Low-Dose Tenecteplase for Acute Ischemic Stroke Treatment in Aging Patients

Официальное название

Efficacy and Safety of Low-Dose Tenecteplase for Acute Ischemic Stroke Treatment in Aging Patients: A Prospective, Multicenter, Randomized Controlled Study

Обзор

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.

Вмешательства

• Препарат low-dose tenecteplase intravenous thrombolysis
  Subjects will be randomized to low-dose group or standard-dose group in a 1:1 ratio. Patients in the low-dose group received tenecteplase (0.175 mg/kg) for intravenous thrombolysis. The upper dose limit is set to 17.5 mg/patient.
• Препарат standard-dose tenecteplase intravenous thrombolysis
  Subjects will be randomized to low-dose group or standard-dose group in a 1:1 ratio. Patients in the standard-dose group received tenecteplase (0.25 mg/kg) for intravenous thrombolysis. The upper dose limit is set to 25 mg/patient.

Первичные конечные точки

• Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1 [Срок оценки: At Day 90±7 days]

Вторичные конечные точки (8)

• 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) [Срок оценки: At 24 hours]
• Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2 [Срок оценки: At Day 90±7 days]
• Distribution of Modified Rankin Scale (mRS) [Срок оценки: At Day 90±7 days]
• Percentage of Participants With Barthel Index Score ≥95 [Срок оценки: up to 90 days]
• EQ-5D-5L score [Срок оценки: At Day 90±7 days]
• Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH) [Срок оценки: up to 36 hours]
• All-cause mortality [Срок оценки: up to 90 days]
• Percentage of Participants With Modified Rankin Scale (mRS) Score of 5 or 6 [Срок оценки: At Day 90±7 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 51 центр

• Southwest Hospital, Chongqing, China — Чунцин
• Wuchang People's Hospital — Харбин
• Shenqiu County People's Hospital — Zhoukou
• Anshan Changda Hospital — Anshan
• Anyang People's Hospital — Anyang
• Huaxian People's Hospital of Henan — Anyang
• Baoshan People's Hospital — Baoshan
• People's Hospital of Zhijin County — Bijie
• … и ещё 43 центра

Идентификаторы

NCT: NCT07294209 · 2025IITDA10

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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