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

NCT06848894 | Recruiting DMC

• 1 other identifier: KY2024-320-04
• Study Type: interventional
• Target: 1,204
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Ischemic Stroke

Keywords

Human Urinary Kallidinogenase; Acute Ischemic Stroke; Reperfusion Treatment

Outcome Measures

Primary Outcomes (1)

• Proportion of a favorable outcome (mRS 0-2)

  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.

  at 90 days

Secondary Outcomes (9)

• Proportion of a favorable outcome (mRS 0-2)

  at 14 days

• Proportion of an excellent outcome (mRS 0-1)

  at 90 days

• Distribution of mRS score

  at 90 days

• Improvement of NIHSS score

  at 14 days

• Risk of recurrent symptomatic stroke

  within 90 days

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Drug: Human urinary kallidinogenase (HUK)

Control group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Human urinary kallidinogenase (HUK) DRUG

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

Intervention group

Placebo DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

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MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wang Yilong, MD, PhD

  Beijing Tiantan Hospital

  STUDY CHAIR

• Wang Tingting, MD

  Beijing Tiantan Hospital

  STUDY DIRECTOR

Central Study Contacts

Wang Yilong, MD, PhD

CONTACT

0086-010-59976274; yilong528@aliyun.com

Wang Tingting, MD

CONTACT

0086-18810956596; wangtingtingdr@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Vice-President

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 27, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)