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Clinical Trials in China / NCT07294209
Recruiting Phase 4

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

NCT07294209 · tracked via the Priya Life Science China tracker
Sponsor
Southwest Hospital, China
Phase
Phase 4
Started
2025-12-19
Last updated
2026-06-23

Condition(s) studied

Acute Ischemic Stroke Patients

Investigational drug(s) / intervention(s)

low-dose tenecteplase intravenous thrombolysisstandard-dose tenecteplase intravenous thrombolysis

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.

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.

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.

Eligibility

Sex
ALL
Min age
70 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (51)

FacilityCityRegionStatus
Southwest Hospital, Chongqing, China Chongqing Chongqing Municipality Recruiting
Wuchang People's Hospital Harbin Heilongjiang Recruiting
Shenqiu County People's Hospital Zhoukou Henan Recruiting
Anshan Changda Hospital Anshan China Not Yet Recruiting
Anyang People's Hospital Anyang China Recruiting
Huaxian People's Hospital of Henan Anyang China Recruiting
Baoshan People's Hospital Baoshan China Not Yet Recruiting
People's Hospital of Zhijin County Bijie China Not Yet Recruiting
Bishan Hospital Chongqing China Not Yet Recruiting
Chongqing Emergency Medical Center Chongqing China Recruiting
Chongqing University Fuling Hospital Chongqing China Recruiting
Chongqing University Jiangjin Hospital Chongqing China Recruiting
Chongqing University Three Gorges Hospital Chongqing China Not Yet Recruiting
Dianjiang People's Hospital OF Chongqing Chongqing China Recruiting
People's Hospital Of Xiushan County Chongqing China Not Yet Recruiting
The People's Hospital of Dazu Chongqing Chongqing China Not Yet Recruiting
The People's Hospital of HeChuan, Chongqing Chongqing China Recruiting
The People's Hospital of Rongchang Chongqing Chongqing China Recruiting
The People's Hospital of Tongnan District Chongqing City Chongqing China Recruiting
The Seventh People's Hospital of Chongqing Chongqing China Recruiting
Tongliang Hospital Chongqing China Recruiting
Yunyang County People's Hospital Chongqing China Recruiting
Dali Bai Autonomous Prefecture People's Hospital Dali China Not Yet Recruiting
Dazhou Central Hospital Dazhou China Recruiting
The People's Hospital of Zhongjiang Deyang China Not Yet Recruiting
Guang an People's Hospital Guang’an China Not Yet Recruiting
Guizhou Provincial People's Hospital Guiyang China Not Yet Recruiting
The Second People's Hospital of Guiyang(Guiyang Jinyang Hospital) Guiyang China Recruiting
The First Affiliated Hospital of Harbin Medical University Ha’erbin China Not Yet Recruiting
Xunxian People's Hospital Hebi China Recruiting
Heyuan People's Hospital Heyuan China Not Yet Recruiting
Qichun People's Hosiptal Huanggang China Recruiting
The People's Hospital Of Jianyang City Jianyang China Not Yet Recruiting
Laixi People's Hospital Laixi China Not Yet Recruiting
Leshan Geriatric Specialized Hospital Leshan China Recruiting
People's Hospital of Leshan Leshan China Not Yet Recruiting
Luoyang Mengjin People's Hospital Luoyang China Recruiting
Nanbu People's Hospital Nanchong China Recruiting
Puyang People's Hospital Pujiang China Not Yet Recruiting
The People's Hospital of Nan Le Xian Pujiang China Recruiting

+ 11 more sites — see the full list on the official registry below.

More Southwest Hospital, China trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07294209 on ClinicalTrials.gov ↗ ← All trials in China