Safety and Efficacy of Tirofiban in Preventing Neurological Deterioration of Patients With Acute Ischemic Stroke: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 420
- Locations
- 19
- Primary Endpoint
- Number of patients with a change in NIHSS by ≥ 4 points compared to enrollment NIHSS.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Oral antiplatelet therapy
Patients will receive oral antiplatelet therapy alone.
Intervention: Oral antiplatelet (Drug)
Tirofiban+Oral antiplatelet therapy
Patients will receive Tirofiban in the first 72 hours and bridge to oral antiplatelet therapy thereafter.
Intervention: Tirofiban Hydrochloride (Drug)
Tirofiban+Oral antiplatelet therapy
Patients will receive Tirofiban in the first 72 hours and bridge to oral antiplatelet therapy thereafter.
Intervention: Oral antiplatelet (Drug)
Outcomes
Primary Outcomes
Number of patients with a change in NIHSS by ≥ 4 points compared to enrollment NIHSS.
Time Frame: 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 Outcomes
- Change of the NIHSS(0-30 days of intervention.)
- Change of the Scandinavian Stroke Scale(0-30 days of intervention.)
- 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.)
Investigators
Ji Xunming,MD,PhD
Professor
Capital Medical University