rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window

Recruiting Phase 3 Interventional Study
Acute Ischemic Stroke
No Placebo Group Every participant receives an active treatment — no one gets a placebo. 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
750 (estimated)
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Other
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About This Trial

The PEARL-SIMPLIFIED trial is a multicenter, prospective, randomized controlled, open-label, blinded-endpoint study. It aims to evaluate the efficacy and safety of intravenous tenecteplase (TNK) in patients with acute ischemic stroke (AIS) presenting in the extended 4.5-24 hour window, using a simplified imaging selection strategy based solely on non-contrast CT (NCCT).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age 18 years or older. 2. Presumed acute ischemic stroke of the anterior circulation. 3. Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrollment; including wake-up stroke and unwitnessed stroke, onset time refers to 'last-known well time'. 4. Baseline …
Contacts

Jinyuan Wang

86-18558992193

wangjy257@mail2.sysu.edu.cn

CONTACT

Xinguang Yang, MD, PhD

yangxinguang0926@163.com

CONTACT