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RECRUITING Phase 3 ClinicalTrials.gov

Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT)

Sponsor: Capital Medical University • ClinicalTrials.gov ID: NCT06548971

Registry updated: 2026-09-24
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Description

Stroke is the second leading cause of death worldwide, and ischemic stroke is the most frequent type. Intravenous thrombolysis with recombinant tissue plasminogen activator within 4.5 hours of symptom onset is the most effective therapy for patients with acute ischemic stroke. However, ischemic stroke progression and early reocclusion are not an uncommon phenomenon in patients after intravenous thrombolysis, resulting in neurological deterioration, which is associated with unfavorable functional outcomes. The underlying mechanism mainly involves the augmented platelet activation, triggered by the activated coagulation cascade during thrombolysis, which peaks within 2 hours of initiating rt-PA administration. Therefore, early antiplatelet therapy following intravenous thrombolysis represents a promising therapeutic approach to prevent neurological deterioration and improve the functional outcome of patients treated with intravenous thrombolysis. Currently, guidelines recommend initiating antiplatelet therapy 24 hours after intravenous thrombolysis due to the potential risk of increased bleeding. The safety and efficacy of early antiplatelet treatment following intravenous thrombolysis in patients with acute ischemic stroke remain clear. The study aims to test the hypothesis that in patients with acute ischemic stroke treated with intravenous thrombolysis, early administration of oral aspirin will improve functional outcomes without increasing the risk of intracranial hemorrhage.

Interventions

  • Aspirin (Drug)
    Patients in the interventional group will chew 300mg of aspirin enteric-coated tablets as soon as possible after randomization. If swallowing difficulties arise, the tablets can be crushed and administered via a nasogastric tube.
  • Placebo (Drug)
    Patients in the control group will chew 300mg of placebos as soon as possible after randomization. If swallowing difficulties arise, the placebo can be crushed and administered via a nasogastric tube.
  • Best medical management (Other)
    Patients in both groups will receive the best medical management according to the guidelines.

Eligibility criteria

Inclusion Criteria: 1. Age ≥18 years old; 2. Acute ischemic stroke treated with intravenous thrombolysis with alteplase or tenecteplase within 4.5 hours of onset or time last known well, and can receive the study drug treatment within 3 hours of initiating intravenous thrombolysis. 3. Residual NIHSS score \> 5 points assessed 1 hour after initiation of intravenous thrombolysis and prior to randomization. 4. Informed consent obtained from patients or an authorized representative. Exclusion Criteria: 1. Stroke caused by definite large vessel occlusion (including A1/A2 segments of the anterior cerebral artery, M1/M2 segments of the middle cerebral artery, P1/P2 segments of the posterior cerebral artery, intracranial/extracranial segments of the internal carotid artery, basilar artery, and bilateral vertebral artery occlusion) confirmed by vessel imaging (including computed tomography angiography \[CTA\] or magnetic resonance angiography \[MRA\]), or scheduled for endovascular treatment (including mechanical thrombectomy, intra-arterial thrombolysis, and angioplasty). 2. Intracranial hemorrhage confirmed by imaging post-thrombolysis. 3. Definite or suspected cardioembolic stroke. 4. Stroke caused by other determined causes, including nonatherosclerotic vasculopathies (moyamoya disease, artery dissection, arteritis), hypercoagulable states, or hematological disorders. 5. Use of antiplatelet therapy within one week prior to stroke onset, novel anticoagulant drugs within 48 hours prior to stroke onset, or treatment with warfarin with an international normalized ratio (INR)\>1.7. 6. Prior history of moderate or severe ischemic stroke events with residual neurological disability. 7. Pre-stroke mRS score \> 1. 8. Severe consciousness disturbance with NIHSS item 1a (level of consciousness) ≥ 2 points. 9. Post-thrombolysis imaging indicates an infarct area larger than 1/2 responsible artery supply area. 10. Known contraindications for antiplatelet therapy, such as coagulation disorders, or systemic bleeding 11. History of aspirin allergy. 12. Anticipated indications for anticoagulant therapy during the study period (e.g., atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism, antiphospholipid syndrome, hypercoagulable state) 13. Presence of malignant tumors, chronic hemodialysis, severe renal insufficiency (GFR \< 30 mL/min or serum creatinine \> 220 μmol/L \[2.5 mg/dL\]), severe hepatic insufficiency (serum alanine aminotransferase \[ALT\] \>2 times the upper limit of normal, or serum aspartate aminotransferase \[AST\] \>2 times the upper limit of normal), severe heart failure (New York Heart Association \[NYHA\] Functional Classification Class III or IV) 14. Severe non-cardiovascular complications with an expected survival of less than 6 months. 15. Unavailability for follow-up. 16. Presence of dementia, psychiatric disorders, or other known neurological conditions that complicate follow-up. 17. Current participation in another therapeutic study with ongoing treatment and follow-up. 18. Other conditions that make the patient unsuitable for participation in the study as determined by the investigator.

Conditions

Acute Ischemic Stroke Cerebral Infarction

Locations

  • The Third The People's Hospital Of Bengbu — Bengbu, Anhui, China
  • Huaiyuan county traditional Chinese medicine hospital — Bengbu, Anhui, China
  • Bozhou people's hospital — Bozhou, Anhui, China
  • Huaibei people's hospital — Huaibei, Anhui, China
  • Suzhou municipal hospital — Suzhou, Anhui, China
  • Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China
  • Aerospace central hospital — Haidian, Beijing Municipality, China
  • Beijing Pinggu District Hospital — Pinggu, Beijing Municipality, China
  • Beijing Luhe Hospital affiliated to Capital Medical University — Tongzhou, Beijing Municipality, China
  • Fujian university affiliated provincial hospital — Fuzhou, Fujian, China
  • The First Affiliated Hospital Of Xiamen University — Xiamen, Fujian, China
  • Xiamen Xinglin hospital — Xiamen, Fujian, China
  • Zhangzhou Hospital of Fujian Province — Zhangzhou, Fujian, China
  • Heyuan people's hospital — Heyuan, Gangdong, China
  • Brain Hospital Affiliated to Guangzhou Medical University — Guangzhou, Guangdong, China
  • People's Hospital of Longchuan County — Heyuan, Guangdong, China
  • Guigang people's hospitalv — Guigang, Guangxi, China
  • Wuzhou Red Cross Hospital — Wuzhou, Guangxi, China
  • The Second Affiliated Hospital of Guizhou Medical University — Kaili, Guizhou, China
  • The Second Affiliated Hospital of Hainan Medical University — Haikou, Hainan, China
  • Cangzhou combination of Chinese traditional and western medicine hospital — Cangzhou, Hebei, China
  • Cangzhou Central Hospital — Cangzhou, Hebei, China
  • Botou traditional Chinese medicine hospital — Cangzhou, Hebei, China
  • Xian county People's Hospital — Cangzhou, Hebei, China
  • Hejian city People's Hospital — Cangzhou, Hebei, China
  • Handan Central Hospital — Handan, Hebei, China
  • Handan first hospital — Handan, Hebei, China
  • Ci county people's hospital — Handan, Hebei, China
  • Handan Yongnian District First Hospital — Handan, Hebei, China
  • Yutian county Hospital — Tangshan, Hebei, China
  • Qinghe county people's hospital — Xingtai, Hebei, China
  • Xingtai ninth hospital — Xingtai, Hebei, China
  • Harbin 242 hospital — Haerbin, Heilongjiang, China
  • Jiamusi university hongda hospital — Jiamusi, Heilongjiang, China
  • Mudanjiang first people's hospital — Mudanjiang, Heilongjiang, China
  • The First Hospital Of Qiqihar — Qiqihar, Heilongjiang, China
  • Hua county People's Hospital — Anyang, Henan, China
  • Jun county people's hospital — Hebi, Henan, China
  • Jiaozuo Second People's Hospital — Jiangzuo, Henan, China
  • Kaifeng central hospital — Kaifeng, Henan, China
  • First People's Hospital of Luoyang — Luoyang, Henan, China
  • Luoyang yiluo hospital — Luoyang, Henan, China
  • Mengjin county people's hospital — Luoyang, Henan, China
  • Luoyang Yanshi People's Hospital — Luoyang, Henan, China
  • Nanyang Central Hospital — Nanyang, Henan, China
  • Nanyang nanshi hospital — Nanyang, Henan, China
  • Nanle county people's hospital — Puyang, Henan, China
  • Huanghe Sanmenxia hospital — Sanmenxia, Henan, China
  • Shangqiu Third People's Hospital — Shangqiu, Henan, China
  • Sui county traditional Chinese medicine hospital — Shangqiu, Henan, China
  • Shangqiu First People's Hospital — Shangqiu, Henan, China
  • Sui county people's hospital — Shangqiu, Henan, China
  • Ningling county people's hospital — Shangqucun, Henan, China
  • Xixian county people's hospital — Xinyang, Henan, China
  • Xihua People's Hospital — Zhoukou, Henan, China
  • Shenqiu county People's Hospital — Zhoukou, Henan, China
  • Luyi county people's hospital — Zhoukou, Henan, China
  • Zhumadian Central Hospital — Zhumadian, Henan, China
  • The Third People's Hospital of Hubei Province — Hainan, Hubei, China
  • Jingmen people's hospital — Jingmen, Hubei, China
  • Xiangyang central hospital — Xiangyang, Hubei, China
  • The First People's Hospital of Changde City — Changde, Hunan, China
  • Li county people's hospital — Changde, Hunan, China
  • Xiangya Hospital Centralsouth University — Changsha, Hunan, China
  • Chenzhou first people's hospital — Chenzhou, Hunan, China
  • Liuyang Jili Hospital — Guankou, Hunan, China
  • Lengshuijiang People's Hospital — Loudi, Hunan, China
  • Shaodong county people's hospital — Shanyang, Hunan, China
  • Xiangtan Central Hospital — Xiangtan, Hunan, China
  • Xiangxiang people's hospital — Xiangxiang, Hunan, China
  • Ningyuan county People's Hospital — Yongzhou, Hunan, China
  • Zhuzhou Central Hospital — Zhuzhou, Hunan, China
  • Affiliated Hospital of Inner Mongolia University for the Nationalities — Tongliao, Inner Mongolia, China
  • Ulanqab Central Hospital — Ulanqab, Inner Mongolia, China
  • Zha Lan Tun Shi Zhong Meng Yi Yuan — Zhalantun, Inner Mongolia, China
  • Donghai county people's hospital — Lianyungang, Jiangsu, China
  • The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China
  • The Fourth Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China
  • Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China
  • Xuzhou Xin health hospital — Xuzhou, Jiangsu, China
  • Jiawang district People's Hospital — Xuzhou, Jiangsu, China
  • Fengxian county people's hospital — Xuzhou, Jiangsu, China
  • Jingdezhen NO.1 People's Hospital — Jingdezhen, Jiangxi, China
  • The Second Affiliated Hospital Of Nanchang University — Nanchang, Jiangxi, China
  • Anshan Changda hospital — Anshan, Liaoning, China
  • Lvshunkou district traditional Chinese medicine hospital — Dalian, Liaoning, China
  • Donggang city Central Hospital — Dandong, Liaoning, China
  • Fushun Mining Bureau General Hospital — Fushun, Liaoning, China
  • Fuxin people's hospital — Fuxin, Liaoning, China
  • Kezuo Zhongqi People's Hospital — Tongliao, Neimenggu, China
  • Togtoh county hospital — Neimeng, Neimeng, China
  • Tuquan county people's hospital — Xingan, Neimeng, China
  • Ningjin county people's hospital — Dezhou, Shandong, China
  • Dongying people's hospital — Dongying, Shandong, China
  • Shengli oilfield central hospital — Dongying, Shandong, China
  • Shandong province qianfoshan hospital — Jinan, Shandong, China
  • Jinan Third People's Hospital — Jinan, Shandong, China
  • Jiaxiang county people's hospital — Jining, Shandong, China
  • Liaocheng people's hospital — Liaocheng, Shandong, China
  • The Third People Hospital In Liaocheng — Liaocheng, Shandong, China
  • Gaotang county people's hospital — Liaocheng, Shandong, China
  • Pingdu city traditional Chinese medicine hospital — Qingdao, Shandong, China
  • Juxian county people's hospital — Rizhao, Shandong, China
  • Rizhao traditional Chinese medicine hospital — Rizhao, Shandong, China
  • Shandong health group feicheng hospital — Taian, Shandong, China
  • Weifang people's hospital — Weifang, Shandong, China
  • Weihai Municipal Hospital — Weihai, Shandong, China
  • Weihai Central Hospital — Weihai, Shandong, China
  • Zibo Central Hospital — Zibo, Shandong, China
  • Baoji Fengxiang district hospital — Baoji, Shanxi, China
  • Datong third people's hospital — Datong, Shanxi, China
  • Linfen people's hospital — Linfen, Shanxi, China
  • Shenzhen Second People's Hospital — Shenzhen, Shenzhen, China
  • Chengdu Second People's Hospital — Chengdu, Sichuan, China
  • Ya 'an People's Hospital — Ya'an, Sichuan, China
  • Tianjin Xiqing hospital — Tianjin, Tianjin Municipality, China
  • Shihezi City People's Hospital — Shihezi, Xinjiang, China
  • Wenshan Zhou people's hospital — Wenshan, Yunnan, China
  • Haiyan People's Hospital — Jiaxing, Zhejiang, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record