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Evaluation of the Efficacy and Safety of Tirofiban in the Treatment of Acute Ischemic Stroke with Non-large Vessel Occlusion beyond the Intravenous Thrombolysis Time Window

Evaluation of the Efficacy and Safety of Tirofiban in the Treatment of Acute Ischemic Stroke with Non-large Vessel Occlusion beyond the Intravenous Thrombolysis Time Window

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110182
Enrollment
Unknown
Registered
2025-10-10
Start date
2025-10-10
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Acute Ischemic Stroke

Interventions

Tirofiban group( observation group):An initial loading dose of 0.4 µg/kg/min is administered intravenously for 30 minutes (with a total dose not exceeding 1 mg), followed by a continuous intravenous i
Oral medication group (control group):Conventional oral antiplatelet aggregation drugs (aspirin 100mg/day or clopidogrel 75mg/day or other oral antiplatelet aggregation regimens).

Sponsors

Bozhou People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age range: over 18 years old. 2.patients diagnosed with ischemic stroke, conforming to the WHO diagnostic criteria for stroke; 3. The time from onset or symptom onset to seeing a doctor was 4.5 to 24 hours; For those with an unknown time of onset, the time of symptom onset was defined as the "last time it appeared normal." 4. Ischemic stroke caused by non-large vessel acute occlusion confirmed by head CTA or MRA; 5.NIHSS score >=4; 6. Patients voluntarily participated and signed informed consent.

Exclusion criteria

Exclusion criteria: 1.According to the TOAST classification, the etiology of stroke was cardiogenic according to the medical history and imaging examination. 2. Intracranial hemorrhage confirmed by head CT or MRI; 3. Thrombolysis with urokinase; 4. Allergy to tirofiban or contraindication to tirofiban; 5. Women who are currently pregnant or breastfeeding; 6. History of gastrointestinal or urethral bleeding within the past 30 days; 7. Underwent major surgical procedures within the past 2 weeks; 8. Previous history of heparin-induced thrombocytopenia; 9. The presence of any serious medical condition that may lead to a life expectancy of less than 6 months; 10. The presence of a previous neurological or psychiatric disorder or other condition that may affect the assessment of the patient's neurological function during the trial; 11. Platelet count on admission was less than 100*10^9/L; 12. Severe renal insufficiency; 13. Inability to complete 90-day follow-up.

Design outcomes

Primary

MeasureTime frame
The proportion of Early Neurological Deterioration(END) occurrences;BARC type 2, 3 or 5 bleeding within 3 months;All bleeding events within 3 months (defined as BARC bleeding grades 1-5);

Secondary

MeasureTime frame
The proportion of good prognosis of neurological function at 90 days;Shift analysis of mRS score at 90 days;The variations in National Institute of Health Stroke Scale (NIHSS) scores at 24 hours post - treatment, 5 - 7 days after treatment, or upon discharge.;The scores of the EQ - 5D - 5L scale at 90 days;The Barthel Index scores at 90 days;The mortality rate at 90 days;

Countries

China

Contacts

Public ContactZhang Bin

Department of Neurology, Bozhou People's Hospital

2993225085@qq.com+86 558 567 5808

Outcome results

None listed

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