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New treatment option for Ischemic Stroke
Official title Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)
ClinicalTrials.gov ID: NCT07283159
What this study is testing
What is Human Urinary Kallidinogenase?
Human Urinary Kallidinogenase is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ischemic stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Human urinary kallidinogenase (HUK) is a tissue kallikrein extracted from human urine. Under certain conditions, tissue kallikrein can convert kininogen into kallidin and kinins, thereby promoting vascular endothelial function, and exerting anti-inflammatory and antioxidant effects.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 year;
- Acute ischemic stroke confirmed by neuroimaging;
- The time from last known well to treatment is within 4.5 hours;
- NIHSS ≥ 6 at randomization;
- Received intravenous tenecteplase (0.25mg/kg);
You likely can't join if
- Planed for endovascular treatment;
- Use of Edaravone Injection, Edaravone Dexborneol Injection, Butylphthalide Injection or Capsules after the onset of the current episode；
- Prior use of ACE inhibitors within a period less than 5 half-lives before the intended administration of Urinary Kallidinogenase for Injection；
- Pregnancy；
- Allergy to the investigational drug(s)；
- Comorbidity with other serious diseases;
See the full eligibility criteria
- Age ≥ 18 year;
- Acute ischemic stroke confirmed by neuroimaging;
- The time from last known well to treatment is within 4.5 hours;
- NIHSS ≥ 6 at randomization;
- Received intravenous tenecteplase (0.25mg/kg);
- First stroke onset or past stroke without obvious neurological deficit (mRS≤1);
- Signed informed consent.
- Planed for endovascular treatment;
- Use of Edaravone Injection, Edaravone Dexborneol Injection, Butylphthalide Injection or Capsules after the onset of the current episode；
- Prior use of ACE inhibitors within a period less than 5 half-lives before the intended administration of Urinary Kallidinogenase for Injection；
- Pregnancy；
- Allergy to the investigational drug(s)；
- Comorbidity with other serious diseases;
- Participating in other clinical trials within 3 months;
- Patients not suitable for the study considered by researcher.
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenyang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.