Tirofiban for the Prevention of Neurological Deterioration in Acute Ischemic Stroke

Acute Stroke Clinical Trial

— TREND  

Official title:

Safety and Efficacy of Tirofiban in Preventing Neurological Deterioration of Patients With Acute Ischemic Stroke: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04491695
• Other study ID #: TREND
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 12, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: July 2022
• Source: Capital Medical University
• Contact: Qingfeng Ma, M.D.
• Phone: 010-83199430
• Email: m.qingfeng[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Acute ischemic stroke with 24 hours of symptom onset.

2. 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).

3. Age 18-80 years old.

4. Informed consent obtained from patient or acceptable patient's surrogate.

Exclusion Criteria:

1. Treated with intravenous or endovascular thrombectomy for the indexed acute ischemic stroke.

2. Acute ischemic stroke caused by determined or suspected cardioembolism.

3. Acute ischemic stroke caused by other determined caused, including moyamoya disease, artery dissection, arteritis, and etc.

4. Pre-stroke mRS =2 or the paralyzed limbs are dyskinesia before stroke.

5. Known hematochezia, gastrointestinal bleeding and any other bleeding.

6. Allergy to tirofiban or its solvents.

7. Patients suffered from severe diseases, including malignant tumor, liver cirrhosis, kidney failure, congestive heart failure, and etc.

8. Gastrointestinal or genitourinary tract bleeding within 1 years.

9. Determined coagulation disorders, platelet dysfunction, or platelet count <100*109/L.

10. Major surgical operation or severe trauma within 1 month.

11. Hemorrhagic retinopathy.

12. Chronic hemodialysis.

13. Uncontrolled hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg.

14. Acute pericarditis.

15. Other conditions that determined by the investigators.

Related Conditions & MeSH terms

• Acute Stroke
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Tirofiban Hydrochloride
Tirofiban will use a loading dose, 0.4 µg/kg/min × 30 minutes, then 0.1µg/kg/min infusion for 71.5 hours.
• Oral antiplatelet
Aspirin, clopidogrel or other antiplatelet drugs. Loading dose will be considered if the patients is not on antiplatelet therapy.

Locations

Country	Name	City	State
China	Sinapharm North Hospital	Baotou	Inner Mongolia Autonomous Region
China	Beijing Luhe Hospital, Capital Medical University	Beijing	Beijing
China	Xuanwu Hospital, Capital Medical University	Beijing	Beijing
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Shandong Provincial Hospital	Jinan	Shandong
China	Shandong Provincial Qianfoshan Hospital	Jinan	Shandong
China	The first Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Nanyang Central Hospital	Nanyang	Henan
China	Nanyang Second General Hospital	Nanyang	Henan
China	Ordos Central Hospital	Ordos	Inner Mongolia Autonomous Region
China	Beichen Hospital of Traditional Chinese Medicine	Tianjin	Tianjin
China	TEDA Hospital	Tianjin	Tianjin
China	Tongliao City Hosptial	Tongliao	Inner Mongolia Autonomous Region
China	The Third People's Hospital of Hubei Province	Wuhan	Hubei
China	First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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 De — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 72 hours of intervention.
Secondary	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.	0-30 days of intervention.
Secondary	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.	0-30 days of intervention.
Secondary	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).	0-90 days.
Secondary	Rate of symptomatic intracerebral hemorrhage.		0-90 days
Secondary	Number of Participants experienced adverse events		0-90 days.