Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT)
NCT Number: NCT06548971
Acronym: TREND-IVT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Acute Ischemic Stroke|Cerebral Infarction
Interventions: DRUG: Aspirin|DRUG: Placebo|OTHER: Best medical management
Sponsor: Capital Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1184
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-03
Locations: The Third The People's Hospital Of Bengbu, Bengbu, Anhui, 233000, China|Xuanwu Hospital, Capital Medical University, Beijing, Beijing, 100053, China|The First Affiliated Hospital of Chongqing Medical and Pharmaceutical College, Chongqing, Chongqing, 401121, China|The First Affiliated Hospital Of Xiamen University, Xiamen, Fujian, 361003, China|The Second People's Hospital Of Qinzhou, Qinzhou, Guangxi, 535099, China|Wuzhou Red Cross Hospital, Wuzhou, Guangxi, 543002, China|The First Hospital Of Qiqihar, Qiqihar, Heilongjiang, 161005, China|Luoyang Yanshi People's Hospital, Luoyang, Henan, 471900, China|Xihua People's Hospital, Zhoukou, Henan, 466000, China|Liuyang Jili Hospital, Liuyang, Hunan, 410300, China|Xiangtan Central Hospital, Xiangtan, Hunan, 411100, China|Zhuzhou Central Hospital, Zhuzhou, Hunan, 412007, China|Affiliated Hospital of Inner Mongolia University for the Nationalities, Tongliao, Inner Mongolia, 028007, China|Ulanqab Central Hospital, Ulanqab, Inner Mongolia, 012000, China|Zha Lan Tun Shi Zhong Meng Yi Yuan, Zhalantun, Inner Mongolia, 162650, China|Jingdezhen NO.1 People's Hospital, Jingdezhen, Jiangxi, 333000, China|The Second Affiliated Hospital Of Nanchang University, Nanchang, Jiangxi, 330008, China|Jinan Third People's Hospital, Jinan, Shandong, 250101, China|The Third People Hospital In Liaocheng, Liaocheng, Shandong, 252000, China|Weihai Municipal Hospital, Weihai, Shandong, 264200, China|The People's Hospital Of Leshan, Leshan, Sichuan, 614000, China|Shihezi City People's Hospital, Shihezi, Xinjiang, 832000, China|Haiyan People's Hospital, Jiaxing, Zhejiang, 314311, China

Summary:
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.

Primary Outcome Measures: The proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 90-day follow up., The mRS ranges from 0 to 6, with higher scores indicating a worse outcome. The primary outcome measure is based on the mRS score, which is dichotomized to define the excellent functional outcome as mRS score of 0-1 at 90-days follow up., Ninety days after stroke.
Secondary Outcome Measures: The proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 30-day follow up., The mRS ranges from 0 to 6, with higher scores indicating a worse outcome. The primary outcome measure is based on the mRS score, which is dichotomized to define the excellent functional outcome as mRS score of 0-1 at 30-days follow up., Thirty days after stroke.|The proportion of patients with a modified Rankin scale (mRS) score of 0-2 at 90-day follow up., The mRS ranges from 0 to 6, with higher scores indicating a worse outcome. Functional independence is defined as mRS of 0-2., Ninety days after stroke.|The shift analysis in the 90-day modified Rankin scale (mRS) score., The mRS ranges from 0 to 6, with higher scores indicating a worse outcome., Ninety days after stroke.|The proportion of patients achieving neurological improvement., Neurological improvement is defined as a decrease of ≥2 points in the NIHSS score at 48 hours of randomization compared to baseline assessment., Within 48 hours after stroke.|The proportion of patients experiencing early neurological deterioration., Early neurological deterioration is defined as an increase of ≥4 points in the NIHSS score within 24 hours of randomization compared with the minimum NIHSS score before deterioration., Within 24 hours after stroke.|The changes in the NIHSS score at 24 hours, 48 hours, and 7 days of enrollment as compared with the baseline., The NIHSS ranges from 0 to 42 points, with higher scores indicating worse neurological deficits., Within 7 days after stroke.
Other Outcome Measures: Incidence of symptomatic intracranial hemorrhage., Symptomatic intracranial hemorrhage is defined as the demonstration of hemorrhage within brain parenchyma on head imaging leading to an increase of at least 4 points in the NIHSS score, according to the criteria of the European Cooperative Acute Stroke Study III (ECASS III)., Within 48 hours after stroke.|Incidence of any intracranial hemorrhage., Any intracranial hemorrhage is defined as the demonstration of hemorrhage within brain parenchyma on head imaging, according to the criteria of the ECASS III., Within 48 hours after stroke.|Incidence of systemic hemorrhage., The incidence of systemic hemorrhage at any time from randomization through day 90, according to the criteria of the GUSTO., Within 90 days after stroke.|Incidence of recurrent stroke or other vascular events., The incidence of recurrent stroke or other vascular events (including hemorrhagic and ischemic stroke, myocardial infarction, and cardiovascular death) within 90 days of randomization., Within 90 days after stroke.|All-cause death., The incidence of death events at any time from randomization through day 90., Within 90 days after stroke.|Incidence of Adverse Events/Serious Adverse Events, The incidence of other adverse events and serious adverse events at any time from randomization through day 90., Within 90 days after stroke.