ClinicalTrials.gg
CompletedNCT07294209DATE-AGINGUpdated Nov 3, 2026

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

A Phase 4 interventional study of low-dose tenecteplase intravenous thrombolysis and standard-dose tenecteplase intravenous thrombolysis in Acute Ischemic Stroke Patients, sponsored by Southwest Hospital, China. Completed at 51 sites in China. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Southwest Hospital, China · Phase 4, Interventional, and Treatment

Updated Nov 3, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
806
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 749 studies in Ischemic Stroke with a site in China — 376 open to participants now, 395 under way, 76 of them phase 3. Ischemic Stroke · China.

Enrollment
134th of 563
806 · median 266
Started
2025
with 106 others
Phase 4
70 of 749
31 open now
Registered
618th of 749
by date

Among the 749 studies in Ischemic Stroke with a site in China, this one is the 134th largest by enrollment of the 563 interventional ones that give a count, is one of 107 that started in 2025, is one of 70 in phase 4, and was the 618th registered.

Ischemic Stroke

2,617 studies on the registry are indexed under Ischemic Stroke; 976 are open to participants now.

Browse Ischemic Stroke studies →

Open to participants now

376 of the 749 studies in Ischemic Stroke with a site in China are open now. Recruiting first, the newest first:

371 more — sign in →

All 376 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 661 Ischemic Stroke studies recruiting now, 396 (60%) set no upper age limit and 62 (9%) stop at 75 or younger; 26 take children under 18; 42 take healthy volunteers.

This study: 70 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 749 studies in Ischemic Stroke with a site in China, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Acute Ischemic Stroke Patients

Browse trials for

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. from the patient or surrogate.

Exclusion criteria

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 (aPTT) exceeding the 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
    • 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 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
806 participants (actual)

Study arms

  • Experimental
    Low-Dose Tenecteplase

    0.175mg/kg tenecteplase

    Drug: low-dose tenecteplase intravenous thrombolysis

  • Active comparator
    Standard-Dose Tenecteplase

    0.25mg/kg tenecteplase

    Drug: standard-dose tenecteplase intravenous thrombolysis

Interventions

  • Druglow-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.

  • Drugstandard-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.

06

What researchers measure

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).

    Time frame: At Day 90±7 days

Secondary outcomes

  1. 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.

    Time frame: At 24 hours

  2. 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).

    Time frame: At Day 90±7 days

  3. 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).

    Time frame: At Day 90±7 days

  4. 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.

    Time frame: up to 90 days

  5. 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)

    Time frame: At Day 90±7 days

  6. 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.

    Time frame: up to 36 hours

  7. All-cause mortality

    All-cause mortality at 90 days

    Time frame: up to 90 days

  8. 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).

    Time frame: At Day 90±7 days

07

Study locations

51 sites
  • Southwest Hospital, Chongqing, China
    Chongqing, Chongqing Municipality 400038, China
  • Wuchang People's Hospital
    Harbin, Heilongjiang 150200, China
  • Shenqiu County People's Hospital
    Zhoukou, Henan 466300, 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
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2025 to primary completion in Nov 2026, 10 months.

Of 76 non-industry phase 4 interventional studies under Ischemic Stroke, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 42. This study's 10 months is below that.

Counting every sponsor, half of 85 studies reached it within 31 months; a quarter within 24 and three quarters within 41.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 3, 2026: primary completion Dec 2028 → Nov 2026 and completion Dec 2028 → Nov 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Nov 21, 2025
First posted
Dec 19, 2025
StartActual
Dec 19, 2025
Primary completionActual
Nov 1, 2026was Dec 2028
CompletionActual
Nov 1, 2026was Dec 2028
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Nov 3, 2026
Primary completion
Dec 31, 2028→Nov 1, 2026 (actual)
Nov 3, 2026
Study completion
Dec 31, 2028→Nov 1, 2026 (actual)
Nov 3, 2026
Enrollment
798 (estimated)→806 (actual)
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Recruiting→Completed
    Primary completion Dec 31, 2028→Nov 1, 2026 (now actual)
    Study completion Dec 31, 2028→Nov 1, 2026 (now actual)
    Enrollment 798 (estimated)→806 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07294209
Lead sponsor
Southwest Hospital, China
Responsible party
Zhenhua Zhou (Professor, Southwest Hospital, China) — Principal investigator
First posted
Dec 19, 2025
Start date
Dec 19, 2025
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026
Last update
Nov 3, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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