Ischemic Stroke
Conditions
Brief summary
After intravenous thrombolysis, the overall recanalization rate is 46%, and recclusion after initial recanalization occurs in 14-34%. In the MR TEA, the investigators compared the effects of administration of tirofiban in acute ischemic stroke patients treated with intravenous alteplase thrombolysis with alteplase alone.
Interventions
DRUGTirofiban
Tirofiban Injection after the alteplase intravenous thrombolysis
DRUGAlteplase
Only alteplase intravenous thrombolysis
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of favorable outcome | 90 days | favorable outcome was defined as a score of 0, or 1 on the modified Rankin scale |
Secondary
| Measure | Time frame |
|---|---|
| NIHSS score | 7 days |
| Deterioration after improvement | 24 hours |
| Final infarct size | 24 hours |
| mRS ≤2 | 90 days |
Other
| Measure | Time frame |
|---|---|
| Symptomatic intracranial hemorrhage | 7 days or discharge |
| Severe systemic bleeding | 7 days or discharge |
| Stroke-related death | 90 days |
| Death form any cause | 90 days |
Countries
China
Outcome results
None listed