Safety and Efficacy of Treatment with Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT): a Multicenter, Randomized, Placebo-controlled, Clinical Trial
Status: Recruiting
Location: See all (23) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years old;
• 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.
• NIHSS score improvement ≤ 2 points or worsening ≤ 4 points one hour after initiating intravenous thrombolysis compared to pre-thrombolysis.
• Residual NIHSS score \> 5 points at randomization.
• Informed consent obtained from patients or their acceptable surrogates.
Locations
Other Locations
China
Xuanwu Hospital, Capital Medical University
RECRUITING
Beijing
The Third The People's Hospital Of Bengbu
NOT_YET_RECRUITING
Bengbu
The First Affiliated Hospital of Chongqing Medical and Pharmaceutical College
RECRUITING
Chongqing
Liuyang Jili Hospital
RECRUITING
Guankou
Haiyan People's Hospital
RECRUITING
Jiaxing
Jinan Third People's Hospital
NOT_YET_RECRUITING
Jinan
Jingdezhen NO.1 People's Hospital
RECRUITING
Jingdezhen
The People's Hospital Of Leshan
NOT_YET_RECRUITING
Leshan
The Third People Hospital In Liaocheng
RECRUITING
Liaocheng
Luoyang Yanshi People's Hospital
RECRUITING
Luoyang
The Second Affiliated Hospital Of Nanchang University
NOT_YET_RECRUITING
Nanchang
The Second People's Hospital Of Qinzhou
NOT_YET_RECRUITING
Qinzhou
The First Hospital Of Qiqihar
NOT_YET_RECRUITING
Qiqihar
Shihezi City People's Hospital
NOT_YET_RECRUITING
Shihezi
Affiliated Hospital of Inner Mongolia University for the Nationalities
RECRUITING
Tongliao
Ulanqab Central Hospital
NOT_YET_RECRUITING
Ulanqab
Weihai Municipal Hospital
RECRUITING
Weihai
Wuzhou Red Cross Hospital
NOT_YET_RECRUITING
Wuzhou
The First Affiliated Hospital Of Xiamen University
NOT_YET_RECRUITING
Xiamen
Xiangtan Central Hospital
RECRUITING
Xiangtan
Zha Lan Tun Shi Zhong Meng Yi Yuan
RECRUITING
Zhalantun
Xihua People's Hospital
NOT_YET_RECRUITING
Zhoukou
Zhuzhou Central Hospital
NOT_YET_RECRUITING
Zhuzhou
Contact Information
Primary
XunMing Ji, MD, PD
jixm@ccmu.edu.cn
010-8319-9439
Backup
Wenbo Zhao, MD, PD
zhaowb@xwh.ccmu.edu.cn
010-8319-9048
Time Frame
Start Date:2024-11-07
Estimated Completion Date:2026-03
Participants
Target number of participants:1184
Treatments
Experimental: Interventional group
Patients in the interventional group will receive early antiplatelet treatment with oral aspirin within 3 hours of initiating intravenous thrombolysis. In addition, the best medical management will be administered according to the guidelines.
Placebo_comparator: Control group
Patients in the control group will receive placebos within 3 hours of initiating intravenous thrombolysis. In addition, the best medical management will be administered according to the guidelines.