NCT05604638Toboroz3. fázis
Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke
Safety and Efficacy of Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 24.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 348 (tervezett)
- Első benyújtás
- 2022. okt. 28.
- Kezdés
- 2024. ápr. 24.
- Elsődleges befejezés
- 2025. dec. 31.
- Fő szponzor
- Second Affiliated Hospital of Guangxi Medical University
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT05604638
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 3. fázis
- Tervezett résztvevők: 348
- 2024. ápr. 24. és az elsődleges befejezés (2025. dec. 31.) között
- 38 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- Prior neurological or psychiatric illness that prevents assessment of neurological function;
Más betegség
- Intracranial hemorrhage was confirmed by CT or MRI after intravenous thrombolysis and before randomization;
- Renal insufficiency, glomerular filtration rate < 30 mL/min;
- Allergic to tirofiban, nickel, titanium or their alloys;
- Pre-existing bleeding disease, severe heart, liver, or kidney disease, or sepsis;
- Life expectancy of any advanced disease < 6 months;
Laborértékek
- 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;
- Blood platelet count was lower than 100×10\^9/L;
Egyéb
- 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;
- Pregnant or lactating women;
- Brain tumors with a space-occupying effect on imaging (other than micromeningiomas);
- Intracranial aneurysm, arteriovenous malformation;
- Participating in other clinical trials.
Kiket keres a vizsgálat
- Age ≥ 18 years old;
- 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);
- NIHSS ≥ 4 points before randomization;
- The patient or their family members sign a written informed consent form.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (38)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Zhongmeng Hospital of Hexigten Banner | Chifeng | Kína | Toboroz |
| Mingguang People's Hospital | Chuzhou | Kína | Toboroz |
| Dalian Municipal Central Hospital | Dalian | Kína | Toboroz |
| People's Hospital of Xunwu County | Ganzhou | Kína | Toboroz |
| Traditional Chinese Medicine Hospital of Yudu County | Ganzhou | Kína | Toboroz |
| The People's Hospital of Ningdu County | Ganzhou | Kína | Toboroz |
| Traditional Chinese Medicine Hospital of Xingguo County | Ganzhou | Kína | Toboroz |
| People's Hospital of Shicheng County | Ganzhou | Kína | Toboroz |
| People's Hospital of Anyuan County | Ganzhou | Kína | Toboroz |
| People's Hospital of RuiJin City | Ganzhou | Kína | Toboroz |
| People's Hospital of Shangyou County | Ganzhou | Kína | Toboroz |
| People's Hospital of Ganxian District | Ganzhou | Kína | Toboroz |
| People's Hospital of Yudu County | Ganzhou | Kína | Toboroz |
| Ganzhou Municipal Hospital | Ganzhou | Kína | Toboroz |
| People's Hospital of Quannan County | Ganzhou | Kína | Toboroz |
| People's Hospital of Chongyi County | Ganzhou | Kína | Toboroz |
| Ganzhou People's Hospital | Ganzhou | Kína | Toboroz |
| Second People's Hospital of Yudu County | Ganzhou | Kína | Toboroz |
| Second Hospital of Xingguo County | Ganzhou | Kína | Toboroz |
| Nankang TCM Hospital | Ganzhou | Kína | Toboroz |
| People's Hospital of Dayu County | Ganzhou | Kína | Toboroz |
| People's Hospital of Xinfeng County | Ganzhou | Kína | Toboroz |
| Hunan Xupu Chengnan Hospital | Huaihua | Kína | Toboroz |
| Huangmei People's Hospital | Huanggang | Kína | Toboroz |
| People's Hospital of Wan'an county | Ji’an | Kína | Toboroz |
| Ji'an Central People's Hospital | Ji’an | Kína | Toboroz |
| Affiliated Hospital of Jiujiang University | Jiujiang | Kína | Toboroz |
| Longyan People´s Hospital, Longyan City | Longyan | Kína | Toboroz |
| Jiangxi Provincial People's Hospital | Nanchang | Kína | Toboroz |
| The Second Affiliated Hospital of Guangxi Medical University | Nanning | Kína | Toboroz |
| People's Hospital Of Shaodong | Shaoyang | Kína | Toboroz |
| Songyuan Jilin Oilfield Hospital | Songyuan | Kína | Toboroz |
| Xiangtan Central Hospitall | Xiangtan | Kína | Toboroz |
| Shaoshan People's Hospital | Xiangtan | Kína | Toboroz |
| Yiling People's Hospital of Yichang city | Yichang | Kína | Toboroz |
| People's Hospital of Yichun | Yichun | Kína | Toboroz |
| Yingtan People's Hospital | Yingtan | Kína | Toboroz |
| Hunan University of Medicine Affiliated Pingjiang Hospital | Yueyang | Kína | Toboroz |
Kapcsolódó publikációk
- Intravenous Tirofiban After Tenecteplase in Acute Ischemic Stroke: The INSTANT Randomized Clinical Trial.JAMA · 2026 · PMID 42100960
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