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Effecacy and safety of intra-arterial infusion of urokinase to reduce fultile recanalization after successful interventional recanalization of acute cerebral infarction with anterior circulation large vessel occlusion

Effecacy and safety of intra-arterial infusion of urokinase to reduce fultile recanalization after successful interventional recanalization of acute cerebral infarction with anterior circulation large vessel occlusion - FINAL-UK Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066426
Enrollment
Unknown
Registered
2022-12-05
Start date
2022-12-10
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute cerebral infarction

Interventions

Control group:Intra-arterial non infusion of urokinase
Test group:Intra-arterial infusion of urokinase

Sponsors

Heyuan People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1) Age >= 18 years; 2) The time from onset to intra-arterial infusion of urokinase was within 24 hours; 3) CTA/MRA confirmed that it was an occlusive stroke of large vessels in the anterior circulation (M1 or M2 occlusion of internal carotid artery or middle cerebral artery), and it was the responsible vessel for signs and symptoms of acute ischemic stroke; 4) NIHSS score = 6 points; 6h = time from onset to treatment = 7 points or meet DIFUSSE 3 research standard (low perfusion volume/infarct core>1.8 and maximum infarct core = 80 years: NIHSS >= 10, infarct volume= 10, infarct volume= 20, infarct volume 31-51ml); 6) After endovascular treatment, eTICI should reach at least 2b level and above; 7) The patient or family member shall sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1) Intracranial hemorrhage confirmed by head CT or MRI; 2) Receiving intravenous thrombolytic therapy; 3) mRS score >= 2 before onset; 4) DSA angiography during the operation showed vascular perforation, dissection, contrast agent extravasation or bleeding; 5) Pregnant or lactating women; 6) Hypersensitivity to contrast agents; 7) Is participating in other clinical trials; 8) Intraoperative systolic blood pressure>180mmHg or diastolic blood pressure>105mmHg, and intravenous antihypertensive drugs cannot be controlled; 9) Genetics or acquired hemorrhagic constitution, lack of anticoagulant factor; Or oral anticoagulant with INR>1.7; 10) Blood glucose22.2mmol/L (400mg/dl), and difficult to correct; Platelet220 µ Mol/L (2.5mg/dl) patients; 13) Life expectancy less than 6 months due to late stage of any disease; 14) The follow-up is not expected to be completed; 15) Intracranial aneurysm, arteriovenous malformation; 16) Brain tumor with space occupying effect on imaging; 17) The time from puncture to recanalization is greater than 90 min; 18) The number of stent thrombus removal>3 times, the number of suction>3 times, and the number of balloon expansion>3 times; 19) Intraarterial infusion of tirofiban injection > 8ml during operation.

Design outcomes

Primary

MeasureTime frame
90 days mRS score 0 - 2 points;

Secondary

MeasureTime frame
90 days mRS score 0-1;Improvement degree of 90 day mRS score;Changes of NIHSS score 5-7 days after operation;90 day recurrence rate of cerebral infarction;90 day EQ-5D-5L scale score;

Countries

China

Contacts

Public ContactWensheng Zhang

Heyuan People's Hospital

494172988@qq.com+86 18826401949

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026