-label, blinded-endpoint
trial involving patients with ischemic stroke who are candidates for receiving intravenous
(IV) thrombolysis within 4.5 hours after stroke onset. The study aims to test the hypothesis
that anterior circulation ischemic stroke patients, selected with "dual target" vessel
occlusion within 4.5 hours of onset, will have improved reperfusion and early neurological
improvement when treated with intra-arterial clot retrieval after IV reteplase, compared to
IV alteplase. Patients will be randomized into one of three treatment arms: local
institutional IV thrombolysis, IV reteplase (9 U bolus), or IV reteplase (9 U bolus + 9 U
bolus). The study will assess the primary angiographic endpoint of partial or complete
recanalization following administration of thrombolytics, as well as the time of
recanalization and the time from symptom onset to recanalization. Additional outcome measures
include early neurological improvement, assessed by a ≥4-point improvement in National
Institutes of Health Stroke Scale (NIHSS) score in the first 24 hours compared to baseline.
The trial will be conducted in three groups based on the site of baseline arterial occlusion:
internal carotid artery (ICA), proximal middle cerebral artery (MCA - M1), or distal middle
cerebral artery (MCA - M2). The study aims to evaluate third-generation thrombolytic -
RETAVASE® (reteplase) and compare it to IV alteplase, in acute ischemic stroke patients.