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Safety and efficacy of adjunct tirofiban treatment after successful mechanical thrombectomy recanalization in acute anterior circulation ischemic stroke— A Multicenter, Prospective, Double-blind, Randomized Trial

Safety and efficacy of adjunct tirofiban treatment after successful mechanical thrombectomy recanalization in acute anterior circulation ischemic stroke— A Multicenter, Prospective, Double-blind, Randomized Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105242
Enrollment
Unknown
Registered
2025-07-01
Start date
2024-04-09
Completion date
Unknown
Last updated
2025-07-07

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

Conditions

acute ischemic stroke

Interventions

Control group:Placebo

Sponsors

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=18 years old; 2.NIHSS score: 6-30; 3.Onset of symptoms to 24h of randomization, including patients with wake-up stroke or unwitnessed stroke; The onset time of symptoms was defined as the last time of normal performance; 4.mRS 0-1 before the stroke; 5.Clinical symptoms caused by acute occlusion of the following sites confirmed by CTA or MRA: intracranial segment of ICA, M1 segment of middle cerebral artery, M2 trunk of middle cerebral artery; 6.ASPECTS>=6 on NCCT or DWI; 7.After the end of mechanical thrombectomy, the mTICI was stable at 2b/3 blood flow, and there was no secondary embolism in the blood supply area of other non-offending vessels, or the diagnostic angiography before mechanical thrombectomy showed that the occluded vessels improved to mTICI 2b/3, and no mechanical thrombectomy was planned; 8.Subjects or a legal representative were able to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Intra-arterial thrombolysis; 2. Tirofiban has been used within 24 hours before endovascular treatment; 3. Known pregnant or lactating females, or positive pregnancy test before randomization; 4. Allergy to tirofiban, radiocontrast agent or nitinol material; 5. Any active bleeding or recent bleeding (gastrointestinal, urinary tract bleeding, etc.) within 30 days before stroke; 6. Solid organ surgery and biopsy within 14 days before stroke; 7. History of heparin-induced thrombocytopenia; 8. Platelet count220µmol/L); 10. Subjects requiring hemodialysis or peritoneal dialysis, or subjects with contraindications to angiography for any reason; 11. The expected survival time is less than half a year (such as malignant tumors, severe cardiopulmonary diseases, etc.); 12. Have participated in other interventional clinical studies that may have an impact on outcome assessment; 13. Other conditions that in the opinion of the investigator are not suitable for participating in this study or may pose significant risks to the patient (such as inability to understand and/or obey the study procedures and/or follow-up due to mental disorders, cognitive or emotional disorders); 14. Midline displacement or herniation of the brain, ventricular mass effect; 15. CT or MRI showing acute intracranial hemorrhage; 16. New bilateral acute stroke or intracranial multi-basin large vessel occlusion; 17. Isolated extracranial segment occlusion of the internal carotid artery.

Design outcomes

Primary

MeasureTime frame
Proportion of sICH (Heidelberg criteria);The proportion of mRS 0-2;

Secondary

MeasureTime frame
mRS shift analysis;The proportion of mRS 0-1;The proportion of mRS 0-3;The proportion of patients with NIHSS score 0-1 or a reduction of =4 points from baseline;EQ-5D-5L scale score;All-cause mortality;Proportion of intracranial hemorrhage of any type (Heidelberg criteria);

Countries

China

Contacts

Public ContactXiang Luo

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology

flydottjh@163.com+86 27 83662677

Outcome results

None listed

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