2025-07-20
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Eligibility, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-07-02→confirmed 2025-07-09
Eligibility criteria+1 characters
[...] me defined as "last known well" time;
Clinical diagnosis of mildminor ischemic stroke (NIHSS ≤ 5) with persistent unilateral limb [...]
Study description+238 characters
TheThis study will beis a multicenter, prospective, randomized, double-blind, doubl [...] ith acute minor ischemic stroke (baseline NIHSS≤5) within 4.5hours5 hours of symptoms onset (symptom onset is defined by the "last seen normal" principle for wake-up stroke) will be enrolled.
TheEligible measurablepatients must have neurological deficitdeficits isinvolving definedat as impairment ofleast language or motor function.
Participants will be randomized [...] not exceed 25mg, plus placebo oral aspirin and clopidogrel.
Aspirin 100mg and clopidogrel 300mg will be given within 6 ± 2 hours after thrombolytic ther [...] [...]
Study sitesdetails revised at 1 of 1 site
2025-07-03
notable
Recruiting→Not Yet Recruiting Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v2
Trial statusRecruiting→Not Yet Recruiting
Primary completion date2025-07-31→2026-07-31
Completion date2025-12-31→2026-10-31
Start date2024-08-26→2025-07-02
Enrollment target1394→1386
InterventionsControl group (Drug), rhTNK-tPA (Drug)→Control group (Aspirin combined with clopidogrel) (Drug), rhTNK-tPA (Drug)
Eligibility criteria-629 characters
Inclusion Criteria
Age ≥ 18 years;
CanOnset-to-treatment betime treated< with4.5 study drug within 12 hours of symptoms onset*(*Symptomh; onset istime defined by theas "last seenknown normalwell" principle)time;
Clinical diagnosis of minormild ischemic stroke (baselineNIHSS NIHSS≤ 5) with apersistent measurableunilateral neurologicallimb deficitweakness or speech symptoms, defined as impairmenta score of ≥1 on either the language item or motora functionsingle limb item of the NIHSS;
DWI/FLAIR mismatch on magnetic resonance imaging.
Pre-stroke mRS 0-1;
Informed consent signed.
Exclusion Criteri [...] [...]
Secondary endpoints11 to 16 entries
Ordinal distribution of mRS scoresscore at 90-day (± 7 days)
COSMOS Scale 0-1 at 90-day (±7days)
COSMOS scale at 90-day (±7 days)
NIHSS 0-1 at 24-hour, 7-day or before discharge (analyze which occurs first) or/ neurological improvement (NIHSS decreased≥24 from baseline)
Neurological deterioration at 90 days
European quality of life visual analogue scale at 90 days
Symptomatic intracranial hemorrhage according to the ECASSIII criteria atwithin 36-hour, 7-day or discharge (analyze which occurs first).
Symptomatic intracranial hemorrhage according to the ECASSIII criteria atwithin 7 days or befor [...] [...]
Study description+1 characters
The study will be a multicenter, prospective, open-labelrandomized, blindeddouble-endpointblind, randomizeddouble-dummy controlled trial (2 arms with 1:1 randomization) trial.
Participants with acute minor ischemic stroke (baseline NIHSS≤5) within 12 hours4.5hours of symptoms onset (symptom onset is defined by the "last seen normal" principle for wake-up stroke) accompanied with measurable neurological deficit and DWI/FLAIR mismatch will be enrolled.
The measurable neurological deficit is def [...] rhTNK-tPA): 0.25mg/kg, the maximum dose does not exceed 25mg, plus placebo oral aspirin and clopidogrel [...]
Study sitesdetails revised at 1 of 1 site
Study title-9 characters
Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ(TRACE Ⅳ)
2024-08-25
minor
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v1
Start date2024-05-20→2024-08-26
Enrollment target1874→1394
InterventionsSingle/dual antiplatelet therapy (Drug), rhTNK-tPA (Drug)→Control group (Drug), rhTNK-tPA (Drug)
Eligibility criteria+70 characters
Inclusion Criteria
Age ≥ 18 years;
Can be treated with study drug within 4.512 hours of symptoms onset*(*Symptom onset is defined by the " [...] eficit defined as impairment of language or motor function;
DWI/FLAIR mismatch on magnetic resonance imaging.
Pre-stroke mRS 0-1;
Informed consent signed.
Exclusion Criteria
Contradictory or unable to complete MRI examination.
Planned or likely to receive acute endovascular treatments (any angioplasty or vascular [...] h a known bleeding diathesis or with a platelet count < 100×10^9109/L;
Participants with a systolic blood pressure ≥> 180 or a diastolic blood pres [...] [...]
Secondary endpoints12 to 11 entries
Neurological impairment (NIHSS increased≥4 from baseline) at 90-day (± 7 days)
Study description-54 characters
[...] with acute minor ischemic stroke (baseline NIHSS≤5) within 4.512 hours of symptoms onset (symptom onset is defined by the "l [...] up stroke) accompanied with measurable neurological deficit and DWI/FLAIR mismatch will be enrolled.
The measurable neurological deficit is def [...] 5mg/kg, the maximum dose does not exceed 25mg.
Control group: (standardStandard medical care): Single/dual antiplatelet therapy (aspirin, clopidogrel, ticagrelor, etc.) according to the guideline.
The primary endpoint is excelle [...]