Back to resultsTirofiban for the Prevention of Neurological Deterioration in Acute Ischemic Stroke (TREND)
Primary Purpose
Acute Stroke
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tirofiban Hydrochloride
Oral antiplatelet
Sponsored by
About this trial
This is an interventional treatment trial for Acute Stroke focused on measuring Acute ischemic stroke, Neurological deterioration, Stroke progression
Eligibility Criteria
Inclusion Criteria:
- Acute ischemic stroke with 24 hours of symptom onset.
- NIHSS≥4 and ≤20 points, and the paralyzed limbs is able to actively move the muscle (standardized motor examination rating scale of 2 or much higher).
- Age 18-80 years old.
- Informed consent obtained from patient or acceptable patient's surrogate.
Exclusion Criteria:
- Treated with intravenous or endovascular thrombectomy for the indexed acute ischemic stroke.
- Acute ischemic stroke caused by determined or suspected cardioembolism.
- Acute ischemic stroke caused by other determined caused, including moyamoya disease, artery dissection, arteritis, and etc.
- Pre-stroke mRS ≥2 or the paralyzed limbs are dyskinesia before stroke.
- Known hematochezia, gastrointestinal bleeding and any other bleeding.
- Allergy to tirofiban or its solvents.
- Patients suffered from severe diseases, including malignant tumor, liver cirrhosis, kidney failure, congestive heart failure, and etc.
- Gastrointestinal or genitourinary tract bleeding within 1 years.
- Determined coagulation disorders, platelet dysfunction, or platelet count <100*109/L.
- Major surgical operation or severe trauma within 1 month.
- Hemorrhagic retinopathy.
- Chronic hemodialysis.
- Uncontrolled hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg.
- Acute pericarditis.
- Other conditions that determined by the investigators.
Sites / Locations
- Xuanwu Hospital, Capital Medical UniversityRecruiting
- Beijing Luhe Hospital, Capital Medical University
- The first Affiliated Hospital of Henan University of Science and Technology
- Nanyang Central HospitalRecruiting
- Nanyang Second General HospitalRecruiting
- First Affiliated Hospital of Zhengzhou University
- Henan Provincial People's Hospital
- The Third People's Hospital of Hubei Province
- Hunan Provincial People's Hospital
- Sinapharm North HospitalRecruiting
- Ordos Central HospitalRecruiting
- Tongliao City HosptialRecruiting
- Nanjing Drum Tower Hospital
- Jiangxi Provincial People's Hospital
- Shandong Provincial Hospital
- Shandong Provincial Qianfoshan Hospital
- West China Hospital of Sichuan University
- Beichen Hospital of Traditional Chinese MedicineRecruiting
- TEDA Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tirofiban+Oral antiplatelet therapy
Oral antiplatelet therapy
Arm Description
Patients will receive Tirofiban in the first 72 hours and bridge to oral antiplatelet therapy thereafter.
Patients will receive oral antiplatelet therapy alone.
Outcomes
Primary Outcome Measures
Number of patients with a change in NIHSS by ≥ 4 points compared to enrollment NIHSS.
National Health Institute Stroke Scale (NIHSS): stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms.
Secondary Outcome Measures
Change of the NIHSS
National Health Institute Stroke Scale (NIHSS): stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms.
Change of the Scandinavian Stroke Scale
Scandinavian Stroke Scale (SSS): stroke symptom severity scale with a range of 0-58. Lower score means more severe stroke symptoms.
The severity of global disability at 90 days, as assessed by modified Rankin scale (mRS).
The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death).
Rate of symptomatic intracerebral hemorrhage.
Number of Participants experienced adverse events
Full Information
NCT ID
NCT04491695
First Posted
July 25, 2020
Last Updated
July 16, 2022
Sponsor
Capital Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04491695
Brief Title
Tirofiban for the Prevention of Neurological Deterioration in Acute Ischemic Stroke
Acronym
TREND
Official Title
Safety and Efficacy of Tirofiban in Preventing Neurological Deterioration of Patients With Acute Ischemic Stroke: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Currently, dual antiplatelet therapy with aspirin and clopidogrel (with loading doses) is widely used for patients with acute ischemic stroke. However, immediate, potent and reversible inhibition of platelet aggregation is not possible. Additionally, more than 5% patients have aspirin resistance and more than 15% patients have clopidogrel resistance. Therefore, an intravenously administered GPIIb/IIIa receptor inhibitor (Tirofiban) receptor blocker with fast onset and offset of actions will provide more desired antiplatelet effects in the setting of acute ischemic stroke, especially in patients with high risk of neurological deterioration. This study will measure the anti-platelet effects of Tirofiban in patients with acute ischemic stroke who had high risk of neurological deterioration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke
Keywords
Acute ischemic stroke, Neurological deterioration, Stroke progression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
420 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tirofiban+Oral antiplatelet therapy
Arm Type
Experimental
Arm Description
Patients will receive Tirofiban in the first 72 hours and bridge to oral antiplatelet therapy thereafter.
Arm Title
Oral antiplatelet therapy
Arm Type
Active Comparator
Arm Description
Patients will receive oral antiplatelet therapy alone.
Intervention Type
Drug
Intervention Name(s)
Tirofiban Hydrochloride
Intervention Description
Tirofiban will use a loading dose, 0.4 μg/kg/min × 30 minutes, then 0.1μg/kg/min infusion for 71.5 hours.
Intervention Type
Drug
Intervention Name(s)
Oral antiplatelet
Intervention Description
Aspirin, clopidogrel or other antiplatelet drugs. Loading dose will be considered if the patients is not on antiplatelet therapy.
Primary Outcome Measure Information:
Title
Number of patients with a change in NIHSS by ≥ 4 points compared to enrollment NIHSS.
Description
National Health Institute Stroke Scale (NIHSS): stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms.
Time Frame
Within 72 hours of intervention.
Secondary Outcome Measure Information:
Title
Change of the NIHSS
Description
National Health Institute Stroke Scale (NIHSS): stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms.
Time Frame
0-30 days of intervention.
Title
Change of the Scandinavian Stroke Scale
Description
Scandinavian Stroke Scale (SSS): stroke symptom severity scale with a range of 0-58. Lower score means more severe stroke symptoms.
Time Frame
0-30 days of intervention.
Title
The severity of global disability at 90 days, as assessed by modified Rankin scale (mRS).
Description
The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death).
Time Frame
0-90 days.
Title
Rate of symptomatic intracerebral hemorrhage.
Time Frame
0-90 days
Title
Number of Participants experienced adverse events
Time Frame
0-90 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute ischemic stroke with 24 hours of symptom onset.
NIHSS≥4 and ≤20 points, and the paralyzed limbs is able to actively move the muscle (standardized motor examination rating scale of 2 or much higher).
Age 18-80 years old.
Informed consent obtained from patient or acceptable patient's surrogate.
Exclusion Criteria:
Treated with intravenous or endovascular thrombectomy for the indexed acute ischemic stroke.
Acute ischemic stroke caused by determined or suspected cardioembolism.
Acute ischemic stroke caused by other determined caused, including moyamoya disease, artery dissection, arteritis, and etc.
Pre-stroke mRS ≥2 or the paralyzed limbs are dyskinesia before stroke.
Known hematochezia, gastrointestinal bleeding and any other bleeding.
Allergy to tirofiban or its solvents.
Patients suffered from severe diseases, including malignant tumor, liver cirrhosis, kidney failure, congestive heart failure, and etc.
Gastrointestinal or genitourinary tract bleeding within 1 years.
Determined coagulation disorders, platelet dysfunction, or platelet count <100*109/L.
Major surgical operation or severe trauma within 1 month.
Hemorrhagic retinopathy.
Chronic hemodialysis.
Uncontrolled hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg.
Acute pericarditis.
Other conditions that determined by the investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingfeng Ma, M.D.
Phone
010-83199430
Email
m.qingfeng@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wenbo Zhao, M.D.
Phone
86-13120136877
Email
zhaowb.cool@163.com
Facility Information:
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingfeng Ma, M.D.
First Name & Middle Initial & Last Name & Degree
Wenbo Zhao, M.D.
First Name & Middle Initial & Last Name & Degree
Qingfeng Ma
Facility Name
Beijing Luhe Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huishan Du, M.D.
First Name & Middle Initial & Last Name & Degree
Xiaokun Geng, M.D.
Facility Name
The first Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junqiang Yan, M.D.
Facility Name
Nanyang Central Hospital
City
Nanyang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changming Wen, M.D.
Facility Name
Nanyang Second General Hospital
City
Nanyang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinhui Qin, M.D.
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuming Xu
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziliang Wang, M.D.
Facility Name
The Third People's Hospital of Hubei Province
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Hunan Provincial People's Hospital
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoping Gao, M.D.
Facility Name
Sinapharm North Hospital
City
Baotou
State/Province
Inner Mongolia Autonomous Region
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lifei Xing, M.D.
Facility Name
Ordos Central Hospital
City
Ordos
State/Province
Inner Mongolia Autonomous Region
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojun Hao
Facility Name
Tongliao City Hosptial
City
Tongliao
State/Province
Inner Mongolia Autonomous Region
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaoming Xu, M.D.
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Xu, M.D.
Facility Name
Jiangxi Provincial People's Hospital
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinjian Sun, M.D.
Facility Name
Shandong Provincial Qianfoshan Hospital
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Wu, M.D.
Facility Name
Beichen Hospital of Traditional Chinese Medicine
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruixian Wang, M.D.
Facility Name
TEDA Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
31570084
Citation
Wu C, Sun C, Wang L, Lian Y, Xie N, Huang S, Zhao W, Ren M, Wu D, Ding J, Song H, Wang Y, Ma Q, Ji X. Low-Dose Tirofiban Treatment Improves Neurological Deterioration Outcome After Intravenous Thrombolysis. Stroke. 2019 Dec;50(12):3481-3487. doi: 10.1161/STROKEAHA.119.026240. Epub 2019 Oct 1.
Results Reference
background
PubMed Identifier
29127270
Citation
Zhao W, Che R, Shang S, Wu C, Li C, Wu L, Chen J, Duan J, Song H, Zhang H, Ling F, Wang Y, Liebeskind D, Feng W, Ji X. Low-Dose Tirofiban Improves Functional Outcome in Acute Ischemic Stroke Patients Treated With Endovascular Thrombectomy. Stroke. 2017 Dec;48(12):3289-3294. doi: 10.1161/STROKEAHA.117.019193. Epub 2017 Nov 10.
Results Reference
result
Learn more about this trial
Tirofiban for the Prevention of Neurological Deterioration in Acute Ischemic Stroke
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