Low-Dose Tenecteplase for Acute Ischemic Stroke Treatment in Aging Patients (DATE-AGING)

Army Medical University

Status and phase: Enrolling; Phase 4

Conditions: Acute Ischemic Stroke Patients

Treatments: Drug: standard-dose tenecteplase intravenous thrombolysis; Drug: low-dose tenecteplase intravenous thrombolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT07294209

2025IITDA10

Details and patient eligibility

About

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.

Enrollment: 798 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 70 years;
2. 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);
3. Stroke symptoms should have been present for at least 30 minutes (min) without significant improvement prior to randomisation;
4. Thrombolytic therapy can be initiated within 4.5 Hour(s) (h) of Acute ischaemic stroke (AIS) onset;
5. Patients with premorbid modified Rankin Scale (mRS) 0 or 1;
6. Informed consent from the patient or surrogate.

Exclusion criteria

1. Imaging demonstrates multi-lobar infarction (hypodensity >1/3 cerebral hemisphere);

2. 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

3. Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.);

4. Blood glucose <2.8 mmol/L or >22.22 mmol/L;

5. After active antihypertensive treatment, hypertension is still not under control: systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥100 mmHg;

6. Seizure at stroke onset;

7. Concurrent malignancy or severe systemic disease with an anticipated survival of less than 90 days;

8. Participation in other clinical trials within 3 months prior to screening;

9. Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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798 participants in 2 patient groups

Low-Dose Tenecteplase

Experimental group

Description:

0.175mg/kg tenecteplase

Treatment:

Drug: low-dose tenecteplase intravenous thrombolysis

Standard-Dose Tenecteplase

Active Comparator group

Description:

0.25mg/kg tenecteplase

Treatment:

Drug: standard-dose tenecteplase intravenous thrombolysis