Tirofiban for the Prevention of Neurological Deterioration in Acute Ischemic Stroke

Phase 2

• Conditions: Acute Stroke
• Interventions: Drug: Tirofiban Hydrochloride; Drug: Oral antiplatelet

• Registration Number: NCT04491695
• Lead Sponsor: Capital Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-25
• Study First Submitted QC: 2020-07-25
• Study First Posted: 2020-07-29
• Study Start: 2020-09-12
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-16
• Last Update Posted: 2022-07-19
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 420

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tirofiban+Oral antiplatelet therapy	Tirofiban Hydrochloride	Patients will receive Tirofiban in the first 72 hours and bridge to oral antiplatelet therapy thereafter.
Tirofiban+Oral antiplatelet therapy	Oral antiplatelet	Patients will receive Tirofiban in the first 72 hours and bridge to oral antiplatelet therapy thereafter.
Oral antiplatelet therapy	Oral antiplatelet	Patients will receive oral antiplatelet therapy alone.

Primary Outcome Measures

Name	Time	Method
Number of patients with a change in NIHSS by ≥ 4 points compared to enrollment NIHSS.	Within 72 hours of intervention.	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

Name	Time	Method
Change of the NIHSS	0-30 days of intervention.	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	0-30 days of intervention.	Scandinavian Stroke Scale (SSS): stroke symptom severity scale with a range of 0-58. Lower score means more severe stroke symptoms.
Rate of symptomatic intracerebral hemorrhage.	0-90 days
Number of Participants experienced adverse events	0-90 days.
The severity of global disability at 90 days, as assessed by modified Rankin scale (mRS).	0-90 days.	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).

Trial Locations

Locations (19)

Beijing Luhe Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China

First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China

Shandong Provincial Qianfoshan Hospital; 🇨🇳 Jinan, Shandong, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Hunan Provincial People's Hospital; 🇨🇳 Changsha, Hunan, China

Sinapharm North Hospital; 🇨🇳 Baotou, Inner Mongolia Autonomous Region, China

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

The first Affiliated Hospital of Henan University of Science and Technology; 🇨🇳 Luoyang, Henan, China

Nanyang Central Hospital; 🇨🇳 Nanyang, Henan, China

Nanyang Second General Hospital; 🇨🇳 Nanyang, Henan, China

The Third People's Hospital of Hubei Province; 🇨🇳 Wuhan, Hubei, China

Tongliao City Hosptial; 🇨🇳 Tongliao, Inner Mongolia Autonomous Region, China

Ordos Central Hospital; 🇨🇳 Ordos, Inner Mongolia Autonomous Region, China

Jiangxi Provincial People's Hospital; 🇨🇳 Nanchang, Jiangxi, China

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China

Beichen Hospital of Traditional Chinese Medicine; 🇨🇳 Tianjin, Tianjin, China

TEDA Hospital; 🇨🇳 Tianjin, Tianjin, China