NCT07294209招募中4 期
Efficacy and Safety of Low-Dose Tenecteplase for Acute Ischemic Stroke Treatment in Aging Patients: A Prospective, Multicenter, Randomized Controlled Study
Southwest Hospital, China104 个研究点 分布在 1 个国家目标入组 798 人开始时间: 2025年12月19日最近更新:
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 798
- 试验地点
- 104
- 主要终点
- Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1
研究概览
简要总结
The DATE-AGING study is a prospective, multicenter, randomized controlled trial investigating low-dose tenecteplase in elderly patients with acute ischemic stroke. Its primary objective is to evaluate the safety and efficacy of low-dose tenecteplase in elderly patients within 4.5 hours of acute ischemic stroke onset.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 70 years;
- •Diagnosis of ischaemic stroke with a measurable neurological deficit on National Institutes of Health Stroke Scale (NIHSS) (1≤ NIHSS ≤25); if NIHSS <4, patients have to be with at least a measurable deficit on motor power (upper or lower limbs ≥1);
- •Stroke symptoms should have been present for at least 30 minutes (min) without significant improvement prior to randomisation;
- •Thrombolytic therapy can be initiated within 4.5 Hour(s) (h) of Acute ischaemic stroke (AIS) onset;
- •Patients with premorbid modified Rankin Scale (mRS) 0 or 1;
- •Informed consent from the patient or surrogate.
排除标准
- •Imaging demonstrates multi-lobar infarction (hypodensity >1/3 cerebral hemisphere);
- •Acute bleeding diathesis or allergy to tenecteplase, including but not limited to
- •Known genetic predisposition to bleeding or significant bleeding disorder at present or within the past 6 Month(s) (m)
- •Administration of heparin within the previous 48 h and activated partial thromboplastin time (aPTT) exceeding the upper limit of normal for laboratory measurement
- •Current use of vitamin K based oral anticoagulants (e.g. warfarin) and a prolonged prothrombin time (International normalised Ratio (INR) > 1.7 or Prothrombin time (PT)>15 seconds (s)) or current use of novel oral anticoagulants (i.e. dabigitran, rivaroxiban, or apixiban) with prolongation of activated partial thromboplastin time (aPTT) and/or PT above the upper limit of the local laboratory reference range
- •Platelet count of below 100×10^9/ L
- •Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
- •Recent traumatic external heart massage or recent puncture of a non-compressive blood-vessel (e.g. subclavian or jugular vein puncture) , within the past 10 days
- •Known history of suspected intracranial haemorrhage or suspected subarachnoid haemorrhage from aneurysm
- •Neoplasm with increased haemorrhagic risk
- •Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial aneurysm, or arterial/venous malformations
- •History of significant trauma or major surgery within the past 3 months.
- •Any known disorder associated with a significant increased risk of bleeding
- •Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.);
- •Blood glucose <2.8 mmol/L or >22.22 mmol/L;
- •After active antihypertensive treatment, hypertension is still not under control: systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥100 mmHg;
- •Seizure at stroke onset;
- •Concurrent malignancy or severe systemic disease with an anticipated survival of less than 90 days;
- •Participation in other clinical trials within 3 months prior to screening;
- •Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk.
研究组 & 干预措施
Low-Dose Tenecteplase
Experimental
0.175mg/kg tenecteplase
干预措施: low-dose tenecteplase intravenous thrombolysis (Drug)
Standard-Dose Tenecteplase
Active Comparator
0.25mg/kg tenecteplase
干预措施: standard-dose tenecteplase intravenous thrombolysis (Drug)
结局指标
主要结局
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1
时间窗: At Day 90±7 days
Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death).
次要结局
- Percentage of participants with major neurological improvement (National Institutes of Health Stroke Scale (NIHSS) score of 0 or improvement of at least 4 points compared with baseline)(At 24 hours)
- Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2(At Day 90±7 days)
- Distribution of Modified Rankin Scale (mRS)(At Day 90±7 days)
- Percentage of Participants With Barthel Index Score ≥95(up to 90 days)
- EQ-5D-5L score(At Day 90±7 days)
- Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH)(up to 36 hours)
- All-cause mortality(up to 90 days)
- Percentage of Participants With Modified Rankin Scale (mRS) Score of 5 or 6(At Day 90±7 days)
研究者
Zhenhua Zhou
Professor
Southwest Hospital, China
研究点 (104)
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