Endovascular Treatment With or Without Preceding Intravenous Tenecteplase (TNK) in Patients With Late-window acUte Ischemic Stroke Due to Middle Cerebral Artery Occlusion: a Multi-center, Prospective, Randomized, Open-label, Blinded Endpoint (PROBE), Phase 3 Trial
Overview
- Phase
- Phase 3
- Intervention
- Tenecteplase
- Conditions
- Ischemic Stroke, Acute
- Sponsor
- Beijing Tiantan Hospital
- Enrollment
- 391
- Locations
- 21
- Primary Endpoint
- The modified Rankin Scale (mRS) score 0 to 2 at 90 days
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
The purpose of this study is to investigate the safety and efficacy of endovascular treatment with or without preceding intravenous Tenecteplase in patients with late-window (4.5-24 hours of symptom onset) acute ischemic stroke due to middle cerebral artery (MCA) M1 or proximal M2 occlusion.
Detailed Description
After being informed about the study and potential risks, patients who meet the inclusion criteria will be randomized to endovascular treatment with preceding intravenous Tenecteplase (0.25mg/kg, maximum 25mg) or without preceding intravenous Tenecteplase in a 1:1 ratio. Written informed consent will be needed.
Investigators
Yunyun Xiong
Professor
Beijing Tiantan Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
IVT with Tenecteplase+EVT
Tenecteplase 0.25mg/kg: 1-2 vials (1.0×107 IU/16 mg per vial) Each vial of Tenecteplase is reconstituted with 3 ml sterile water for injection and adjusted to a concentration of 5.33 mg/ml. The total amount of drug will be calculated according to the subject's actual body weight and the required drug volume will be measured. The maximum dose should not exceed 25mg. Tenecteplase should be given as a single, intravenous bolus (drug administered over 5-10 seconds). Endovascular treatment (EVT) should be performed as soon as possible after Tenecteplase administration.
Intervention: Tenecteplase
Direct EVT
During the study period, NMPA-approved stents are permitted. EVT included thrombectomy with stent retrievers, thromboaspiration, intraarterial thrombolysis, balloon angioplasty, stenting, or a combination of these approaches at the discretion of the interventional team.
Intervention: direct EVT
Outcomes
Primary Outcomes
The modified Rankin Scale (mRS) score 0 to 2 at 90 days
Time Frame: 90 days
The proportion of the modified Rankin Scale (mRS) score 0 to 2 at 90 days. Scores on the mRS range from 0 to 6, with higher scores indicating greater disability.
Secondary Outcomes
- Ordinal shift analysis of mRS at 90 days (not combined mRS 5 and 6)(90 days)
- mRS 0-1 at 90 days(90 days)
- mRS 0-3 at 90 days(90 days)
- mRS 5-6 at 90 days(90 days)
- NIHSS≤1 or a decrease of 8 points or more from baseline at 72h after randomization(72 hours)
- Change in stroke severity (NIHSS score) at 7 days after randomization from baseline(7 days)
- Successful reperfusion prior to endovascular treatment by DSA (eTICI 2b50-3)(0 hours (at treatment time))
- Complete recanalization according to CTA or MRA performed 24 hours after randomization(24 hours)
- Good reperfusion at 24h after randomization(24 hours)