Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT03357133
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18
* Ischemic stroke symptom with onset ≤4.5 hours treated with IV rt-PA according with local guidelines.
* 6≤ NIHSS ≤20 before IV tPA, or NIHSS \>20 but decrease ≥ 8 after IV rt-PA.
* ≥ 4 point total NIHSS or ≥ 2 point in one NIHSS category during and after the IV rt-PA compared to immediately before worsening, an emergency CT scan should be performed to exclude intracranial hemorrhage
* Patients or their legally acceptable representative agreed to the treatment and signed the informed consent form
Exclusion Criteria:
* Patients whom the treating physician is planning to treat with mechanical thrombectomy or other endovascular procedure (e.g. Intra-arterial thrombolysis) according with local guidelines.
* Patients had used antiplatelet therapy in the past 5 days before the stroke.
* Patients had used anticoagulant therapy in the past 5 days before the stroke.
* Scheduled for surgery or interventional treatment requiring study drug cessation.
* CT scan finding of hypoattenuation involving ≥1/3 of the MCA territory.
* Any evidence of clinically significant bleeding ,or known coagulopathy.
* Renal insufficiency (creatinine clearance rate \<30ml/min)
* Hepatic dysfunction (ALT \>2 folds of Upper limit of normal value or AST\>2 folds of Upper limit of normal value).
* Pre-existing disability with ≥ mRS 2.
* Known allergic to tirofiban or other glycoprotein IIb/IIIa antagonist.
* Severe non-cerebrovascular disease with life expectancy \<3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03357133
Study Brief:
Protocol Section:
NCT03357133