Overview

Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke

Status:
Not yet recruiting
Trial end date:
2025-12-31
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to assess the safety and efficacy of early administration of tirofiban in patients treated with tenecteplase for acute ischemic stroke.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Second Affiliated Hospital of Guangxi Medical University
Collaborator:
CSPC Pharmaceutical Group Limited
Treatments:
Tenecteplase
Tirofiban
Criteria
Inclusion Criteria:

Age 18-80 years Ischemic stroke with measurable deficit on NIH Stroke Scale Treatment
within 4.5 hours of stroke onset Be able to engage in daily life independently before the
onset of this ischemic stroke (mRS score: 0-1) Patients awakening with symptoms are defined
by the time last observed normal Written informed consent by patient or proxy

Exclusion Criteria:

Patients with premorbid modified Rankin Scale (mRS) score ≥3 Patients for whom a complete
NIH Stroke Score cannot be obtained Hemiplegic migraine with no arterial occlusion on CTA
Seizure at stroke onset and no visible occlusion on baseline CTA Intracranial haemorrhage
on baseline CT Clinical presentation suggesting subarachnoid haemorrhage even if baseline
CT is normal Large areas of hypodense ischaemic changes on baseline CT Patients with
systolic blood pressure >185 mm Hg or diastolic blood pressure >110 mm Hg Female, pregnant
or breast feeding Known bleeding diathesis Known allergic to tirofiban or other
glycoprotein IIb/IIIa antagonist Use of oral anticoagulants and International Normalized
Ratio (INR) ≥1,4 Use of new oral anticoagulants (NOAC) within the last 12 hours Heparin <48
hours and increased Activated partial thromboplastin tike (APTT) Low molecular weight
heparin(oid) <24 hours Any other investigational drug <14 days Sepsis Patients with
arterial puncture at a noncompressible site or lumbar puncture <7 days Major surgery or
serious trauma <14 days Gastrointestinal or urinary tract hemorrhage <14 days Clinical
stroke <2 months History of intracranial haemorrhage Brain neurosurgery <2 months Serious
head trauma <2 months Pericarditis Any serious medical illness likely to interact with
treatment Confounding pre-existent neurological or psychiatric disease Unlikely to complete
follow-up Pregnancy