Could a lower dose of stroke drug be safer for seniors?
NCT ID NCT07294209
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing whether a lower dose of the clot-busting drug tenecteplase is safer and just as effective as the standard dose for treating acute ischemic stroke in people aged 70 and older. About 798 participants will receive either a low dose (0.175 mg/kg) or the standard dose (0.25 mg/kg) within 4.5 hours of stroke symptoms starting. The goal is to see if the lower dose reduces disability and bleeding risks while still improving recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tenecteplase (a clot-busting drug given intravenously)
- What this could lead to
- If successful, this could show that a lower dose of tenecteplase is safer for elderly stroke patients while still being effective, potentially reducing bleeding risks.
- What could go wrong
- This is a Phase 4 trial, but it focuses on a specific age group and a lower dose, so results may not apply to all stroke patients. There is still a risk of bleeding or that the lower dose may be less effective.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 798 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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70 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
51 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Anshan Changda Hospital
NOT_YET_RECRUITINGAnshan, China
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Anyang People's Hospital
RECRUITINGAnyang, China
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Baoshan People's Hospital
NOT_YET_RECRUITINGBaoshan, China
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Bishan Hospital
NOT_YET_RECRUITINGChongqing, China
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Chongqing Emergency Medical Center
RECRUITINGChongqing, China
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Chongqing University Fuling Hospital
RECRUITINGChongqing, China
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Chongqing University Jiangjin Hospital
RECRUITINGChongqing, China
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Chongqing University Three Gorges Hospital
NOT_YET_RECRUITINGChongqing, China
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Dali Bai Autonomous Prefecture People's Hospital
NOT_YET_RECRUITINGDali, China
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Dazhou Central Hospital
RECRUITINGDazhou, China
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Dianjiang People's Hospital OF Chongqing
RECRUITINGChongqing, China
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Guang an People's Hospital
NOT_YET_RECRUITINGGuang’an, China
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Guizhou Provincial People's Hospital
NOT_YET_RECRUITINGGuiyang, China
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Heyuan People's Hospital
NOT_YET_RECRUITINGHeyuan, China
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Huaxian People's Hospital of Henan
RECRUITINGAnyang, China
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Laixi People's Hospital
NOT_YET_RECRUITINGLaixi, China
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Leshan Geriatric Specialized Hospital
RECRUITINGLeshan, China
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Luoyang Mengjin People's Hospital
RECRUITINGLuoyang, China
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Nanbu People's Hospital
RECRUITINGNanchong, China
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People's Hospital Of Xiushan County
NOT_YET_RECRUITINGChongqing, China
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People's Hospital of Leshan
NOT_YET_RECRUITINGLeshan, China
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People's Hospital of Ningling County
RECRUITINGShangqiu, China
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People's Hospital of Zhijin County
NOT_YET_RECRUITINGBijie, China
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Puyang People's Hospital
NOT_YET_RECRUITINGPujiang, China
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Qichun People's Hosiptal
RECRUITINGHuanggang, China
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Shenqiu County People's Hospital
RECRUITINGZhoukou, Henan, 466300, China
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Southwest Hospital, Chongqing, China
RECRUITINGChongqing, Chongqing Municipality, 400038, China
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The First Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITINGHa’erbin, China
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The First People ' S Hospital of Shao Yang
RECRUITINGShaoyang, China
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The First People's Hospital of Shangqiu
RECRUITINGShangqiu, China
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The People's Hospital Of Jianyang City
NOT_YET_RECRUITINGJianyang, China
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The People's Hospital of Dazu Chongqing
NOT_YET_RECRUITINGChongqing, China
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The People's Hospital of Gaocheng
RECRUITINGShijiazhuang, China
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The People's Hospital of HeChuan, Chongqing
RECRUITINGChongqing, China
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The People's Hospital of Nan Le Xian
RECRUITINGPujiang, China
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The People's Hospital of Rongchang Chongqing
RECRUITINGChongqing, China
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The People's Hospital of Tongnan District Chongqing City
RECRUITINGChongqing, China
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The People's Hospital of Zhongjiang
NOT_YET_RECRUITINGDeyang, China
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The Second People's Hospital of Guiyang（Guiyang Jinyang Hospital）
RECRUITINGGuiyang, China
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The Seventh People's Hospital of Chongqing
RECRUITINGChongqing, China
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The second people's hospital of Yibin
RECRUITINGYibin, China
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Tongliang Hospital
RECRUITINGChongqing, China
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Wuchang People's Hospital
RECRUITINGHarbin, Heilongjiang, 150200, China
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Wuhan Puren Hospital
RECRUITINGWuhan, China
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Xiangyang NO.1 People's Hospital
RECRUITINGXiangyang, China
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Xunxian People's Hospital
RECRUITINGHebi, China
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Yunyang County People's Hospital
RECRUITINGChongqing, China
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Zhumadian Central Hospital
RECRUITINGZhumadian, China
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Zhuzhou Central Hospital
NOT_YET_RECRUITINGZhuzhou, China
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Zigong Third People's Hospital
RECRUITINGZigong, China
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Ziyang Central Hospital
NOT_YET_RECRUITINGZiyang, China
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