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A randomized clinical trial of early administration of tirofiban in patients treated with intravenous thrombolysis for acute ischemic stroke

A randomized clinical trial of early administration of tirofiban in patients treated with intravenous thrombolysis for acute ischemic stroke

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087813
Enrollment
Unknown
Registered
2024-08-05
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

acute ischemic stroke

Interventions

Experimental group:Intravenous thrombolysis + tirofiban + standard medication
Control group:Intravenous thrombolysis + standard medication

Sponsors

The Second Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Aged over 18 years old; 2) Acute ischemic stroke according to clinical symptoms or imaging examination; 3) Cerebral CTA/MRA/DSA was confirmed as intracranial non-medium and large vascular occlusive stroke (medium and large vascular occlusive stroke was defined as: intracranial carotid artery segment M1-M3, anterior cerebral artery segment A1-A3, vertebral artery segment V4, basilar artery and posterior cerebral artery segment P1-P3); 4) Agreed with and performed intravenous alteplase or teneplase thrombolysis within 4.5 hours of onset; 5) Disabling stroke remained 2 hours after the end of intravenous thrombolysis (defined as disabling stroke :NIHSS score >5); 6) Skull imaging after intravenous thrombolysis to exclude intracranial hemorrhage; 7) From the end of intravenous thrombolysis to the randomization time within 24h; 8) Written informed consent signed by the patient or family.

Exclusion criteria

Exclusion criteria: 1) Intracranial hemorrhage was confirmed by head CT or MRI; 2) Pre-onset mRS Score >= 2; 3) Pregnant or lactating women; 4) Systolic blood pressure >185mmHg or diastolic blood pressure >110mmHg, and antihypertensive drugs can not control; 5) Cardiogenic stroke or potential cardiogenic thrombosis, with any of the following definite causes of cardiac embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valves, endocarditis, intracardiac thrombosis or implants, dilated cardiomyopathy, left atrial spontaneous acoustic imaging; 6) Genetics or acquired bleeding constitution, lack of anticoagulation factors; Or have used anticoagulants and INR>1.7; 7) Blood glucose 22.2mmol, platelet 220umol/L); 10) Life expectancy of <6 months due to the advanced stage of any disease; 11) The follow-up is not expected to be completed; 12) Intracranial aneurysm, arteriovenous malformation; 13) Intracranial space-occupying lesions; 14) Allergic to Tirofiban and contrast agents; 15) Participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Early neurological deterioration within 72 hours of randomization, defined as an increase of >= 4 points in the NIHSS score at any time within 72 hours compared to before randomization;Symptomatic intracranial hemorrhage within 72 hours of randomization;

Secondary

MeasureTime frame
Early neurological deterioration, defined as an increase of >= 2 points in the NIHSS score at any time within 72 hours compared to pre-randomization;Early improvement, defined as a decline of >= 4 points in the NIHSS score at any time within 72 hours compared to pre-randomization;Disability level at 90 days;Excellent neurological outcomes at 90 days (mRS 0-1);Functional independence at 90 days (mRS 0-2 points);Changes in NIHSS scores from baseline to 24 hours, 72 hours, and 7 days;

Countries

China

Contacts

Public ContactKong Deyan

The Second Affiliated Hospital of Guangxi Medical University

kongdeyangxnn@163.com+86 183 7663 5080

Outcome results

None listed

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