Intravenous rhTNK-tPA Before Stroke Thrombectomy in the Extended Time Window

Recruiting Phase 3 Interventional Study
Stroke, Acute Ischemic
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
820 (estimated)
Sponsor
Xinqiao Hospital of Chongqing · Other
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About This Trial
This randomized, double-blind, placebo-controlled phase III clinical trial aims to evaluate the efficacy and safety of intravenous recombinant human tenecteplase (rhTNK-tPA) in acute ischemic stroke patients with large vessel occlusion presenting 4.5-24 hours after last known well. The study will address two primary questions: 1) Whether rhTNK-tPA enhances pre-thrombectomy reperfusion rates and im…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years; 2. Acute ischemic stroke presenting within 4.5-24 hours of last known well; 3. No significant pre-stroke functional disability: for age \<80 years, pre-stroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1; 4. Baseline NIHSS score ≥5; 5. Im…
Contacts

Zhongming Qiu, MD

13236599269

qiuzhongmingdoctor@163.com

CONTACT

Jing Lin, MD

15626456674

linjingsys2016@126.com

CONTACT