Health TrialsbyHealthPanel

Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS)

ConditionIschemic Stroke
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneral Hospital of Shenyang Military Region

About this trial

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. Preclinical and clinical studies have demonstrated that HUK can salvage the ischemic penumbra and significantly promote the establishment of collateral circulation. Existing research suggests that the combination of HUK with intravenous alteplase significantly improves neurological function in patients with acute ischemic stroke (AIS) without increasing the risk of hemorrhage. However, whether its combination with tenecteplase can further enhance neurological recovery in patients remains unreported. Based on the above discussion, this study aims to investigate the efficacy and safety of combining tenecteplase with HUK in the treatment of AIS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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；

Trial design

Design model

Parallel

Treatments tested in this trial

  • Human Urinary Kallidinogenase

    Drug

    Human Urinary Kallidinogenase is administered intravenously, with 0.15 PNA units dissolved in 100 ml of normal saline.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: experimental groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

proportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1)

The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

Time frame
90±7 days

Secondary outcomes

1

proportion of modified Rankin Scale (mRS) 0-2

The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

Time frame
90±7 days
2

ordinal distribution of modified Rankin Scale (mRS)

The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

Time frame
90±7 days
3

change in National Institute of Health stroke scale (NIHSS) score

the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome

Time frame
24 (-6/+12) hours
4

change in National Institute of Health stroke scale (NIHSS) score

the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome

Time frame
10±2 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

General Hospital of Shenyang Military Region

Lead sponsor

Source ClinicalTrials.gov
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