Phase
Condition
Stroke
Occlusions
Thrombosis
Treatment
Control group
Single/dual antiplatelet therapy
rhTNK-tPA
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
Age ≥ 18 years;
Can be treated with study drug within 12 hours of symptoms onset*(*Symptom onset is defined by the "last seen normal" principle);
Clinical diagnosis of minor ischemic stroke (baseline NIHSS≤5) with a measurable neurological deficit 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 acute endovascular treatments (any angioplasty or vascular surgery);
NIHSS 1a > 2;
Known allergic to rhTNK-tPA;
Known history of intracranial hemorrhage;
Clinical stroke or serious head/spinal trauma within 3 months;
Intracranial or spinal surgery within 3 months;
Known history of gastrointestinal or urinary tract hemorrhage in the previous 21 days.
Participants with a history of major surgery in the previous 14 days;
Arterial puncture at a non-compressible site in the previous 7 days.
Participants with intracranial tumors (excluding neuroectoderm origin, such as meningioma), huge intracranial aneurysm, or arterio-venous malformation.
Intracranial hemorrhage (including cerebral parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/epidural hematoma)
Participants with active visceral bleeding;
Participants with aortic arch dissection;
Participants with a known bleeding diathesis or with a platelet count < 100×109/L;
Participants with a systolic blood pressure > 180 or a diastolic blood pressure > 100 mmHg after repeated measurements and aggressive treatments;
Blood glucose < 2.8 or > 22.2 mmol / L);
Clear indication for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis);
Receive intravenous thrombolysis within 24 hours;
Receive direct oral anticoagulant therapy with international normalized ratio (INR) > 1.7s or PT > 15 s;
Receive low molecular weight heparin or heparinoid within 24 hours;
Receive thrombin inhibitors or factor Xa inhibitors within 48 hours;
Receive GP2b3a inhibitors within 72 hours;
Participants who have large areas (greater than one third of middle cerebral artery territory) of obvious low density on the baseline CT scan;
Participants with a seizure at onset thought to be presenting with postictal paralysis (Todd's paralysis) mimicking stroke.
Participants with severe infection, such as bacterial endocarditis, pericarditis, acute pancreatitis;
Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control;
Participation in another clinical study with an experimental product in the previous 3 months;
Participants deemed unsuitable for participation in this trial by the investigator or those for whom participation in this trial may result in greater risks.
Study Design
Study Description
Connect with a study center
Beijing Tiantan Hospital
Beijing, Beijing
ChinaActive - Recruiting
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