Ischemic Stroke, Acute Clinical Trial
Official title:
Tirofiban for Patients With intraCranial Artery Stenosis and High-risk Acute Non-disabling Cerebrovascular Events(CHANCE-4）
The CHANCE-4 study is a multicenter, double-blind, double-simulation, randomized controlled study. In patients at high-risk for mild ischemic stroke or transient ischemic attack with symptomatic intracranial artery stenosis within 24 hours of onset, we will examine whether treatment with tirofiban for 48 hours reduce the risk of ischemic stroke recurrence within 90 days compared with placebo.
| Status | Not yet recruiting |
| Enrollment | 4674 |
| Est. completion date | June 2026 |
| Est. primary completion date | June 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility | Inclusion Criteria: - 1.40 years or older than 40 years. 2.Acute cerebral ischemic event due to: Acute mild ischemic stroke (NIHSS=5 at the time of randomization) or TIA with moderate-to-high risk of stroke (ABCD2 score = 6 at the time of randomization). 3.Symptomatic intracranial artery stenosis (symptomatic intracranial artery stenosis is defined as =50% stenosis of the supplying artery of the infarct lesion). 4.Can be treated with study drug within 24 hours of symptoms onset*(*Symptom onset is defined by the "last seen normal" principle). 5.Informed consent signed. Exclusion Criteria: 1. Diagnosis of bleeding or other pathological brain disorders, such as vascular malformations, tumors, abscesses, or other common non-ischemic brain diseases (such as multiple sclerosis) based on baseline head CT or MRI. 2. Evaluation of intracranial arterial stenosis could not be completed before randomization. 3. Isolated or pure sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on baseline head CT or MRI. 4. Iatrogenic causes (angioplasty or surgery) of stroke or TIA. 5. Pre-onset mRS Score >2(According to the assessment of patients' pre-onset history, patients with mRS>2 pre-onset cannot be enrolled). 6. Contraindications to tirofiban. 6.1 Known allergy history. 6.2 Severe renal (creatinine exceeding 1.5 times of the upper limit of normal range) or hepatic (ALT or AST > twice the upper limit of normal range) insufficiency. 6.3 Severe cardiac failure (NYHA level: III to IV). 6.4 History of hemostatic disorder or systemic bleeding. 6.5 History of thrombocytopenia or neutropenia. 6.6 History of drug-induced hematologic disorder or hepatic dysfunction. 6.7 Low white blood cell (<2×109/L) or platelet count (<100×109/L). 7. Tirofiban has been used since the onset of the disease. 8. Hematocrit (HCT) <30%. 9. Clear indication for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis). 10. History of intracranial hemorrhage or amyloid angiopathy. 11. History of aneurysm (including intracranial aneurysm and peripheral aneurysm). 12. History of asthma or COPD (chronic obstructive pulmonary disease). 13. High risk chronic arrhythmias such as diseased sinus syndrome, second or third degree atrioventricular block, bradycardia related syncope without pacemaker. 14. Surgical or endovascular treatment is expected in the next three months. 15. Other planned surgical procedures or interventional treatments may require discontinuation of antiplatelet medication. 16. Severe non-cardiovascular comorbidity with life expectancy < 3 months. 17. Inability to understand and/or follow research procedures due to mental, cognitive, or emotional disorders. 18. Used heparin or oral anticoagulants within 10 days before enrollment. 19. Patients who had undergone intravenous or arterial thrombolysis or mechanical thrombolysis within 24 hours before enrollment. 20. Large cerebral infarction (infarction area exceeding 1/2 responsible artery supply area). 21. Gastrointestinal bleed within 3 months or major surgery within 30 days. 22. Diagnosis or suspicious diagnosis of acute coronary syndrome. 23. Participation in another clinical study with an experimental product during the last 30 days. 24. Currently receiving an experimental drug or device. 25. Women of childbearing age, pregnant or lactating women who refuse to use effective contraception after a negative pregnancy test. |
| Country | Name | City | State |
|---|---|---|---|
| China | People's Hospital of Qihe County | Dezhou | Shandong |
| China | The 2nd Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang |
| China | Liaocheng People's Hospital(Liaocheng Brain Hospital) | Liaocheng | Shandong |
| China | Third People's Hospital of Liaocheng | Liaocheng | Shandong |
| China | Yantai Penglai traditional Chinese medicine hospital | Yantai | Shandong |
| Lead Sponsor | Collaborator |
|---|---|
| Beijing Tiantan Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | BARC type 3 or type 5 bleeding | BARC type 3 or type 5 bleeding within 1 year after randomization | Within 1 year after randomization | |
| Other | All bleeding events | All bleeding events (defined as BARC bleeding grades 1-5) within 3 months and 1 year after randomizatio,and simultaneously blood type will be evaluated independently | Within 3 months after randomization and 1 year after randomization | |
| Other | Death | Participants will be followed up according to the study protocol and deaths will be measured within 3 months and 1 year after randomization | Within 3 months after randomization and 1 year after randomization | |
| Other | Adverse events or serious adverse events | AE: An adverse event can therefore be any unfavourable and unintended sign, symptom,or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
SAE: Any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or signifcant disability/incapacity, acongenital anomaly/birth defect, results a major medical event that may harm the subject or require medical intervention to avoid the above outcomes. |
Within 3 months after randomization and 1 year after randomization | |
| Other | BARC type 2 or type 3 or 5 bleeding | BARC type 2 or type 3 or 5 bleeding within 3 months after randomization | Within 3 months after randomization and 1 year after randomization | |
| Primary | New ischemic stroke | The incidence of new ischemic stroke within 3 months after randomization | Within 3 months after randomization | |
| Primary | BARC type 3 or type 5 bleeding | BARC type 3 or type 5 bleeding within 3 months after randomization | Within 3 months after randomization | |
| Secondary | New ischemic stroke | The incidence of new ischemic stroke within 1 year after randomization | Within 1 year after randomization | |
| Secondary | Any new vascular events | New vascular events within 3 months and 1 year after randomization(Including ischemic stroke, hemorrhagic stroke, transient ischemic attack, myocardial infarction and vascular death),each new vascular event will be evaluated independently | Within 3 months after randomization and 1 year after randomization | |
| Secondary | Proportion of patients with disabling stroke | Proportion of patients with disabling stroke events (mRS Score >1) within 3 months and 1 year after randomization | Within 3 months after randomization and 1 year after randomization | |
| Secondary | Occurrence and severity of stroke or transient ischemic attack | The severity of stroke or transient ischemic attack will be assessed in conjunction with the mRS 6-level classification scale(fatal stroke/severe non-fatal stroke [mRS 4 or 5]/ moderate stroke[mRS 2 or 3]/ mild stroke [mRS 0 or 1]/TIA/No stroke -TIA)) | Within 3 months after randomization and 1 year after randomization | |
| Secondary | Proportion of patients with aggravated neurological impairment | The NIHSS score will increase at 3 months of follow-up compared to baseline High =4 points | At 3 months after randomization |