Phase
Condition
Stroke
Cardiac Ischemia
Thrombosis
Treatment
Best medical management
Placebo
Aspirin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 years old;
Acute ischemic stroke treated with intravenous thrombolysis with alteplase ortenecteplase within 4.5 hours of onset or time last known well and can receive thestudy drug treatment within 3 hours of initiating intravenous thrombolysis.
NIHSS score improvement ≤ 2 points or worsening ≤ 4 points one hour after initiatingintravenous thrombolysis compared to pre-thrombolysis.
Residual NIHSS score > 5 points at randomization.
Informed consent obtained from patients or their acceptable surrogates.
Exclusion
Exclusion Criteria:
Stroke caused by definite large vessel occlusion (including A1 and A2 segments ofthe anterior cerebral artery, M1 and M2 segments of the middle cerebral artery, P1and P2 segments of the posterior cerebral artery, intracranial and extracranialsegments of the internal carotid artery, basilar artery, and bilateral vertebralartery occlusion) confirmed by imaging (including CTA or MRA).
Scheduled for endovascular treatment.
Intracranial hemorrhage confirmed by imaging post-thrombolysis.
Definite or suspected cardioembolic stroke.
Stroke caused by other determined causes, including moyamoya disease, arterydissection, arteritis, etc.
Pre-stroke mRS score > 1.
Severe consciousness disturbance with NIHSS item 1a (level of consciousness) ≥ 2points.
Post-thrombolysis imaging indicates an infarct area larger than 1/2 responsibleartery supply area.
Prior history of stroke events (manifesting as stroke symptoms, includinghemorrhagic stroke and ischemic stroke).
Known contraindications for antiplatelet therapy, such as coagulation disorders,systemic bleeding, etc.
History of aspirin allergy.
Use of antiplatelet or anticoagulant therapy within one week pre-stroke.
There is definite anticipation of developing indications for anticoagulant therapyduring the study period (e.g., atrial fibrillation, mechanical heart valve, deepvein thrombosis, pulmonary embolism, antiphospholipid syndrome, hypercoagulablestate).
Presence of malignant tumors, chronic hemodialysis, severe renal insufficiency (GFR < 30 ml/min or serum Cr > 220 μmol/L (2.5 mg/dl)), severe hepatic insufficiency (serum ALT > 2 times the upper limit of normal, or serum AST > 2 times the upperlimit of normal), severe heart failure (NYHA class III or IV).
Severe non-cardiovascular complications with an expected survival of less than 6months.
Unavailability for follow-up.
Presence of dementia, psychiatric disorders, or other known neurological conditionsthat complicate follow-up.
Current participation in another therapeutic study with ongoing treatment andfollow-up.
Other conditions that are not suitable for participation in this study as determinedby the investigator.
Study Design
Connect with a study center
The Third The People's Hospital Of Bengbu
Bengbu, Anhui 233000
ChinaSite Not Available
Xuanwu Hospital, Capital Medical University
Beijing, Beijing 100053
ChinaActive - Recruiting
The First Affiliated Hospital of Chongqing Medical and Pharmaceutical College
Chongqing, Chongqing 401121
ChinaActive - Recruiting
The First Affiliated Hospital Of Xiamen University
Xiamen, Fujian 361003
ChinaSite Not Available
The Second People's Hospital Of Qinzhou
Qinzhou, Guangxi 535099
ChinaSite Not Available
Wuzhou Red Cross Hospital
Wuzhou, Guangxi 543002
ChinaSite Not Available
The First Hospital Of Qiqihar
Qiqihar, Heilongjiang 161005
ChinaSite Not Available
Luoyang Yanshi People's Hospital
Luoyang, Henan 471900
ChinaActive - Recruiting
Xihua People's Hospital
Zhoukou, Henan 466000
ChinaSite Not Available
Liuyang Jili Hospital
Liuyang, Hunan 410300
ChinaActive - Recruiting
Xiangtan Central Hospital
Xiangtan, Hunan 411100
ChinaActive - Recruiting
Zhuzhou Central Hospital
Zhuzhou, Hunan 412007
ChinaSite Not Available
Affiliated Hospital of Inner Mongolia University for the Nationalities
Tongliao, Inner Mongolia 028007
ChinaActive - Recruiting
Ulanqab Central Hospital
Ulanqab, Inner Mongolia 012000
ChinaSite Not Available
Zha Lan Tun Shi Zhong Meng Yi Yuan
Zhalantun, Inner Mongolia 162650
ChinaActive - Recruiting
Jingdezhen NO.1 People's Hospital
Jingdezhen, Jiangxi 333000
ChinaActive - Recruiting
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi 330008
ChinaSite Not Available
Jinan Third People's Hospital
Jinan, Shandong 250101
ChinaSite Not Available
The Third People Hospital In Liaocheng
Liaocheng, Shandong 252000
ChinaActive - Recruiting
Weihai Municipal Hospital
Weihai, Shandong 264200
ChinaActive - Recruiting
The People's Hospital Of Leshan
Leshan, Sichuan 614000
ChinaSite Not Available
Shihezi City People's Hospital
Shihezi, Xinjiang 832000
ChinaSite Not Available
Haiyan People's Hospital
Jiaxing, Zhejiang 314311
ChinaActive - Recruiting
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