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

NCT ID: NCT06848894

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2027-12-31

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.

Detailed Description

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Human urinary kallidinogenase (HUK)

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Human urinary kallidinogenase (HUK)

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years.

2. Having anterior circulation AIS within 24 hours of onset.

3. The NIHSS score at enrollment is 4 to 25.

4. 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.

5. Being independent in daily activities (mRS ≤1) before onset.

6. Patients or their legal representatives are able and willing to sign informed consent forms.

Exclusion Criteria

1. Having an Alberta Stroke Program Early Computed Tomography Score (ASPECT) score of 6 or less confirmed by preoperational computed tomography scan.

2. Being already treated with HUK or any drugs containing HUK after onset.

3. Having an allergy history of HUK or drugs containing HUK, or other drugs and food.

4. 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.

5. Taking angiotensin-converting enzyme inhibitor (ACEI) antihypertensive drugs regularly within one week before enrollment, including captopril, enalapril, benazepril, etc.

6. 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).

7. Having severe cardiopulmonary disease that are deemed unsuitable for the study by the investigators.

8. Having contraindications for intravenous thrombolysis or endovascular treatment, including intra-arterial thrombolysis, mechanical thrombectomy, or intravenous rt-PA /TNK-tPA bridging endovascular treatment.

9. Having lethal diseases with a life expectancy < 3 months.

10. Being pregnant or lactating; or women of child-bearing age not taking effective contraception, or having no negative pregnancy test record.

11. Being unable to complete the study due to mental illness, cognitive or emotional disorder, physical condition, geographical factors, etc.

12. Participating in another clinical trial currently.

13. Other conditions that investigators consider he/she is not appropriate to participate in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

yilong Wang

Executive Vice-President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wang Yilong, MD, PhD

Role: STUDY_CHAIR

Beijing Tiantan Hospital

Wang Tingting, MD

Role: STUDY_DIRECTOR

Beijing Tiantan Hospital

Locations

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wang Yilong, MD, PhD

Role: CONTACT

yilong528@aliyun.com

0086-010-59976274

Wang Tingting, MD

Role: CONTACT

wangtingtingdr@sina.com

0086-18810956596

Facility Contacts

Wang Yilong, MD, PhD

Role: primary

yilong528@aliyun.com

0086-010-59976274

Wang Tingting, MD

Role: backup

wangtingtingdr@sina.com

0086-18810956596

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Other Identifiers

KY2024-320-04

Identifier Type: -

Identifier Source: org_study_id