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NCT07294209

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

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

798 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-19

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Ischemic Stroke Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

multicenter, prospective, randomized, open label, blinded-endpoint (PROBE)，Parallel controls，Non-inferiority

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard-Dose Tenecteplase

0.25mg/kg tenecteplase

Group Type ACTIVE_COMPARATOR

standard-dose tenecteplase intravenous thrombolysis

Intervention Type DRUG

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.

Low-Dose Tenecteplase

0.175mg/kg tenecteplase

Group Type EXPERIMENTAL

low-dose tenecteplase intravenous thrombolysis

Intervention Type DRUG

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.

Interventions

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low-dose tenecteplase intravenous thrombolysis

Intervention Type DRUG

standard-dose tenecteplase intravenous thrombolysis

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Zhenhua Zhou

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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