Status:
UNKNOWN
A Study Evaluating the Safety and Efficacy of Tirofiban in Combination With Alteplase in Acute Ischemic Stroke
Lead Sponsor:
GrandPharma (China) Co., Ltd.
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The study is a prospective, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of tirofiban in combination with intravenous thrombolytic therapy with al...
Detailed Description
Ischemic stroke is a common disease of nervous system, with high morbidity, mortality and disability, which seriously threatens human health. According to the latest global burden of disease research,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT05188417
Start Date
December 9 2021
End Date
June 30 2023
Last Update
February 23 2023
Active Locations (1)
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1
23rd Floor, City Square, No.160 Qiaokou Road, Qiaokou District
Wuhan, Hubei, China, 430032