Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ
ConditionMinor Ischemic Stroke
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital
About this trial
The purpose of this study is to evaluate the efficacy and safety of intravenous tenecteplase (0.25 mg/kg) compared with standard therapy in patients with acute ischemic stroke presenting with mild symptoms-defined as a National Institutes of Health Stroke Scale (NIHSS) score ≤5 accompanied by persistent unilateral limb weakness or speech impairment within 4.5 hours of onset.
Eligibility criteria
Qualifiers
Age ≥ 18 years;
Onset-to-treatment time < 4.5 h; onset time defined as "last known well" time;
Clinical diagnosis of minor ischemic stroke (NIHSS ≤ 5) with persistent unilateral limb weakness or speech symptoms, defined as a score of ≥1 on either the language item or a single limb item of the NIHSS;
Pre-stroke mRS 0-1;
Disqualifiers
Planned or likely acute endovascular treatments before randomization;
NIHSS 1a > 2;
Known allergic to rhTNK-tPA;
History of intracranial hemorrhage;
Trial design
Treatments tested in this trial
- rhTNK-tPA
- Control group (Aspirin combined with clopidogrel)
Treatment groups
1,386 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov