Actively Recruiting

Phase 4
Age: 70Years +
All Genders
NCT07294209

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

Led by Southwest Hospital, China · Updated on 2026-04-23

798

Participants Needed

49

Research Sites

158 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 70Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 70 years or older
  • Diagnosis of ischemic stroke with measurable neurological deficit (NIHSS 1 to 25); if NIHSS less than 4, must have measurable motor power deficit of at least 1 in upper or lower limbs
  • Stroke symptoms present for at least 30 minutes without significant improvement before randomization
  • Able to start thrombolytic therapy within 4.5 hours of stroke onset
  • Premorbid modified Rankin Scale score of 0 or 1
  • Informed consent provided by patient or surrogate
Not Eligible

You will not qualify if you...

  • Imaging shows multi-lobar infarction affecting more than one-third of a cerebral hemisphere
  • Acute bleeding disorders or allergy to tenecteplase, including:
    • Known genetic bleeding predisposition or recent significant bleeding within 6 months
    • Heparin use within 48 hours with prolonged aPTT
    • Use of vitamin K antagonists or novel oral anticoagulants with abnormal coagulation tests
    • Platelet count below 100 x 10^9/L
    • History of central nervous system damage or surgery
    • Recent traumatic heart massage or non-compressive blood vessel puncture within 10 days
    • Known or suspected intracranial hemorrhage or subarachnoid hemorrhage
    • Neoplasm with increased bleeding risk
    • Recent ulcerative gastrointestinal disease, esophageal varices, arterial aneurysms, or vascular malformations
    • Significant trauma or major surgery within the past 3 months
    • Any disorder with a significant bleeding risk
  • Presence of intracranial hemorrhage
  • Blood glucose below 2.8 mmol/L or above 22.22 mmol/L
  • Uncontrolled hypertension after treatment (systolic ≥180 mmHg or diastolic ≥100 mmHg)
  • Seizure at stroke onset
  • Concurrent malignancy or severe systemic disease with expected survival under 90 days
  • Participation in other clinical trials within 3 months prior to screening
  • Investigator judgment deeming unsuitability for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 49 locations

1

Southwest Hospital, Chongqing, China

Chongqing, Chongqing Municipality, China, 400038

Actively Recruiting

2

Anshan Changda Hospital

Anshan, China

Not Yet Recruiting

3

Anyang People's Hospital

Anyang, China

Actively Recruiting

4

Huaxian People's Hospital of Henan

Anyang, China

Actively Recruiting

5

Baoshan People's Hospital

Baoshan, China

Not Yet Recruiting

6

People's Hospital of Zhijin County

Bijie, China

Not Yet Recruiting

7

Bishan Hospital

Chongqing, China

Not Yet Recruiting

8

Chongqing Emergency Medical Center

Chongqing, China

Actively Recruiting

9

Chongqing University Fuling Hospital

Chongqing, China

Actively Recruiting

10

Chongqing University Jiangjin Hospital

Chongqing, China

Actively Recruiting

11

Chongqing University Three Gorges Hospital

Chongqing, China

Not Yet Recruiting

12

Dianjiang People's Hospital OF Chongqing

Chongqing, China

Not Yet Recruiting

13

People's Hospital Of Xiushan County

Chongqing, China

Not Yet Recruiting

14

The People's Hospital of Dazu Chongqing

Chongqing, China

Not Yet Recruiting

15

The People's Hospital of HeChuan, Chongqing

Chongqing, China

Actively Recruiting

16

The People's Hospital of Rongchang Chongqing

Chongqing, China

Actively Recruiting

17

The People's Hospital of Tongnan District Chongqing City

Chongqing, China

Actively Recruiting

18

The Seventh People's Hospital of Chongqing

Chongqing, China

Actively Recruiting

19

Tongliang Hospital

Chongqing, China

Actively Recruiting

20

Yunyang County People's Hospital

Chongqing, China

Actively Recruiting

21

Dali Bai Autonomous Prefecture People's Hospital

Dali, China

Not Yet Recruiting

22

Dazhou Central Hospital

Dazhou, China

Not Yet Recruiting

23

The People's Hospital of Zhongjiang

Deyang, China

Not Yet Recruiting

24

Guang an People's Hospital

Guang’an, China

Not Yet Recruiting

25

Guizhou Provincial People's Hospital

Guiyang, China

Not Yet Recruiting

26

The Second People's Hospital of Guiyang(Guiyang Jinyang Hospital)

Guiyang, China

Not Yet Recruiting

27

The First Affiliated Hospital of Harbin Medical University

Ha’erbin, China

Not Yet Recruiting

28

Xunxian People's Hospital

Hebi, China

Actively Recruiting

29

Heyuan People's Hospital

Heyuan, China

Not Yet Recruiting

30

Qichun People's Hosiptal

Huanggang, China

Actively Recruiting

31

The People's Hospital Of Jianyang City

Jianyang, China

Not Yet Recruiting

32

Laixi People's Hospital

Laixi, China

Not Yet Recruiting

33

Leshan Geriatric Specialized Hospital

Leshan, China

Actively Recruiting

34

People's Hospital of Leshan

Leshan, China

Not Yet Recruiting

35

Luoyang Mengjin People's Hospital

Luoyang, China

Actively Recruiting

36

Nanbu People's Hospital

Nanchong, China

Actively Recruiting

37

Puyang People's Hospital

Pujiang, China

Not Yet Recruiting

38

The People's Hospital of Nan Le Xian

Pujiang, China

Actively Recruiting

39

People's Hospital of Ningling County

Shangqiu, China

Actively Recruiting

40

The First People's Hospital of Shangqiu

Shangqiu, China

Actively Recruiting

41

The First People ' S Hospital of Shao Yang

Shaoyang, China

Actively Recruiting

42

The People's Hospital of Gaocheng

Shijiazhuang, China

Actively Recruiting

43

Wuhan Puren Hospital

Wuhan, China

Actively Recruiting

44

Xiangyang NO.1 People's Hospital

Xiangyang, China

Actively Recruiting

45

The second people's hospital of Yibin

Yibin, China

Actively Recruiting

46

Zhumadian Central Hospital

Zhumadian, China

Actively Recruiting

47

Zhuzhou Central Hospital

Zhuzhou, China

Not Yet Recruiting

48

Zigong Third People's Hospital

Zigong, China

Actively Recruiting

49

Ziyang Central Hospital

Ziyang, China

Not Yet Recruiting

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Research Team

H

Hou Xianhua

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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