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Safety and Efficacy of Early Administration of Tirofiban in Patients Treated With Tenecteplase for Acute Ischemic Stroke

Status: Recruiting
Location: See all (38) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to assess the safety and efficacy of early administration of tirofiban in patients treated with tenecteplase for acute ischemic stroke.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years old;

• Within 4-24 hours after intravenous thrombolytic therapy with tenerplase for acute ischemic stroke, there was no significant change in symptoms compared to the baseline (defined as an increase or decrease of 0 or 1 point in the NIHSS score), and neurological function deteriorated (defined as an increase of ≥ 2 in the NIHSS score compared to the baseline) Fluctuations in neurological function (defined as an increase of 4 points or more in the NIHSS score compared to the baseline and then a decrease of 4 points or more);

• NIHSS ≥ 4 points before randomization;

• The patient or their family members sign a written informed consent form.

Locations
Other Locations
China
Zhongmeng Hospital of Hexigten Banner
RECRUITING
Chifeng
Mingguang People's Hospital
RECRUITING
Chuzhou
Dalian Municipal Central Hospital
RECRUITING
Dalian
Ganzhou Municipal Hospital
RECRUITING
Ganzhou
Ganzhou People's Hospital
RECRUITING
Ganzhou
Nankang TCM Hospital
RECRUITING
Ganzhou
People's Hospital of Anyuan County
RECRUITING
Ganzhou
People's Hospital of Chongyi County
RECRUITING
Ganzhou
People's Hospital of Dayu County
RECRUITING
Ganzhou
People's Hospital of Ganxian District
RECRUITING
Ganzhou
People's Hospital of Quannan County
RECRUITING
Ganzhou
People's Hospital of RuiJin City
RECRUITING
Ganzhou
People's Hospital of Shangyou County
RECRUITING
Ganzhou
People's Hospital of Shicheng County
RECRUITING
Ganzhou
People's Hospital of Xinfeng County
RECRUITING
Ganzhou
People's Hospital of Xunwu County
RECRUITING
Ganzhou
People's Hospital of Yudu County
RECRUITING
Ganzhou
Second Hospital of Xingguo County
RECRUITING
Ganzhou
Second People's Hospital of Yudu County
RECRUITING
Ganzhou
The People's Hospital of Ningdu County
RECRUITING
Ganzhou
Traditional Chinese Medicine Hospital of Xingguo County
RECRUITING
Ganzhou
Traditional Chinese Medicine Hospital of Yudu County
RECRUITING
Ganzhou
Hunan Xupu Chengnan Hospital
RECRUITING
Huaihua
Huangmei People's Hospital
RECRUITING
Huanggang
Ji'an Central People's Hospital
RECRUITING
Ji’an
People's Hospital of Wan'an county
RECRUITING
Ji’an
Affiliated Hospital of Jiujiang University
RECRUITING
Jiujiang
Longyan People´s Hospital, Longyan City
RECRUITING
Longyan
Jiangxi Provincial People's Hospital
RECRUITING
Nanchang
The Second Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
People's Hospital Of Shaodong
RECRUITING
Shaoyang
Songyuan Jilin Oilfield Hospital
RECRUITING
Songyuan
Shaoshan People's Hospital
RECRUITING
Xiangtan
Xiangtan Central Hospitall
RECRUITING
Xiangtan
Yiling People's Hospital of Yichang city
RECRUITING
Yichang
People's Hospital of Yichun
RECRUITING
Yichun
Yingtan People's Hospital
RECRUITING
Yingtan
Hunan University of Medicine Affiliated Pingjiang Hospital
RECRUITING
Yueyang
Contact Information
Primary
Deyan Kong, MD
kongdeyangxnn@163.com
+8618376635080
Backup
Guoyong Zeng, MD
hsyygy@163.com
+8613507079530
Time Frame
Start Date: 2024-04-24
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 348
Treatments
Experimental: Tirofiban
Patients are treated with intravenous tenecteplase first, and patients who meet the selection criteria will be randomly assigned to either the tirofiban or placebo group in a 1:1 ratio. Patients assigned to the tirofiban group will be treated with intravenous tirofiban. It is recommended to start treatment as soon as possible (within 10 minutes recommended) after randomization. Tirofiban will be administered at a dose of 0.3 μg per kilogram of body weight per minute for 30 minutes, followed by a continuous infusion of 0.075 μg per kilogram per minute for 47.5h. Aspirin placebo (1 tablet) and/or clopidogrel placebo (1 tablet) will be given orally at 24h after intravenous tenecteplase. Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 44h after randomization until the follow-up period of 90 days.
Placebo_comparator: Placebo
All patients are treated with intravenous tenecteplase first, and patients who meet the selection criteria will be randomly assigned to either the tirofiban or placebo group in a 1:1 ratio. Patients assigned to the placebo group will be treated with intravenous saline. It is recommended to start treatment as soon as possible (within 10 minutes recommended) after randomization. Placebo will be administered at a dose of 0.3 μg per kilogram of body weight per minute for 30 minutes, followed by a continuous infusion of 0.075 μg per kilogram per minute for 47.5h. Aspirin (1 tablet) and/or clopidogrel (1 tablet) will be given orally at 24h after intravenous tenecteplase. Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 44h after randomization until the follow-up period of 90 days.
Related Therapeutic Areas
Sponsors
Collaborators: Ganzhou City People's Hospital
Leads: Second Affiliated Hospital of Guangxi Medical University

This content was sourced from clinicaltrials.gov

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