NCT05900674

Endovascular Stroke Treatment And Reteplase Protocol

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Zeenat Qureshi Stroke Institute · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Reteplase Injection	To test the single dose of reteplase (9 U) and Maximum dose (18 U) in acute ischemic stroke patients.

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2023-06-12
• Last updated: 2024-04-09

Regulatory

• FDA-regulated drug study