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
1 other identifier
interventional
798
1 country
49
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2025
Typical duration for phase_4
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2025
CompletedFirst Posted
Study publicly available on registry
December 19, 2025
CompletedStudy Start
First participant enrolled
December 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
April 23, 2026
April 1, 2026
3 years
November 21, 2025
April 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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)
At 24 hours
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2
At Day 90±7 days
Distribution of Modified Rankin Scale (mRS)
At Day 90±7 days
Percentage of Participants With Barthel Index Score ≥95
up to 90 days
EQ-5D-5L score
At Day 90±7 days
- +3 more secondary outcomes
Study Arms (2)
Low-Dose Tenecteplase
EXPERIMENTAL0.175mg/kg tenecteplase
Standard-Dose Tenecteplase
ACTIVE COMPARATOR0.25mg/kg tenecteplase
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Southwest Hospital, Chongqing, China
Chongqing, Chongqing Municipality, 400038, China
Anshan Changda Hospital
Anshan, China
Anyang People's Hospital
Anyang, China
Huaxian People's Hospital of Henan
Anyang, China
Baoshan People's Hospital
Baoshan, China
People's Hospital of Zhijin County
Bijie, China
Bishan Hospital
Chongqing, China
Chongqing Emergency Medical Center
Chongqing, China
Chongqing University Fuling Hospital
Chongqing, China
Chongqing University Jiangjin Hospital
Chongqing, China
Chongqing University Three Gorges Hospital
Chongqing, China
Dianjiang People's Hospital OF Chongqing
Chongqing, China
People's Hospital Of Xiushan County
Chongqing, China
The People's Hospital of Dazu Chongqing
Chongqing, China
The People's Hospital of HeChuan, Chongqing
Chongqing, China
The People's Hospital of Rongchang Chongqing
Chongqing, China
The People's Hospital of Tongnan District Chongqing City
Chongqing, China
The Seventh People's Hospital of Chongqing
Chongqing, China
Tongliang Hospital
Chongqing, China
Yunyang County People's Hospital
Chongqing, China
Dali Bai Autonomous Prefecture People's Hospital
Dali, China
Dazhou Central Hospital
Dazhou, China
The People's Hospital of Zhongjiang
Deyang, China
Guang an People's Hospital
Guang’an, China
Guizhou Provincial People's Hospital
Guiyang, China
The Second People's Hospital of Guiyang（Guiyang Jinyang Hospital）
Guiyang, China
The First Affiliated Hospital of Harbin Medical University
Ha’erbin, China
Xunxian People's Hospital
Hebi, China
Heyuan People's Hospital
Heyuan, China
Qichun People's Hosiptal
Huanggang, China
The People's Hospital Of Jianyang City
Jianyang, China
Laixi People's Hospital
Laixi, China
Leshan Geriatric Specialized Hospital
Leshan, China
People's Hospital of Leshan
Leshan, China
Luoyang Mengjin People's Hospital
Luoyang, China
Nanbu People's Hospital
Nanchong, China
Puyang People's Hospital
Pujiang, China
The People's Hospital of Nan Le Xian
Pujiang, China
People's Hospital of Ningling County
Shangqiu, China
The First People's Hospital of Shangqiu
Shangqiu, China
The First People ' S Hospital of Shao Yang
Shaoyang, China
The People's Hospital of Gaocheng
Shijiazhuang, China
Wuhan Puren Hospital
Wuhan, China
Xiangyang NO.1 People's Hospital
Xiangyang, China
The second people's hospital of Yibin
Yibin, China
Zhumadian Central Hospital
Zhumadian, China
Zhuzhou Central Hospital
Zhuzhou, China
Zigong Third People's Hospital
Zigong, China
Ziyang Central Hospital
Ziyang, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 21, 2025
First Posted
December 19, 2025
Study Start
December 19, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR