Acute Ischemic Stroke PatientsPhase 4DATE-AGINGNCT07294209

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

A Phase 4 study testing low-dose tenecteplase intravenous thrombolysis and standard-dose tenecteplase intravenous thrombolysis in people with Acute Ischemic Stroke Patients, run by Southwest Hospital, China at 51 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 70 years and older
Conditions the study is for: Acute Ischemic Stroke Patients
What is being tested?: low-dose tenecteplase intravenous thrombolysis and standard-dose tenecteplase intravenous thrombolysis
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 798 participants
Where: 51 sitesChina
Study dates: 19 Dec 2025to 31 Dec 2028
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 70 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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.

Who cannot join

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

Show all 20Show fewer

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;
After active antihypertensive treatment, hypertension is still not under control: systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥100 mmHg;
Seizure at stroke onset;
Concurrent malignancy or severe systemic disease with an anticipated survival of less than 90 days;
Participation in other clinical trials within 3 months prior to screening;
Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk.

Trial locations and contacts

51 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Hou Xianhua contact

86-13594020663

houxianhua@tmmu.edu.cn

City, postcode or hospital

Sites recruiting now only

51 sites in 1 country

China51 sites, 51 recruiting

Anshan Changda Hospital
Anshan
Nan Kong, +86 0412 8773602
Not yet recruiting
Anyang People's Hospital
Anyang
Jiangang Zhang, +86 0372 3335119
Recruiting
Huaxian People's Hospital of Henan
Anyang
Hongling Guo, +86 0372 8172259, guohongling11@163.com
Recruiting
Baoshan People's Hospital
Baoshan
Yulong Sun, +86 0875 2122054
Not yet recruiting
People's Hospital of Zhijin County
Bijie
Hongyun Yang, +86 0857 7622140
Not yet recruiting
Southwest Hospital, Chongqing, China
Chongqing, Chongqing Municipality, 400038
Zhenhua Zhou, +86 023 6875471, zhouzhenhua@tmmu.edu.cn
Recruiting
Bishan Hospital
Chongqing
Changqing Zhou, +86 023 41411312
Not yet recruiting
Chongqing Emergency Medical Center
Chongqing
Liu Yang, +86 023 63692253
Recruiting
Chongqing University Fuling Hospital
Chongqing
De Yang, +86 023 72234241
Recruiting
Chongqing University Jiangjin Hospital
Chongqing
Zuowen Zhang, +86 023 47524120
Recruiting
Chongqing University Three Gorges Hospital
Chongqing
Shengli Chen, +86 023 58103215
Not yet recruiting
Dianjiang People's Hospital OF Chongqing
Chongqing
Lin Chen, +86 023 85653444
Recruiting
People's Hospital Of Xiushan County
Chongqing
Xiaopeng Feng, +86 023 76662176
Not yet recruiting
The People's Hospital of Dazu Chongqing
Chongqing
Xianming Tao, +86 023 43780184
Not yet recruiting
The People's Hospital of HeChuan, Chongqing
Chongqing
Haihua Li, +86 023 42713201
Recruiting
The People's Hospital of Rongchang Chongqing
Chongqing
Hongyuan Cao, +86 023 46732020
Recruiting
The People's Hospital of Tongnan District Chongqing City
Chongqing
Changjiang Chen, +86 023 44551535
Recruiting
The Seventh People's Hospital of Chongqing
Chongqing
Yong Tan, +86 023 62850631
Recruiting
Tongliang Hospital
Chongqing
Qiang Li, +86 023 45656089
Recruiting
Yunyang County People's Hospital
Chongqing
Chibo Ai, +86 023 55120123
Recruiting
Dali Bai Autonomous Prefecture People's Hospital
Dali
Shibo Han, +86 0872 2125465
Not yet recruiting
Dazhou Central Hospital
Dazhou
Haochun Zhang, +86 0818 2371651
Recruiting
The People's Hospital of Zhongjiang
Deyang
Xingguo Zhang, +86 0838 7895120
Not yet recruiting
Guang an People's Hospital
Guang’an
Jun Liu, +86 0826 2600242
Not yet recruiting
Guizhou Provincial People's Hospital
Guiyang
Xiao Hu, +86 0851 5922979
Not yet recruiting
The Second People's Hospital of Guiyang（Guiyang Jinyang Hospital）
Guiyang
Zhongyong Peng, +86 0851-8799382
Recruiting
The First Affiliated Hospital of Harbin Medical University
Ha’erbin
Zhongling Zhang, +86 0451 85556000, zhang777hyd@163.com
Not yet recruiting
Wuchang People's Hospital
Harbin, Heilongjiang, 150200
Meiying Xu, +86 451 5580 7009
Recruiting
Xunxian People's Hospital
Hebi
Beihai Jiang, +86 0392 8299995
Recruiting
Heyuan People's Hospital
Heyuan
Minzhen Zhu, +86 0762 3185200
Not yet recruiting
Qichun People's Hosiptal
Huanggang
Yong Wu, +86 713 7308888
Recruiting
The People's Hospital Of Jianyang City
Jianyang
Zhong Fu, +86 028 27017805
Not yet recruiting
Laixi People's Hospital
Laixi
Huansong Wang, +86 0532 82716767
Not yet recruiting
Leshan Geriatric Specialized Hospital
Leshan
Mingli Zeng, +86 833 2137100
Recruiting
People's Hospital of Leshan
Leshan
Huiying Huang, +86 0833 2119304
Not yet recruiting
Luoyang Mengjin People's Hospital
Luoyang
Haojin Zhao, +86 0379 67921111
Recruiting
Nanbu People's Hospital
Nanchong
Yi Tu, +86 0817 5522762
Recruiting
Puyang People's Hospital
Pujiang
Jintao Guo, +86 0393 8779900
Not yet recruiting
The People's Hospital of Nan Le Xian
Pujiang
Tingting Zhang, +86 0393 6226120
Recruiting
People's Hospital of Ningling County
Shangqiu
Zhixiang Sui, +081-03707770798
Recruiting
The First People's Hospital of Shangqiu
Shangqiu
Quande Dai, +86 0370 3255630
Recruiting
The First People ' S Hospital of Shao Yang
Shaoyang
Huafei Liu, +86 0739 5224301
Recruiting
The People's Hospital of Gaocheng
Shijiazhuang
Hongjuan Wang, +86 88120999
Recruiting
Wuhan Puren Hospital
Wuhan
Fengguang Li, +86 027 86868999
Recruiting
Xiangyang NO.1 People's Hospital
Xiangyang
Peiyang Zhou, +86 0710 3425180
Recruiting
The second people's hospital of Yibin
Yibin
Qin Liu, +86 0831 8252118
Recruiting
Shenqiu County People's Hospital
Zhoukou, Henan, 466300
Weidong Jia, +86 394 528 5508
Recruiting
Zhumadian Central Hospital
Zhumadian
Wenxian Feng, +86 0396 965558, fengwenxian777@126.com
Recruiting
Zhuzhou Central Hospital
Zhuzhou
Sizhi Tang, +86 0731 28561122
Not yet recruiting
Zigong Third People's Hospital
Zigong
Bo Zheng, +86 0813 3319575
Recruiting
Ziyang Central Hospital
Ziyang
Haizhi Guo, +86 028 26052520
Not yet recruiting

Other trials in China

About this study

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

Conditions: Acute Ischemic Stroke Patients
Being tested: low-dose tenecteplase intravenous thrombolysis, standard-dose tenecteplase intravenous thrombolysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

low-dose tenecteplase intravenous thrombolysisDrug
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.
standard-dose tenecteplase intravenous thrombolysisDrug
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.

Study groups in NCT07294209
Study group	Role	What they receive
Low-Dose Tenecteplase	Experimental	0.175mg/kg tenecteplase Receives: Drug: low-dose tenecteplase intravenous thrombolysis
Standard-Dose Tenecteplase	Active comparator	0.25mg/kg tenecteplase Receives: Drug: standard-dose tenecteplase intravenous thrombolysis

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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)
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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.
Measured: up to 36 hours
All-cause mortality
All-cause mortality at 90 days
Measured: 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).
Measured: At Day 90±7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Dec 202531 Dec 2028

First posted19 Dec 2025
Study start19 Dec 2025
Primary completion31 Dec 2028 (estimated)
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Ischemic Stroke PatientsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: multicenter, prospective, randomized, open label, blinded-endpoint (PROBE)，Parallel controls，Non-inferiority
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 798 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07294209
Sponsor's protocol ID: 2025IITDA10
Acronym: DATE-AGING
Status last verified: Jun 2026
First submitted: 21 Nov 2025
Last updated: 23 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Interested in taking part?

Hou Xianhua

86-13594020663

houxianhua@tmmu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Low-Dose Tenecteplase for Acute Ischemic Stroke Treatment in Aging Patients: A Prospective, Multicenter, Randomized Controlled Study
ClinicalTrials.gov ID: NCT07294209
Acronym / sponsor ID: DATE-AGING / 2025IITDA10
Conditions: Acute Ischemic Stroke Patients
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 798 participants (estimated)
Lead sponsor: Southwest Hospital, ChinaUniversity, hospital or other
Study start: 19 Dec 2025 (actual)
Primary completion: 31 Dec 2028 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 19 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: multicenter, prospective, randomized, open label, blinded-endpoint (PROBE)，Parallel controls，Non-inferiority

Arm	Type	Receives
Low-Dose Tenecteplase	Experimental	Drug: low-dose tenecteplase intravenous thrombolysis0.175mg/kg tenecteplase
Standard-Dose Tenecteplase	Active comparator	Drug: standard-dose tenecteplase intravenous thrombolysis0.25mg/kg tenecteplase

Who may qualify

Ages: 70 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (20 listed)

Imaging demonstrates multi-lobar infarction (hypodensity >1/3 cerebral hemisphere);
Acute bleeding diathesis or allergy to tenecteplase, including but not limited to
Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.);
Blood glucose <2.8 mmol/L or >22.22 mmol/L;
After active antihypertensive treatment, hypertension is still not under control: systolic blood pressure ≥180 mmHg, or diastolic blood pressure ≥100 mmHg;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
low-dose tenecteplase intravenous thrombolysisSubjects 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.	Drug	Low-Dose Tenecteplase
standard-dose tenecteplase intravenous thrombolysisSubjects 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.	Drug	Standard-Dose Tenecteplase

Primary outcome

Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1
Time frame: At Day 90±7 days
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).

8 secondary outcomes

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)
Time frame: At 24 hours
Percentage of Participants With Modified Rankin Scale (mRS) Score of 0-2
Time frame: At Day 90±7 days
Distribution of Modified Rankin Scale (mRS)
Time frame: At Day 90±7 days
Percentage of Participants With Barthel Index Score ≥95
Time frame: up to 90 days
EQ-5D-5L score
Time frame: At Day 90±7 days
Percentage of Participants With Symptomatic Intracerebral Haemorrhage (sICH)
Time frame: up to 36 hours
All-cause mortality
Time frame: up to 90 days
Percentage of Participants With Modified Rankin Scale (mRS) Score of 5 or 6
Time frame: At Day 90±7 days

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
Individual participant dataSharing planned: Yes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Hou Xianhua contact

86-13594020663

houxianhua@tmmu.edu.cn

51 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hou Xianhua (86-13594020663, houxianhua@tmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Modified Rankin Scale (mRS) Score of 0 or 1 (time frame: At Day 90±7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07294209.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.