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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke Patients
• Intervention / Treatment: Drug: low-dose tenecteplase intravenous thrombolysis; Drug: standard-dose tenecteplase intravenous thrombolysis

• Study Type: Interventional
• Enrollment (Estimated): 798
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hou Xianhua; Phone Number: 86-13594020663; Email: houxianhua@tmmu.edu.cn

Study Locations

• China
  • Anshan, China
    • Not yet recruiting
    • Anshan Changda Hospital
    • Contact: Nan Kong; Phone Number: +86 0412 8773602
  • Anyang, China
    • Recruiting
    • Huaxian People's Hospital of Henan
    • Contact: Hongling Guo; Phone Number: +86 0372 8172259; Email: guohongling11@163.com
  • Anyang, China
    • Recruiting
    • Anyang People's Hospital
    • Contact: Jiangang Zhang; Phone Number: +86 0372 3335119
  • Baoshan, China
    • Not yet recruiting
    • Baoshan People's Hospital
    • Contact: Yulong Sun; Phone Number: +86 0875 2122054
  • Bijie, China
    • Not yet recruiting
    • People's Hospital of Zhijin County
    • Contact: Hongyun Yang; Phone Number: +86 0857 7622140
  • Chongqing, China
    • Not yet recruiting
    • Chongqing University Three Gorges Hospital
    • Contact: Shengli Chen; Phone Number: +86 023 58103215
  • Chongqing, China
    • Not yet recruiting
    • Bishan Hospital
    • Contact: Changqing Zhou; Phone Number: +86 023 41411312
  • Chongqing, China
    • Not yet recruiting
    • Dianjiang People's Hospital OF Chongqing
    • Contact: Lin Chen; Phone Number: +86 023 85653444
  • Chongqing, China
    • Not yet recruiting
    • People's Hospital Of Xiushan County
    • Contact: Xiaopeng Feng; Phone Number: +86 023 76662176
  • Chongqing, China
    • Not yet recruiting
    • The People's Hospital of Dazu Chongqing
    • Contact: Xianming Tao; Phone Number: +86 023 43780184
  • Chongqing, China
    • Recruiting
    • Chongqing University Fuling Hospital
    • Contact: De Yang; Phone Number: +86 023 72234241
  • Chongqing, China
    • Recruiting
    • Chongqing University Jiangjin Hospital
    • Contact: Zuowen Zhang; Phone Number: +86 023 47524120
  • Chongqing, China
    • Recruiting
    • The People's Hospital of Rongchang Chongqing
    • Contact: Hongyuan Cao; Phone Number: +86 023 46732020
  • Chongqing, China
    • Recruiting
    • The Seventh People's Hospital of Chongqing
    • Contact: Yong Tan; Phone Number: +86 023 62850631
  • Chongqing, China
    • Recruiting
    • Tongliang Hospital
    • Contact: Qiang Li; Phone Number: +86 023 45656089
  • Chongqing, China
    • Recruiting
    • Yunyang County People's Hospital
    • Contact: Chibo Ai; Phone Number: +86 023 55120123
  • Chongqing, China
    • Recruiting
    • Chongqing Emergency Medical Center
    • Contact: Liu Yang; Phone Number: +86 023 63692253
  • Chongqing, China
    • Recruiting
    • The People's Hospital of Tongnan District Chongqing City
    • Contact: Changjiang Chen; Phone Number: +86 023 44551535
  • Chongqing, China
    • Recruiting
    • The People's Hospital of HeChuan, Chongqing
    • Contact: Haihua Li; Phone Number: +86 023 42713201
  • Dali, China
    • Not yet recruiting
    • Dali Bai Autonomous Prefecture People's Hospital
    • Contact: Shibo Han; Phone Number: +86 0872 2125465
  • Dazhou, China
    • Not yet recruiting
    • Dazhou Central Hospital
    • Contact: Haochun Zhang; Phone Number: +86 0818 2371651
  • Deyang, China
    • Not yet recruiting
    • The People's Hospital of Zhongjiang
    • Contact: Xingguo Zhang; Phone Number: +86 0838 7895120
  • Guang’an, China
    • Not yet recruiting
    • Guang an People's Hospital
    • Contact: Jun Liu; Phone Number: +86 0826 2600242
  • Guiyang, China
    • Not yet recruiting
    • Guizhou Provincial People's Hospital
    • Contact: Xiao Hu; Phone Number: +86 0851 5922979
  • Guiyang, China
    • Not yet recruiting
    • The Second People's Hospital of Guiyang（Guiyang Jinyang Hospital）
    • Contact: Zhongyong Peng; Phone Number: +86 0851-8799382
  • Ha’erbin, China
    • Not yet recruiting
    • The First Affiliated Hospital of Harbin Medical University
    • Contact: Zhongling Zhang; Phone Number: +86 0451 85556000; Email: zhang777hyd@163.com
  • Hebi, China
    • Recruiting
    • Xunxian People's Hospital
    • Contact: Beihai Jiang; Phone Number: +86 0392 8299995
  • Heyuan, China
    • Not yet recruiting
    • Heyuan People's Hospital
    • Contact: Minzhen Zhu; Phone Number: +86 0762 3185200
  • Huanggang, China
    • Recruiting
    • Qichun People's Hosiptal
    • Contact: Yong Wu; Phone Number: +86 713 7308888
  • Jianyang, China
    • Not yet recruiting
    • The People's Hospital Of Jianyang City
    • Contact: Zhong Fu; Phone Number: +86 028 27017805
  • Laixi, China
    • Not yet recruiting
    • Laixi People's Hospital
    • Contact: Huansong Wang; Phone Number: +86 0532 82716767
  • Leshan, China
    • Not yet recruiting
    • People's Hospital of Leshan
    • Contact: Huiying Huang; Phone Number: +86 0833 2119304
  • Leshan, China
    • Recruiting
    • Leshan Geriatric Specialized Hospital
    • Contact: Mingli Zeng; Phone Number: +86 833 2137100
  • Luoyang, China
    • Recruiting
    • Luoyang Mengjin People's Hospital
    • Contact: Haojin Zhao; Phone Number: +86 0379 67921111
  • Nanchong, China
    • Recruiting
    • Nanbu People's Hospital
    • Contact: Yi Tu; Phone Number: +86 0817 5522762
  • Pujiang, China
    • Not yet recruiting
    • Puyang People's Hospital
    • Contact: Jintao Guo; Phone Number: +86 0393 8779900
  • Pujiang, China
    • Recruiting
    • The People's Hospital of Nan Le Xian
    • Contact: Tingting Zhang; Phone Number: +86 0393 6226120
  • Shangqiu, China
    • Recruiting
    • The First People's Hospital of Shangqiu
    • Contact: Quande Dai; Phone Number: +86 0370 3255630
  • Shangqiu, China
    • Recruiting
    • People's Hospital of Ningling County
    • Contact: Zhixiang Sui; Phone Number: +081-03707770798
  • Shaoyang, China
    • Recruiting
    • The First People ' S Hospital of Shao Yang
    • Contact: Huafei Liu; Phone Number: +86 0739 5224301
  • Shijiazhuang, China
    • Recruiting
    • The People's Hospital of Gaocheng
    • Contact: Hongjuan Wang; Phone Number: +86 88120999
  • Wuhan, China
    • Recruiting
    • Wuhan Puren Hospital
    • Contact: Fengguang Li; Phone Number: +86 027 86868999
  • Xiangyang, China
    • Recruiting
    • Xiangyang No.1 People's Hospital
    • Contact: Peiyang Zhou; Phone Number: +86 0710 3425180
  • Yibin, China
    • Recruiting
    • The Second People's Hospital of Yibin
    • Contact: Qin Liu; Phone Number: +86 0831 8252118
  • Zhumadian, China
    • Recruiting
    • Zhumadian Central Hospital
    • Contact: Wenxian Feng; Phone Number: +86 0396 965558; Email: fengwenxian777@126.com
  • Zhuzhou, China
    • Not yet recruiting
    • ZhuZhou Central Hospital
    • Contact: Sizhi Tang; Phone Number: +86 0731 28561122
  • Zigong, China
    • Recruiting
    • Zigong Third People's Hospital
    • Contact: Bo Zheng; Phone Number: +86 0813 3319575
  • Ziyang, China
    • Not yet recruiting
    • Ziyang Central Hospital
    • Contact: Haizhi Guo; Phone Number: +86 028 26052520
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400038
      • Recruiting
      • Southwest Hospital, Chongqing, China
      • Contact: Zhenhua Zhou; Phone Number: +86 023 6875471; Email: zhouzhenhua@tmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-Dose Tenecteplase; 0.175mg/kg tenecteplase	Drug: 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.
Active Comparator: Standard-Dose Tenecteplase; 0.25mg/kg tenecteplase	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1	Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death).	At Day 90±7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	National Institutes of Health Stroke Scale (NIHSS) is a 11-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 6 grades with 0 as normal, and there is an allowance for untestable items.Total NIHSS score (0-42) = sum of 11 individual item scores, higher total scores meaning more severe deficits.	At 24 hours
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2	Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death).	At Day 90±7 days
Distribution of Modified Rankin Scale (mRS)	Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death).	At Day 90±7 days
Percentage of Participants With Barthel Index Score ≥95	The Barthel Index is an ordinal scale used to measure performance in activities of daily living (ADL). The Barthel Index consists of 10 items. The total score of the Barthel Index ranges from 0 to 100, and higher scores indicate better outcome.	up to 90 days
EQ-5D-5L score	Health-related quality of life (the score on the EuroQol Group 5-Dimension 5-Level [EQ-5D-5L] questionnaire, range, -0.39 to 1, with higher scores indicating better quality of life)	At Day 90±7 days
Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH)	sICH via criteria adapted from the European Cooperative Acute Stroke Study (ECASS III), defined as any apparent extravascular blood in the brain or within the cranium that is associated with clinical deterioration defined by an NIHSS score increase of four points or more from baseline.	up to 36 hours
All-cause mortality	All-cause mortality at 90 days	up to 90 days
Percentage of Participants With Modified Rankin Scale (mRS) Score of 5 or 6	Modified Rankin Scale (mRS) is a standardized measure that describes the extent of disability after a stroke. The mRS is a single item scale. It increases from 0 (no symptoms at all) to 6 (death).	At Day 90±7 days

Collaborators and Investigators

• Sponsor: Southwest Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025IITDA10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No