Observational Registry of Effectiveness and Safety of Tenecteplase in Real World Settings in China-ORIENTAL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Favorable functional outcome at 90 days (modified Rankin Scale [mRS] score ≤1)
研究概览
简要总结
The ORIENTAL study is a prospective, multicenter, continuously enrolled real-world cohort designed to evaluate the effectiveness and safety of intravenous tenecteplase for acute ischemic stroke (AIS) in routine clinical practice across China. Approximately 10,000 patients from about 200 hospitals will be included. Eligible adults with imaging-confirmed AIS who receive tenecteplase as part of standard care will be consecutively enrolled and followed through 90 days. The study will describe patient characteristics, treatment processes, functional outcomes, and safety events, and will also explore inter-hospital variability and subgroup differences to support quality improvement and guide nationwide implementation of tenecteplase therapy.
详细描述
This real-world observational registry aims to generate comprehensive and high-quality evidence on the use of intravenous tenecteplase for acute ischemic stroke (AIS) in China following the national approval of the drug. Unlike randomized controlled trials with strict eligibility criteria, this study captures a broad clinical spectrum of patients and care settings, reflecting the actual patterns, challenges, and variations in stroke management across the country.
The registry is designed to provide insights into how tenecteplase performs in routine practice, including patients with multiple comorbidities, diverse stroke etiologies, and differing hospital capabilities. Consecutive enrollment and continuous data capture ensure representativeness and minimize selection bias.
Beyond describing effectiveness and safety, the study evaluates the real-world processes surrounding thrombolysis, including workflow metrics such as door-to-needle time and access to reperfusion resources. Analyses across different regions, hospital levels, and clinical subgroups will help identify practice gaps and opportunities for nationwide quality improvement. Comparisons with previous phase III trial populations, including the ORIGINAL study, will allow assessment of potential channeling bias and help interpret differences between clinical trial efficacy and real-world effectiveness.
The results of this registry will support clinical decision-making, inform guideline updates, and contribute to establishing standardized stroke care pathways for tenecteplase in China. The large sample size and national coverage are intended to ensure sufficient precision for outcome estimation and enable robust exploratory analyses that can guide future research and policy development.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adults aged 18 years or older;
- •Diagnosed with acute ischemic stroke confirmed by imaging (CT or MRI);
- •Treated with intravenous tenecteplase at the participating institution;
- •Provided written informed consent, signed by the patient or their legally authorized representative;
- •Capable of completing follow-up assessments.
排除标准
- •Received reperfusion therapy prior to the hospital admission (e.g., intravenous thrombolysis prior to admission);
- •Participating in any clinical trials where the intervention may affect the outcomes of this study.
研究组 & 干预措施
Tenecteplase-Treated AIS Cohort
干预措施: tenecteplase (Drug)
结局指标
主要结局
Favorable functional outcome at 90 days (modified Rankin Scale [mRS] score ≤1)
时间窗: 90 days
次要结局
- Functional independence at 90 days (mRS score of 0-2)(90 days)
- Ordinal mRS score at 90 days(90 days)
- Change in NIHSS score at 24 hours compared to baseline (short-term outcome)(24 hours)
- Change in NIHSS score at day 7 or discharge compared to baseline (short-term outcome)(7 days)
- Symptomatic intracranial hemorrhage (sICH) within 36 hours after intravenous thrombolysis(36 hours)
- All-cause mortality and time to death within 90 days(90 days)
- Stroke recurrence and time to recurrence within 90 days(90 days)
- Serious adverse events during hospitalization(7days)
研究者
Yongjun Wang
professor
Beijing Tiantan Hospital