Beijing Tia Ntanhospital
yoBoletus Wang
The trial is a phase 3, multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled design. Patients with acute ischemic stroke due to anterior circulation large vessel occlusion within 4.5-24 hours from last known well (including wake-up stroke and unwitnessed stroke) will be randomized 1:1 to 0.25mg/kg intravenous tenecteplase or standard medical treatment.
Ischemic Stroke, Acute
tenecteplase (0.25 mg/kg, Max 25 mg)
standard medical treatment
Phase 3
The study will be a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE), controlled phase 3 trial (2 arms with 1:1 randomization) in ischemic stroke due to anterior circulation large vessel occlusion with perfusion mismatch up to 24 hours of symptom onset. The target mismatch profiles on CTP or MRI perfusion weighted imaging include ischemic core volume <70 mL, mismatch ratio≥1.8 and mismatch volume≥15 mL demonstrated by a certified automatic software. The minimum sample size is 516 patients.}}
Study Type : | Interventional |
Estimated Enrollment : | 516 participants |
Masking : | Single |
Primary Purpose : | Treatment |
Official Title : | A Phase 3, Multicenter, Prospective, Randomized, Open-label, Blinded-endpoint (PROBE) Controlled Trial of Tenecteplase Versus Standard Medical Treatment for Acute Ischemic Stroke Due to Anterior Circulation Large Vessel Occlusion With Perfusion Mismatch up to 24 Hours of Symptom Onset |
Actual Study Start Date : | January 19, 2022 |
Estimated Primary Completion Date : | January 29, 2024 |
Estimated Study Completion Date : | February 9, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: tenecteplase ( 0.25 mg/kg, Max 25 mg ) Tenecteplase (0.25 mg/kg) is given as a single, intravenous bolus (within 5-10 seconds) immediately upon randomization. Maximum dose 25mg. |
Drug: tenecteplase (0.25 mg/kg, Max 25 mg) |
Active Comparator: standard medical treatment Aspirin combined with clopidogrel, aspirin alone, or clopidogrel alone after randomization at the discretion of local investigators. |
Drug: standard medical treatment |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing, China, 100000