NCT07242599尚未招募3 期
A Multicenter, Randomized, Open-label, Parallel-controlled, Event-driven, Blinded-endpoint Trial Evaluating the Efficacy and Safety of Ongericimab Injection in High-risk Stroke Patients With Intracranial or Extracranial Atherosclerotic Stenosis.
Beijing Tiantan Hospital197 个研究点 分布在 1 个国家目标入组 4,810 人开始时间: 2026年4月22日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4,810
- 试验地点
- 197
- 主要终点
- The major cardiovascular events
研究概览
简要总结
The Oris trial aims to evaluate whether the use of Ongericimab injection in patients with atherosclerotic ischemic cerebrovascular disease within 3 months of onset can reduce the risk of recurrent major cardiovascular events by achieving lower lipid-lowering target values (LDL-C < 1.4 mmol/L).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obtaining informed consent；
- •Age ≥18 years；
- •Patients with ischemic stroke within 3 months( NIHSS<15 before randomization);
- •Presence of ≥50% stenosis in major intracranial or extracranial arteries, and related to the symptoms of the current episode or the location of infarction；
- •LDL-C ≥ 70 mg/dL (1.8 mmol/L) at screening.
排除标准
- •History of cerebral hemorrhage at any time (microhemorrhages present only on SWI are not an exclusion criterion)
- •Hemorrhage or other pathological neurological conditions on baseline brain CT/MRI (e.g., vascular malformations, tumors, abscesses, or common non-ischemic brain diseases like multiple sclerosis);
- •Presence of isolated sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness or vertigo, but no evidence of recent infarction on baseline head CT or MRI;
- •Unable to complete the assessment of intracranial and extracranial arterial stenosis before randomization
- •mRS score≥2 before onset (based on assessment of medical history);
- •Stroke caused by angioplasty/vascular surgery;
- •Cardioembolic stroke caused by atrial fibrillation, artificial heart valves, endocarditis, mitral stenosis, sinus node dysfunction, etc.
- •Most recent fasting triglycerides >400 mg/dL (4.5 mmol/L) prior to randomization;
- •Uncontrolled hypertension (SBP >180 mmHg or DBP >110 mmHg);
- •Hypothyroidism diagnosed within 1 month before randomization.
- •Severe renal impairment (eGFR <30 mL/min/1.73m²);
- •Active liver disease or dysfunction (AST/ALT >3×ULN within 30 days pre-randomization);
- •NYHA Class III/IV heart failure within 1 year prior to randomization;
- •Life-limiting non-cardiovascular diseases (life expectancy <1 years);
- •Malignancy within 10 years (excluding adequately treated basal cell carcinoma, cervical CIS, DCIS, or stage 1 prostate cancer);
- •Known hypersensitivity to monoclonal antibody therapies;
- •PCSK9 inhibitor use within 3 months before randomization.
- •Participation in other drug/device trials within 30 days;
- •Women of childbearing potential without contraception, pregnancy, or lactation;
- •Inability to understand or comply with the study due to mental illness, cognitive, or emotional disorders, or other reasons deemed unsuitable for participation in the study by the investigator.
研究组 & 干预措施
Control group (High target group)
Active Comparator
Standardized lipid-lowering therapy according to the Chinese Stroke Association Guidelines for Clinical Management of Cerebrovascular Diseases to achieve an LDL-C target below 70 mg/dL (1.8 mmol/L).
干预措施: High target group (Combination Product)
Intervention group (Low target group)
Experimental
Ongericimab subcutaneous injection once every two weeks (150mg) or every four weeks(300mg) combined with standardized lipid-lowering therapy to achieve an LDL-C target below 55 mg/dL (1.4 mmol/L)
干预措施: Low target group (Combination Product)
结局指标
主要结局
The major cardiovascular events
时间窗: A median of 2 years follow-up
The composite primary end point of major cardiovascular events includes ischemic stroke, myocardial infarction, death from cardiovascular causes.
次要结局
- Myocardial infarction(A median of 2 year follow-up)
- Vascular death(A median of 2 years follow-up)
- New ischemic stroke(A median follow-up of 2 years)
- Poor functional prognosis (mRS score > 1) at 1 year(A median of 2 years follow-up)
- Absolute and percent changes in Lp(a) levels.(A median of 2 years follow-up)
- Severity of new stroke(A median of 2 years follow-up)
- Absolute and percent changes in LDL-C levels(A median of 2 years follow-up)
- Treatment-emergent serious adverse events (SAEs) and adverse events (AEs)(A median of 2 years follow-up)
研究者
Yongjun Wang
President of Beijing Tiantan Hospital, Capital Medical University, Professor in Neurology
Beijing Tiantan Hospital
研究点 (197)
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