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NCT Number: NCT06848894

Efficacy and Safety of Human Urinary Kallidinogenase for Acute Ischemic Stroke Patients Receiving Reperfusion Treatment

This study aims to explore the efficacy and safety of Human Urinary Kallidinogenase for acute ischemic stroke patients receiving intravenous thrombolysis and/or endovascular treatment.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

Wang Tingting, MD

CONTACT

[email protected]

0086-18810956596

Wang Tingting, MD

SUB_INVESTIGATOR

Wang Yilong, MD, PhD

CONTACT

[email protected]

0086-010-59976274

Wang Yilong, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

Within 24 hours after symptom onset, eligible participants will be randomly assigned in a 1:1 ratio to the HUK or placebo group, receiving adjunctive HUK or placebo treatment alongside standard intravenous thrombolysis and/or endovascular treatment. All participants will be recommended to continuously inject drugs or placebo for 10 to 14 days according to length of hospitalization.

  • Intervention group: HUK (0.15 PNA) and sodium chloride injection (100ml), once per day
  • Control group: placebo (0 PNA) and sodium chloride injection (100ml), once per day The total follow-up duration is 90 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years.
  • Having anterior circulation AIS within 24 hours of onset.
  • The NIHSS score at enrollment is 4 to 25.
  • Receiving intravenous recombinant tissue plasminogen activator (rt-PA) or TNK-tPA, or endovascular treatment including intra-arterial thrombolysis, mechanical thrombectomy, or intravenous rt-PA /TNK-tPA bridging endovascular treatment.
  • Being independent in daily activities (mRS ≤1) before onset.
  • Patients or their legal representatives are able and willing to sign informed consent forms.

Exclusion criteria

  • Having an Alberta Stroke Program Early Computed Tomography Score (ASPECT) score of 6 or less confirmed by preoperational computed tomography scan.
  • Being already treated with HUK or any drugs containing HUK after onset.
  • Having an allergy history of HUK or drugs containing HUK, or other drugs and food.
  • Having a history of coagulation dysfunction, systemic bleeding, or thrombocytopenia; having hemorrhagic diseases at the time of enrollment, including cerebral hemorrhage, subarachnoid hemorrhage, epidural or subdural hematoma, gingival bleeding, gastrointestinal bleeding, dermal ecchymosis, etc; taking anticoagulants including warfarin, rivaroxaban, etc.; or taking heparin within 48 hours after stroke onset.
  • Taking angiotensin-converting enzyme inhibitor (ACEI) antihypertensive drugs regularly within one week before enrollment, including captopril, enalapril, benazepril, etc.
  • Having chronic liver disease or liver dysfunction, with elevated ALT/AST (>3.0×ULN ); or having kidney dysfunction or receiving dialysis, with elevated serum creatinine (>2.0×ULN).
  • Having severe cardiopulmonary disease that are deemed unsuitable for the study by the investigators.
  • Having contraindications for intravenous thrombolysis or endovascular treatment, including intra-arterial thrombolysis, mechanical thrombectomy, or intravenous rt-PA /TNK-tPA bridging endovascular treatment.
  • Having lethal diseases with a life expectancy < 3 months.
  • Being pregnant or lactating; or women of child-bearing age not taking effective contraception, or having no negative pregnancy test record.
  • Being unable to complete the study due to mental illness, cognitive or emotional disorder, physical condition, geographical factors, etc.
  • Participating in another clinical trial currently.
  • Other conditions that investigators consider he/she is not appropriate to participate in this study.

Treatment and study plan

Human urinary kallidinogenase (HUK)

Drug

HUK (0.15 PNA) and sodium chloride injection (100ml), once per day

Placebo

Drug

placebo (0 PNA) and sodium chloride injection (100ml), once per day

Primary outcomes

  1. Proportion of a favorable outcome (mRS 0-2)

    Time frame: at 90 days

    The proportion of a favorable outcome, defined by a modified Rankin Scale (mRS) score ranging from 0 to 2, reflects the percentage of patients who attained a functional status from no symptoms to mild disability, enabling them to perform all pre-stroke activities without assistance.

Secondary outcomes

  1. Proportion of a favorable outcome (mRS 0-2)

    Time frame: at 14 days

    The proportion of a favorable outcome, defined by a modified Rankin Scale (mRS) score ranging from 0 to 2, reflects the percentage of patients who attained a functional status from no symptoms to mild disability, enabling them to perform all pre-stroke activities without assistance.

  2. Proportion of an excellent outcome (mRS 0-1)

    Time frame: at 90 days

    The proportion of an excellent outcome, characterized by a modified Rankin Scale (mRS) score of 0 to 1, represents the percentage of patients who achieved a functional status from no symptoms to no significant disability despite symptoms, allowing them to resume all pre-stroke activities without any aid.

  3. Distribution of mRS score

    Time frame: at 90 days

    The distribution of modified Rankin Scale (mRS) scores provides a comprehensive overview of the functional outcomes across a patient population, categorizing the degree of disability from no symptoms (score 0) to severe disability or death (score 6).

  4. Improvement of NIHSS score

    Time frame: at 14 days

    The improvement of the National Institutes of Health Stroke Scale (NIHSS) score serves as a quantifiable measure of neurological recovery, reflecting the reduction in stroke-related deficits and the enhancement of patient functional capabilities over time. Minimum Score: 0 (no stroke symptoms) Maximum Score: 42 (severe stroke) Higher NIHSS scores indicate more severe stroke symptoms and are associated with worse outcomes.Lower NIHSS scores indicate milder stroke symptoms and are associated with better outcomes.

  5. Risk of recurrent symptomatic stroke

    Time frame: within 90 days

    The risk of recurrent symptomatic stroke quantifies the probability of a subsequent stroke event with clinical manifestations, providing a critical measure for assessing the long-term efficacy of stroke prevention strategies and the ongoing vulnerability of the patient population.

  6. Risk of recurrent symptomatic ischemic stroke

    Time frame: within 90 days

    The risk of recurrent symptomatic ischemic stroke delineates the likelihood of a subsequent ischemic stroke event accompanied by clinical symptoms, serving as a pivotal indicator for evaluating the effectiveness of secondary prevention measures and the persistent threat of cerebral ischemia in affected individuals.

  7. Risk of combined vascular events

    Time frame: within 90 days

    The risk of combined vascular events encompasses the probability of experiencing any major vascular incident, such as stroke, myocardial infarction, or vascular death, offering a comprehensive metric for assessing the overall burden of vascular disease and the aggregate impact of therapeutic interventions on cardiovascular health.

  8. Improvement of EQ-5D-5L

    Time frame: at 90 days

    The improvement of EQ-5D-5L(EuroQol 5-Dimension 5-Level) reflects an enhancement in health-related quality of life, as measured by gains across five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-on a five-level severity scale, indicating a positive shift in the patient's overall health state and well-being.

    Minimum Score: 0 (worst imaginable health state) Maximum Score: 100 (best imaginable health state) For the descriptive system, a lower score (closer to 11111) indicates better health-related quality of life, while a higher score (closer to 55555) indicates worse health-related quality of life.

    For the VAS, a higher score (closer to 100) indicates better self-rated health, while a lower score (closer to 0) indicates worse self-rated health.

  9. Improvement of MOCA

    Time frame: at 90 days

    The improvement of the Montreal Cognitive Assessment (MoCA) score signifies an enhancement in cognitive function, encompassing domains such as attention, memory, language, and executive functions, thereby indicating a positive progression in the patient's cognitive status and potential recovery from cognitive impairment.

    Minimum Score: 0 (severe cognitive impairment) Maximum Score: 30 (no cognitive impairment) Higher MoCA scores indicate better cognitive function. Lower MoCA scores indicate worse cognitive function.

Study contacts

Contact information is provided by the study sponsor or research team.

Wang Tingting, MD

CONTACT

[email protected]

0086-18810956596

Wang Yilong, MD, PhD

CONTACT

[email protected]

0086-010-59976274

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Acronym: UNITE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 27, 2025
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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