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Early combination treatment with tirofiban following intravenous thrombolysis in acute ischemic stroke: a multicenter, prospective, cohort study

Early combination treatment with tirofiban following intravenous thrombolysis in acute ischemic stroke: a multicenter, prospective, cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400089090
Enrollment
Unknown
Registered
2024-09-02
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-09-09

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

Conditions

Ischemic stroke

Interventions

Standard Medical Therapy plus Intravenous Tirofiban Group:NA

Sponsors

Second Affiliated Hospital of Army Medical University, PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Age = 18 years; 2) Initial diagnosis of acute ischemic stroke based on clinical symptoms or imaging examinations; 3) Intracranial non-large to medium vessel occlusive stroke confirmed by cranial CTA/MRA/DSA (Large to medium vessel occlusive stroke defined as: intracranial segment of the internal carotid artery, M1-M3 segments of the middle cerebral artery, A1-A3 segments of the anterior cerebral artery, V4 segment of the vertebral artery, basilar artery, and P1-P3 segments of the posterior cerebral artery); 4) Have received intravenous alteplase or tenecteplase thrombolysis within 4.5 hours of onset; 5) Still have disabling stroke (defined as NIHSS score > 5) 2 hours after the end of intravenous thrombolysis, regardless of whether or not they received intravenous tirofiban treatment; 6) Signed written informed consent by the patient or their family.

Exclusion criteria

Exclusion criteria: 1) Intracranial hemorrhage confirmed by head CT or MRI; 2) Pre-stroke mRS score = 2; 3) Pregnant or breastfeeding women; 4) Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, and uncontrolled by antihypertensive medication; 5) Cardioembolic stroke or potential cardioembolic thrombosis with any of the following clear sources of cardiac embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac thrombus or implant, dilated cardiomyopathy, left atrial spontaneous echo contrast; 6) Genetic or acquired hemorrhagic diathesis, anticoagulation factor deficiency; or use of anticoagulants with an INR > 1.7; 7) Blood glucose 22.2 mmol/L, platelet count 220 µmol/L); 10) Any terminal illness with an expected survival of less than 6 months; 11) Expected inability to complete follow-up; 12) Intracranial aneurysm or arteriovenous malformation; 13) Intracranial mass lesion; 14) Interval time from the end of intravenous thrombolysis to tirofiban treatment exceeds 24 hours.

Design outcomes

Primary

MeasureTime frame
excellent outcomes;

Secondary

MeasureTime frame
Global Outcome Score;favorable outcomes;symptomatic intracranial hemorrhage;asymptomatic intracranial hemorrhage;death;NIHSS score change at 24hours after IVT;NIHSS score change at 5-7 days;Change of Infarct Volume;Imaging 72 hour (± 24 hours) Infarct Volume;Serious Adverse Events;

Countries

China

Contacts

Public ContactWenjie Zi

Second Affiliated Hospital of Army Medical University, PLA

Ziwenjie1981@163.com+86 182 0519 2720

Outcome results

None listed

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