Low-dose tenecteplase for acute ischemic stroke in older adults

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

This study will test whether giving a lower dose of tenecteplase within 4.5 hours helps people aged 70 and older who have had an acute ischemic stroke.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 798 (estimated)
• Ages: 70 Years and up
• Sex: All
• Sponsor: Southwest Hospital, China (Academic / other)
• Locations: 49 sites (Chongqing, Chongqing Municipality and 48 other locations)
• Trial ID: NCT07294209 on ClinicalTrials.gov

What this trial studies

DATE-AGING is a prospective, multicenter, randomized controlled trial comparing low-dose versus standard-dose intravenous tenecteplase given within 4.5 hours of stroke onset in patients aged 70 and older. Participants must have a measurable neurological deficit (NIHSS 1–25) and a premorbid modified Rankin Scale of 0–1. The trial's primary objective is to determine the safety and efficacy of the lower dose in this older population, with imaging exclusions for large multi-lobar infarction. Sites are located in Chongqing, Anshan, and Anyang, China, and enrollment requires informed consent from the patient or a surrogate.

Who should consider this trial

Good fit: Ideal candidates are people aged 70 or older with an acute ischemic stroke causing a measurable deficit (NIHSS 1–25), premorbid mRS 0–1, who can receive thrombolysis within 4.5 hours and can give informed consent or have a surrogate consent.

Not a fit: Patients with large multi-lobar infarcts, active bleeding disorders or allergies to tenecteplase, those on contraindicated anticoagulation, or anyone presenting beyond the 4.5-hour treatment window are unlikely to benefit from the trial intervention.

Why it matters

Potential benefit: If successful, this approach could provide safer clot‑busting treatment for older stroke patients by reducing bleeding risk while preserving recovery potential.

How similar studies have performed: Previous trials have shown tenecteplase can be promising compared with alteplase in some populations, but low-dose regimens specifically tested in very elderly patients are limited and not well established.

Eligibility criteria

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.

Where this trial is running

Chongqing, Chongqing Municipality and 48 other locations

• Southwest Hospital, Chongqing, China — Chongqing, Chongqing Municipality, China (Recruiting)
• Anshan Changda Hospital — Anshan, China (Not_yet_recruiting)
• Anyang People's Hospital — Anyang, China (Recruiting)
• Huaxian People's Hospital of Henan — Anyang, China (Recruiting)
• Baoshan People's Hospital — Baoshan, China (Not_yet_recruiting)
• People's Hospital of Zhijin County — Bijie, China (Not_yet_recruiting)
• Bishan Hospital — Chongqing, China (Not_yet_recruiting)
• Chongqing Emergency Medical Center — Chongqing, China (Recruiting)
• Chongqing University Fuling Hospital — Chongqing, China (Recruiting)
• Chongqing University Jiangjin Hospital — Chongqing, China (Recruiting)
• Chongqing University Three Gorges Hospital — Chongqing, China (Not_yet_recruiting)
• Dianjiang People's Hospital OF Chongqing — Chongqing, China (Not_yet_recruiting)
• People's Hospital Of Xiushan County — Chongqing, China (Not_yet_recruiting)
• The People's Hospital of Dazu Chongqing — Chongqing, China (Not_yet_recruiting)
• The People's Hospital of HeChuan, Chongqing — Chongqing, China (Recruiting)
• The People's Hospital of Rongchang Chongqing — Chongqing, China (Recruiting)
• The People's Hospital of Tongnan District Chongqing City — Chongqing, China (Recruiting)
• The Seventh People's Hospital of Chongqing — Chongqing, China (Recruiting)
• Tongliang Hospital — Chongqing, China (Recruiting)
• Yunyang County People's Hospital — Chongqing, China (Recruiting)
• Dali Bai Autonomous Prefecture People's Hospital — Dali, China (Not_yet_recruiting)
• Dazhou Central Hospital — Dazhou, China (Not_yet_recruiting)
• The People's Hospital of Zhongjiang — Deyang, China (Not_yet_recruiting)
• Guang an People's Hospital — Guang’an, China (Not_yet_recruiting)
• Guizhou Provincial People's Hospital — Guiyang, China (Not_yet_recruiting)
• The Second People's Hospital of Guiyang（Guiyang Jinyang Hospital） — Guiyang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Harbin Medical University — Ha’erbin, China (Not_yet_recruiting)
• Xunxian People's Hospital — Hebi, China (Recruiting)
• Heyuan People's Hospital — Heyuan, China (Not_yet_recruiting)
• Qichun People's Hosiptal — Huanggang, China (Recruiting)
• The People's Hospital Of Jianyang City — Jianyang, China (Not_yet_recruiting)
• Laixi People's Hospital — Laixi, China (Not_yet_recruiting)
• Leshan Geriatric Specialized Hospital — Leshan, China (Recruiting)
• People's Hospital of Leshan — Leshan, China (Not_yet_recruiting)
• Luoyang Mengjin People's Hospital — Luoyang, China (Recruiting)
• Nanbu People's Hospital — Nanchong, China (Recruiting)
• Puyang People's Hospital — Pujiang, China (Not_yet_recruiting)
• The People's Hospital of Nan Le Xian — Pujiang, China (Recruiting)
• People's Hospital of Ningling County — Shangqiu, China (Recruiting)
• The First People's Hospital of Shangqiu — Shangqiu, China (Recruiting)
• The First People ' S Hospital of Shao Yang — Shaoyang, China (Recruiting)
• The People's Hospital of Gaocheng — Shijiazhuang, China (Recruiting)
• Wuhan Puren Hospital — Wuhan, China (Recruiting)
• Xiangyang NO.1 People's Hospital — Xiangyang, China (Recruiting)
• The second people's hospital of Yibin — Yibin, China (Recruiting)
• Zhumadian Central Hospital — Zhumadian, China (Recruiting)
• Zhuzhou Central Hospital — Zhuzhou, China (Not_yet_recruiting)
• Zigong Third People's Hospital — Zigong, China (Recruiting)
• Ziyang Central Hospital — Ziyang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Hou Xianhua

Conditions Acute Ischemic Stroke Patients