Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY)
Recruiting
Phase 3
Interventional Study
Ischemic Stroke, Acute
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.
At a Glance
- Age
- 18 – 100
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,380 (estimated)
- Sponsor
- Beijing Tiantan Hospital · Other
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About This Trial
Shuxuening injection is a multi-target neuroprotective agent, it is expected to play a neuroprotective role on the basis of intravenous thrombolysis therapy. The primary purpose of this multicenter, randomized, double-blind, placebo-parallel controlled trial is to evaluate the efficacy and safety of Shuxuening injection in the treatment with intravenous thrombolysis in patients with ischemic strok…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age 18 or older;
* Diagnosed with acute ischemic stroke;
* Within 6 hours of onset;
* Having received or plan to undergo intravenous thrombolytic therapy;
* NIHISS score of 4 to 25 points at enrollment;
* Signed informed consent.
Exclusion Criteria:
* mRS score greater than …
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