A Study Evaluating the Safety and Efficacy of Tirofiban in Combination With Alteplase in Acute Ischemic Stroke (RESET)
Acute Ischemic Stroke
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Acute Ischemic Stroke, Tirofiban
Eligibility Criteria
Inclusion Criteria:
- According to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018, the patient is clinically diagnosed as acute ischemic stroke;
- ≥ 18 years of age, regardless of gender;
- Patients who have received or are scheduled to receive intravenous thrombolysis with alteplase, that is, receiving thrombolysis with alteplase within 4.5 hours of onset of ischemic stroke;
- Intravenous antiplatelet therapy is acceptable within 12 hours of receiving intravenous thrombolysis;
- NIHSS score: 4 ≤ screening period/baseline NIHSS score ≤ 25;
- Be able to engage in daily life independently before the onset of this ischemic stroke (mRS score: 0-1 point);
- The subject or his/her guardian participates voluntarily and signs the ICF.
Exclusion Criteria:
- Combined with atrial fibrillation or clear evidence of cardiogenic embolism (e.g., known left atrial/left ventricular mural thrombosis, etc.);
- CT suggests large-area anterior circulation infarction (ASPECT score is < 6 points or infarction volume is ≥ 70 mL or infarction area is > 1/3 of the middle cerebral artery blood supply area);
- Significant head trauma or stroke within 3 months prior to screening;
- Previous history of intracranial hemorrhage (e.g., subarachnoid hemorrhage, and intracerebral hemorrhage);
- Previous intracranial tumor, arteriovenous malformation or aneurysm;
- Intracranial or spinal surgery and biopsy within 3 months prior to screening;
- Prolonged or traumatic cardiopulmonary resuscitation (> 2 min), delivery within the past 10 days or recent puncture of a non-compression vessel (e.g., subclavian vein or jugular vein);
- Presence of active internal hemorrhage (e.g., gastrointestinal, urinary tract or retinal hemorrhage, etc.);
- Hemorrhagic tendency (including but not limited to): platelet count < 100 × 109/L during screening; heparin treatment within the last 48 hours and APTT exceeding the upper limit of laboratory normal value; oral administration of warfarin at the time of screening, INR > 1.7; oral administration of new anticoagulants; and using direct thrombin or factor Xa inhibitors;
- Hypertension is not controlled after active antihypertensive therapy: systolic blood pressure is ≥ 180 mmHg or diastolic blood pressure is ≥ 100 mmHg;
- Blood glucose concentration is < 50 mg/dL (2.8 mmol/L) or > 400 mg/dL (22.2 mmol/L);
- Severe liver damage, including liver failure, cirrhosis, portal hypertension (esophageal varices), and active hepatitis;
- Serious renal insufficiency (creatinine clearance rate is < 30 mL/min);
- Currently undergoing renal dialysis;
- Aortic dissection;
- Major surgery or serious trauma within 30 days prior to screening;
- Gastrointestinal or urethral hemorrhage within 30 days prior to screening;
- History of acute myocardial infarction within 3 months prior to screening;
- It is known at the time of screening that subjects plan to undergo coronary, carotid or peripheral arterial revascularization during the trial;
- Female subjects who are serum pregnancy test positive, pregnant/lactating women, or women of childbearing potential who plan to have a pregnancy during the 12-month period, or women of childbearing potential or male subjects who are unwilling to take appropriate contraceptive measures during the trial;
- Users who are known to be allergic or contraindicated to the investigational product;
- Life expectancy of < 6 months due to any advanced disease;
- Patients who have participated in drug or device trials within one month;
- Patients with poor peripheral venous filling who cannot establish two standard peripheral venous lines;
- Stroke accompanied by seizures;
- Other conditions that the investigator considers inappropriate for participation in the clinical study, such as inability to understand and/or follow the study procedures and/or follow-up due to mental disorders, cognitive or emotional disorders.
Sites / Locations
- 23rd Floor, City Square, No.160 Qiaokou Road, Qiaokou District
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Tirofiban 0.25μg/kg/min(0.005ml/kg/min) group
Tirofiban 0.4μg/kg/min(0.008ml/kg/min) group
0.9% sodium chloride solution
The tirofiban hydrochloride sodium chloride injection is pumped intravenously at a constant rate of 0.25μg/kg/min (0.005 ml/kg/min) for 30 minutes, and then pumped intravenously at a constant rate of 0.1 μg/kg/min (0.002 ml/kg/min) for 24 hours.
The tirofiban hydrochloride sodium chloride injection is pumped intravenously at a constant rate of 0.4 μg/kg/min (0.008 ml/kg/min) for 30 minutes, and then pumped intravenously at a constant rate of 0.1 μg/kg/min (0.002 ml/kg/min) for 24 hours.
The placebo is pumped intravenously at a constant rate of 0.008 ml/kg/min for 30 minutes, and then pumped intravenously at a constant rate of 0.002 ml/kg/min for 24 hours.