NCT04733742

Endovascular Treatment With Versus Without Intravenous rhTNK-tPA in Stroke

Intravenous rhTNK-tPA Bridging With Endovascular Treatment Versus Endovascular Treatment Alone For Stroke Patient With Large Vessel Occlusion: A Multicenter, Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 550 (actual)
• Sponsor: Xinqiao Hospital of Chongqing · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to investigate whether intravenous rhTNK-tPA prior to endovascular treatment can improve 90-day functional outcome of stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of symptom onset.

Detailed description

The DEVT, SKIP and DIRECT-MT trials showed that endovascular treatment alone is not inferior to intravenous alteplase bridging with endovascular treatment in terms of achieving 90-day functional independence for stroke patients with large vessel occlusion. The EXTEND-IA TNK part 1 and part 2 demonstrated that intravenous thrombolysis with tenecteplase is superior to alteplase before endovascular treatment. However, it is unclear whether intravenous tenecteplase bridging with endovascular treatment is superior to endovascular treatment alone. The purpose of this trial is to investigate whether intravenous rhTNK-tPA bridging with endovascular treatment is better than endovascular treatment alone for stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of onset.

Conditions

• Stroke, Acute
• Stroke, Ischemic

Interventions

Type	Name	Description
DRUG	rhTNK-tPA	intravenous thrombolysis with rhTNK-tPA followed by endovascular treatment
OTHER	Endovascular treatment	endovascular treatment

Timeline

• Start date: 2022-05-09
• Primary completion: 2024-12-16
• Completion: 2025-02-07
• First posted: 2021-02-02
• Last updated: 2025-04-03

Locations

6 sites across 1 country: China