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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
420
Tirofiban will use a loading dose, 0.4 μg/kg/min × 30 minutes, then 0.1μg/kg/min infusion for 71.5 hours.
Aspirin, clopidogrel or other antiplatelet drugs. Loading dose will be considered if the patients is not on antiplatelet therapy.
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGBeijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGThe first Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
NOT_YET_RECRUITINGNanyang Central Hospital
Nanyang, Henan, China
RECRUITINGNanyang Second General Hospital
Nanyang, Henan, China
RECRUITINGFirst Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
NOT_YET_RECRUITINGHenan Provincial People's Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGThe Third People's Hospital of Hubei Province
Wuhan, Hubei, China
ACTIVE_NOT_RECRUITINGHunan Provincial People's Hospital
Changsha, Hunan, China
NOT_YET_RECRUITINGSinapharm North Hospital
Baotou, Inner Mongolia, China
RECRUITING...and 9 more locations
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.
Time frame: Within 72 hours of intervention.
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.
Time frame: 0-30 days of intervention.
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.
Time frame: 0-30 days of intervention.
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).
Time frame: 0-90 days.
Rate of symptomatic intracerebral hemorrhage.
Time frame: 0-90 days
Number of Participants experienced adverse events
Time frame: 0-90 days.
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