Low-Dose Tenecteplase for Acute Ischemic Stroke Treatment in Aging Patients
Efficacy and Safety of Low-Dose Tenecteplase for Acute Ischemic Stroke Treatment in Aging Patients: A Prospective, Multicenter, Randomized Controlled Study
Southwest Hospital, China
798 participants
Dec 19, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria20
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
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.
Locations(48)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07294209