Phase
Condition
Cerebral Ischemia
Cardiac Ischemia
Stroke
Treatment
Control group (Aspirin combined with clopidogrel)
Control group
Single/dual antiplatelet therapy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
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;
Informed consent signed.
Exclusion Criteria
Planned or likely acute endovascular treatments before randomization;
NIHSS 1a > 2;
Known allergic to rhTNK-tPA;
History of intracranial hemorrhage;
Severe head trauma or previous stroke within 3 months;
Intracranial or spinal surgery within 3 months;
Gastrointestinal or urinary tract hemorrhage within 3 weeks;
Major surgery within 2 weeks;
Arterial puncture at a non-compressible site within 1 week;
Intracranial tumors (excluding neuroectodermal tumors, e.g., meningiomas), large intracranial aneurysms, or arteriovenous malformations;
Intracranial hemorrhage, including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/epidural hematoma;
Active visceral bleeding;
Concomitantaortic arch dissection;
Acute bleeding tendency, including platelet count <100×10⁹/L or other clinically significant conditions;
Uncontrolled hypertension after active antihypertensive treatment: systolic blood pressure >180 mm Hg or diastolic >100 mm Hg;
Blood glucose < 2.8 or > 22.2 mmol / L;
Prior anticoagulant therapy, such as oral warfarin, with an INR >1.7 or PT >15 seconds;
Use of heparin within 24 hours;
Use of thrombin inhibitors or factor Xa inhibitors within 48 hours;
Large cerebral infarction on head CT or MRI (infarction area >1/3 of the middle cerebral artery territory);
Todd's paralysis after a seizure or other neurological/psychiatric disorders affecting cooperation;
Severe, uncontrolled infections (e.g., acute pericarditis, infective endocarditis, or acute pancreatitis);
Pregnant or breastfeeding women, or women unwilling to use effective contraception during the study period;
Participation in another clinical trial within 3 months prior to screening;
Other severe illnesses with a life expectancy of less than six months;
Deemed unsuitable for the study or at increased risk by the investigator's judgment.
Study Design
Study Description
Connect with a study center
Beijing Tiantan Hospital
Beijing, Beijing
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.