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

Acute Ischemic Stroke Clinical Trial

— ATTIS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05604638
• Other study ID #: SecondAHGuangxiMU
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 31, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2022
• Source: Second Affiliated Hospital of Guangxi Medical University
• Contact: Shengliang Shi, MD
• Phone: +8613707888628
• Email: ssl_1964[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Intravenous thrombolysis with alteplase is recommended in treatment guidelines for patients with acute ischemic stroke. Previous studies showed that intravenous tenecteplase (0.25 mg/kg) is a reasonable alternative to alteplase for all patients presenting with acute ischemic stroke who meet standard criteria for thrombolysis. After thrombolysis-induced recanalisation, reocclusion occurs in 14-34% of patients, probably because of platelet activation. Early administration of antiplatelet therapy after intravenous thrombolysis could reduce the risk of reocclusion and improve outcome. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: December 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Tenecteplase plus Tirofiban
Patients will receive a continuous intravenous infusion of tirofiban at a rate of 0.1 µg/kg per minute for 26.5 h after start of tenecteplase treatment within 90 min
• Tenecteplase plus Placebo
Patients will receive a continuous intravenous infusion of Placebo at a rate of 0.1 µg/kg per minute for 26.5 h after start of tenecteplase treatment within 90 min

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Guangxi Medical University	CSPC Pharmaceutical Group Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional independence	mRS score, 0-2	90 days
Primary	mortality	mRS score, 6	90 days
Secondary	excellent functional outcome	mRS score, 0-1	90 days
Secondary	symptomatic intracranial hemorrhage		48 hours
Secondary	any intracranial hemorrhage		48 hours