A Phase 2 interventional study of Low dose tenecteplase and High dose tenecteplase in Stroke, sponsored by Huashan Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Huashan Hospital · Phase 2, Interventional, and Treatment
To select the best dosage of tenecteplase for acute ischemic stroke patients (onset time 4.5-24h) of large vessel occlusion using early combined CT/MR imaging outcomes
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 86 is above the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Huashan Hospital is the lead sponsor of 246 studies on the registry; 104 are open to participants now.
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Exclusion Criteria:
Drug: Low dose tenecteplase
Drug: High dose tenecteplase
Intravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg)
Intravenous (IV) tenecteplase 0.32 mg/kg (single bolus; maximum dose 32 mg)
Favourable outcome: patients without endovascular therapy obtained >50% reperfusion at 4-6 hours
Without endovascular therapy: \>50% reperfusion on computed tomography perfusion (CTP) at 4-6 hours
Time frame: 4-6 hours
Favourable outcome: patients with endovascular therapy: mTICI score 2b or better at initial angiogram
With endovascular therapy: mTICI score 2b or better at initial angiogram after thrombolysis before endovascular therapy
Time frame: Before endovascular therapy
Favourable outcome: no symptomatic intracranial hemorrhage at 24-36 hours
No symptomatic intracranial hemorrhage at 24-36 hours
Time frame: 24-36 hours
Imaging efficacy outcome: recanalization rate on CT/magnetic resonance angiography
Recanalization rate on CTA/MRA at 4-6 hours
Time frame: 4-6 hours
Imaging efficacy outcome: Infarct volume growth (ml) at 3-5 days on MRI
Infarct volume growth (ml) at 3-5 days on MRI
Time frame: 3-5 days
Clinical efficacy outcome: major neurological improvement at 24-36 hours ( NIHSS reduction ≥8 or return to 0-1)
Major neurological improvement at 24-36 hours ( NIHSS reduction \>8 or return to 0-1)
Time frame: 24-36 hours
Clinical efficacy outcome: NIHSS change
NIHSS change at 24-36 hours as a continuous variable
Time frame: 24-36 hours
Clinical efficacy outcome: excellent functional outcome (modified Rankin scale 0-1) vs (modified Rankin scale 2-6) at 90 days
Excellent functional outcome (modified Rankin scale 0-1) vs (modified Rankin scale 2-6) at 90 days. The modified Rankin Scale is a simple 7-point assessment that includes reference to both limitations in activity and changes in lifestyle. 0=No symptoms at all; no limitations and no symptoms. 1=No significant disability despite symptoms; able to carry out all usual duties and activities. 2=Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance. 3=Moderate disability; requiring some help, but able to walk without assistance. 4=Moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance. 5=Severe disability: bedridden, incontinent, and requiring constant nursing care and attention. 6=Death.
Time frame: 90 days
Clinical efficacy outcome: good functional outcome (modified Rankin scale 0-2) vs (modified Rankin scale 3-6) at 90 days
Good functional outcome (modified Rankin scale 0-2) vs (modified Rankin scale 3-6) at 90 days. The modified Rankin Scale is a simple 7-point assessment that includes reference to both limitations in activity and changes in lifestyle. 0=No symptoms at all; no limitations and no symptoms. 1=No significant disability despite symptoms; able to carry out all usual duties and activities. 2=Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance. 3=Moderate disability; requiring some help, but able to walk without assistance. 4=Moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance. 5=Severe disability: bedridden, incontinent, and requiring constant nursing care and attention. 6=Death.
Time frame: 90 days
Clinical efficacy outcome: modified Rankin scale shift
Modified Rankin scale shift at 90 days. The modified Rankin Scale is a simple 7-point assessment that includes reference to both limitations in activity and changes in lifestyle. 0=No symptoms at all; no limitations and no symptoms. 1=No significant disability despite symptoms; able to carry out all usual duties and activities. 2=Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance. 3=Moderate disability; requiring some help, but able to walk without assistance. 4=Moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance. 5=Severe disability: bedridden, incontinent, and requiring constant nursing care and attention. 6=Death.
Time frame: 90 days
Imaging safety outcome: Intracranial hemorrhage of any volume at 24-36 hours
Intracranial hemorrhage of any volume at 24-36 hours
Time frame: 24-36 hours
Imaging safety outcome: parenchymal hematoma 2 at 24-36 hours
Parenchymal hematoma 2 at 24-36 hours
Time frame: 24-36 hours
Imaging safety outcome: Symptomatic intracranial hemorrhage at 24-36 hours
Symptomatic intracranial hemorrhage at 24-36 hours
Time frame: 24-36 hours
Clinical safety outcome: Poor functional outcome (mRS 5, 6) at 90 days
Poor functional outcome (mRS 5, 6) at 90 days. The modified Rankin Scale is a simple 7-point assessment that includes reference to both limitations in activity and changes in lifestyle. 0=No symptoms at all; no limitations and no symptoms. 1=No significant disability despite symptoms; able to carry out all usual duties and activities. 2=Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance. 3=Moderate disability; requiring some help, but able to walk without assistance. 4=Moderately severe disability: unable to walk without assistance, and unable to attend to own bodily needs without assistance. 5=Severe disability: bedridden, incontinent, and requiring constant nursing care and attention. 6=Death.
Time frame: 90 days
Clinical safety outcome: Rate of systemic bleeding
Rate of systemic bleeding within 24 hours
Time frame: 24 hours
Barthel index
Barthel index at 90 days. The Barthel Index is a scale that indicates the ability to perform a selection of activities of daily living. It comprises 10 items (tasks), with total scores ranging from 0 (worst mobility in activities of daily living) to 100 (full mobility in activities of daily living) and it has adequate clinimetric (quality of clinical measurements) properties in stroke rehabilitation. In the index, the 10 items have these scoring combinations: a) 0 and 5, b) 0, 5 and 10, or c) 0, 5, 10 and 15. These items in the Barthel Index address a patient's ability in feeding, bathing, grooming, dressing, bowel and bladder control, toileting, chair transfer, ambulation and stair climbing.
Time frame: 90 days
Ran from Dec 2019 to primary completion in Dec 2021, 24 months.
Of 123 non-industry phase 2 interventional studies under Stroke, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 56. This study's 24 months is below that.
Counting every sponsor, half of 153 studies reached it within 36 months; a quarter within 23 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tenecteplase