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

RecruitingPhase 3Ages 18 Years - anyAllSecond Affiliated Hospital of Guangxi Medical Uni…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥ 18 years old; 2. Within 4-24 hours after intravenous thrombolytic therapy with tenerplase for acute ischemic stroke, there was no significant change in symptoms compared to the baseline (defined as an increase or decrease of 0 or 1 point in the NIHSS score), and neurological function deteriorated (defined as an increase of ≥ 2 in the NIHSS score compared to the baseline) Fluctuations in neurological function (defined as an increase of 4 points or more in the NIHSS score compared to the baseline and then a decrease of 4 points or more); 3. NIHSS ≥ 4 points before randomization; 4. The patient or their family members sign a written informed consent form. Exclusion Criteria: 1. Intracranial hemorrhage was confirmed by CT or MRI after intravenous thrombolysis and before randomization; 2. CTA/MRA/DSA showed occlusion of the internal carotid artery, middle cerebral artery M1, M2 or M3 segment, anterior cerebral artery A1, A2 or A3 segment, posterior cerebral artery P1, P2 or P3, vertebral or basilar artery; 3. Confirmed or suspected cardioembolic stroke mechanisms, including any of the following: documented cardiac sources of thromboembolism: chronic or paroxysmal atrial fibrillation, rheumatic mitral stenosis, prosthetic heart valves, infective endocarditis, intracardiac thrombus or implanted prosthetic material, dilated cardiomyopathy (left ventricular ejection fraction \<40%), or spontaneous echo contrast in the left atrium; other laboratory-confirmed embolic sources: patent foramen ovale with concomitant atrial septal aneurysm, or cryptogenic stroke with a CHADS-VASC score ≥ 2 indicating high thromboembolic risk; 4. Blood platelet count was lower than 100×10\^9/L; 5. Renal insufficiency, glomerular filtration rate \< 30 mL/min; 6. Pregnant or lactating women; 7. Allergic to tirofiban, nickel, titanium or their alloys; 8. Prior neurological or psychiatric illness that prevents assessment of neurological function; 9. Pre-existing bleeding disease, severe heart, liver, or kidney disease, or sepsis; 10. Brain tumors with a space-occupying effect on imaging (other than micromeningiomas); 11. Intracranial aneurysm, arteriovenous malformation; 12. Life expectancy of any advanced disease \< 6 months; 13. Participating in other clinical trials.
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What it tests

  • Tirofiban Hydrochloride
  • Placebo
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Where

38 sites
Mingguang People's Hospital
Chuzhou, China
Longyan People´s Hospital, Longyan City
Longyan, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, China
Huangmei People's Hospital
Huanggang, China
Yiling People's Hospital of Yichang city
Yichang, China
Hunan Xupu Chengnan Hospital
Huaihua, China
People's Hospital Of Shaodong
Shaoyang, China
Shaoshan People's Hospital
Xiangtan, China

…and 30 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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