NCT06157502Toboroz3. fázis
Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke (SHINY)
Efficacy and Safety of Shuxuening Injection in the Treatment With Intravenous Thrombolysis in Patients With Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. júl. 24. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
Shuxuening injection is a multi-target neuroprotective agent, it is expected to play a neuroprotective role on the basis of intravenous thrombolysis therapy. The primary purpose of this multicenter, randomized, double-blind, placebo-parallel controlled trial is to evaluate the efficacy and safety of Shuxuening injection in the treatment with intravenous thrombolysis in patients with ischemic stroke.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 1380 (tervezett)
- Első benyújtás
- 2023. nov. 27.
- Kezdés
- 2024. jan. 11.
- Elsődleges befejezés
- 2025. dec. 31.
- Fő szponzor
- Beijing Tiantan Hospital
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT06157502
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 3. fázis
- Tervezett résztvevők: 1380
- 2024. jan. 11. és az elsődleges befejezés (2025. dec. 31.) között
- 82 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
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Receiving neuroprotective agents, such as edaravone, edaravone dextrocamphorol, butylphthalein, etc. after the onset;
Más betegség
- Bleeding or other pathological brain disorders, such as vascular malformations, tumors, abscesses, or other common non-ischemic brain diseases (such as multiple sclerosis), detected by CT/MRI;
- History of clotting disorders, systemic bleeding, thrombocytopenia, or neutropenia;
- Allergic to Shuxuening injection or preparations containing ginkgo biloba (ginkgo biloba extract);
Laborértékek
- Severe hepatic or renal insufficiency (severe hepatic insufficiency refers to the ALT or AST levels above 3 times the upper limit of normal; severe renal insufficiency refers to the creatinine levels above 2 times the upper limit of normal);
Életkor
- Women who are pregnant or breastfeeding, and women of childbearing age who have a negative pregnancy test but refuse to take effective contraceptive measures;
Egyéb
- mRS score greater than 1 point before the onset;
- Participation in another clinical trial with an experimental product during the last 30 days;
- Other participants deemed unsuitable for participation in this study by the investigator.
Kiket keres a vizsgálat
- Age 18 or older;
- Diagnosed with acute ischemic stroke;
- Within 6 hours of onset;
- Having received or plan to undergo intravenous thrombolytic therapy;
- NIHISS score of 4 to 25 points at enrollment;
- Signed informed consent.
Életkor a regiszterben: 18 év – 100 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (82)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Haicheng Hospital of Traditional Chinese Medicine | Anshan | Kína | Toboroz |
| Puyang Anyang District Hospital | Anyang | Kína | Toboroz |
| Baoding Xushui District People's Hospital | Baoding | Kína | Toboroz |
| The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology | Baotou | Kína | Toboroz |
| Fangshan District First Hospital | Beijing | Kína | Toboroz |
| Benxi Central Hospital | Benxi | Kína | Toboroz |
| Liuyang Jili Hospital | Changsha | Kína | Toboroz |
| Chenzhou First People's Hospital | Chenzhou | Kína | Toboroz |
| Chongqing Nanchuan District People's Hospital | Chongqing | Kína | Toboroz |
| Chongqing Sanbo Chang 'an Hospital | Chongqing | Kína | Toboroz |
| Xinhua Hospital Affiliated to Dalian University | Dalian | Kína | Toboroz |
| Dandong Central Hospital | Dandong | Kína | Toboroz |
| Ningjin People's Hospital | Dezhou | Kína | Toboroz |
| The First Affiliated Hospital of Guangdong Pharmaceutical University | Guangzhou | Kína | Toboroz |
| The Second Affiliated Hospital of Harbin Medical University | Harbin | Kína | Toboroz |
| Wuchang Hospital of Traditional Chinese Medicine | Harbin | Kína | Toboroz |
| Heyuan People's Hospital | Heyuan | Kína | Toboroz |
| Yuncheng People's Hospital | Heze | Kína | Toboroz |
| Tuquan People's Hospital | Hinggan | Kína | Toboroz |
| Inner Mongolia Hangtian Hospital | Hohhot | Kína | Toboroz |
| Huai'an Second People's Hospital | Huai'an | Kína | Toboroz |
| Zhalantun People's Hospital | Hulunbuir | Kína | Toboroz |
| Zalantun Zhongmeng Hospital | Hulunbuir | Kína | Toboroz |
| Jiaozuo Coal Industry (Group) Co. Ltd. Central Hospital | Jiaozuo | Kína | Toboroz |
| Mengzhou Hospital of Traditional Chinese Medicine | Jiaozuo | Kína | Toboroz |
| Wenxian People's Hospital | Jiaozuo | Kína | Toboroz |
| Shandong Provincial Public Health Clinical Center | Jinan | Kína | Toboroz |
| Jincheng People's Hospital | Jincheng | Kína | Toboroz |
| Jingmen Hospital of Traditional Chinese Medicine | Jingmen | Kína | Toboroz |
| Jingzhou First People's Hospital | Jingzhou | Kína | Toboroz |
| Yuci District People's Hospital | Jinzhong | Kína | Toboroz |
| The First Affiliated Hospital of Jinzhou Medical University | Jinzhou | Kína | Toboroz |
| Jiyuan Hospital of Traditional Chinese Medicine | Jiyuan | Kína | Toboroz |
| Kaifeng Central Hospital | Kaifeng | Kína | Toboroz |
| Lankao First Hospital | Kaifeng | Kína | Toboroz |
| Yunnan Third People's Hospital | Kunming | Kína | Toboroz |
| Liaocheng Third People's Hospital | Liaocheng | Kína | Toboroz |
| Guanxian People's Hospital | Liaocheng | Kína | Toboroz |
| Linfen People's Hospital | Linfen | Kína | Toboroz |
| Linfen Central Hospital | Linfen | Kína | Toboroz |
| Linshu People's Hospital | Linyi | Kína | Toboroz |
| Luohe Third People's Hospital | Luohe | Kína | Toboroz |
| Luoyang Yanshi People's Hospital | Luoyang | Kína | Toboroz |
| Huazhou People's Hospital | Maoming | Kína | Toboroz |
| Meizhou Hospital of Traditional Chinese Medicine | Meizhou | Kína | Toboroz |
| Wuming Hospital Affiliated to Guangxi Medical College | Nanning | Kína | Toboroz |
| Pingdingshan Second People's Hospital | Pingdingshan | Kína | Toboroz |
| Pingdingshan First People's Hospital | Pingdingshan | Kína | Toboroz |
| Nanle Zhongxing Hospital | Puyang | Kína | Toboroz |
| Chongqing Qianjiang Central Hospital | Qianjiang | Kína | Toboroz |
| Qinhuangdao Second Hospital | Qinhuangdao | Kína | Toboroz |
| Lingbao First People's Hospital | Sanmenxia | Kína | Toboroz |
| Xiayi People's Hospital | Shangqiu | Kína | Toboroz |
| Shangqiu Fourth People's Hospital | Shangqiu | Kína | Toboroz |
| Shangqiu First People's Hospital | Shangqiu | Kína | Toboroz |
| Suixian People's Hospital | Shangqiu | Kína | Toboroz |
| Yongcheng People's Hospital | Shangqiu | Kína | Toboroz |
| Suixian Hospital of Traditional Chinese Medicine | Shangqiu | Kína | Toboroz |
| Yongcheng Central Hospital | Shangqiu | Kína | Toboroz |
| Shangqiu Third Prople's Hospital | Shangqiu | Kína | Toboroz |
| Shaodong People's Hospital | Shaoyang | Kína | Toboroz |
| Shenyang First People's Hospital | Shenyang | Kína | Toboroz |
| The First Affiliated Hospital of Shihezi University Medical College | Shihezi | Kína | Toboroz |
| Tianjin Xiqing Hospital | Tianjin | Kína | Toboroz |
| Weihai Wendeng District People' Hospital | Weihai | Kína | Toboroz |
| Zhongnan Hospital of Wuhan University | Wuhan | Kína | Toboroz |
| Wuhan Fifth Hospital | Wuhan | Kína | Toboroz |
| Wuhan Huangpi District People's Hospital | Wuhan | Kína | Toboroz |
| Wuhan Central Hospital | Wuhan | Kína | Toboroz |
| Wuhan Hankou Hospital | Wuhan | Kína | Toboroz |
| The First Affiliated Hospital of Xi'an Jiao Tong University | Xi’an | Kína | Toboroz |
| The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | Kína | Toboroz |
| Huixian People's Hospital | Xinxiang | Kína | Toboroz |
| Yan'an University Affiliated Hospital | Yan’an | Kína | Toboroz |
| Yantai Yeda Hospital | Yantai | Kína | Toboroz |
| Yunfu People's Hospital | Yunfu | Kína | Toboroz |
| Wuchuan People's Hospital | Zhanjiang | Kína | Toboroz |
| Zhongshan People's Hospital | Zhongshan | Kína | Toboroz |
| The Fifth Affiliated Hospital of Sun Yat-sen University | Zhuhai | Kína | Toboroz |
| Zibo Municipal Hospital | Zibo | Kína | Toboroz |
| Wuchuan Gelao and Miao Autonomous County Hospital of Traditional Chinese Medicine | Zunyi | Kína | Toboroz |
| Zunyi First People's Hospital | Zunyi | Kína | Toboroz |
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