Acute Ischemic Stroke
Conditions
Keywords
acute ischemic stroke, intravenous thrombolysis, tirofiban
Brief summary
The purpose of this study is to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT
Detailed description
Nearly half of acute ischemic stroke patients underwent intravenous thrombolysis (IVT) failed to achieve excellent functional outcome. Some studies reported that early administrated tirofiban, a selective glycoproteinⅡb/Ⅲa receptor inhibitor, may greatly improve the outcome of patients who received IVT, however they only recruited small sample size. Thus, the investigators design early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT) trial, aiming to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT.
Interventions
DRUGTirofiban
Tirofiban is a selective glycoproteinⅡb/Ⅲa receptor inhibitor, which inhibits platelet aggregation and thrombi formation
DRUGTirofiban simulant
Tirofiban simulant is placebo packed the same style as tirofiban
Sponsors
The First Hospital of Jilin 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
1. Age≥18 years old; 2. Clinically diagnosed as acute ischemic stroke and received standard dose (0.25mg/kg) of tenecteplase IVT within 4.5 hours of onset; 3. Total National Institute of Health stroke scale (NIHSS)≥4 or single limb motor item score≥2, and total NIHSS≤15 after IVT; 4. Tirofiban or placebo treatment can be initiated within 6h after IVT; 5. mRS score before onset≤ 1; 6. Intracranial hemorrhage is ruled out by CT head after IVT;
Exclusion criteria
1. Received or plan to undergo bridge therapy; 2. Large area of infarct indicated by radiological imaging(≥1/3 of middle cerebral artery supply area); 3. Atrial fibrillation or suspected cardiac embolism; 4. Accompanied by epileptic seizures; 5. Using antiplatelet, anticoagulant or fibrinolytic agents within 24h before recruitment; 6. Active bleeding or tendency to bleed after receipt of intravenous thrombolysis; 7. Digestive system bleeding, urinary system bleeding, hemorrhagic retinopathy or other systemic bleeding events within 1 year; 8. Severe renal or liver insufficiency; ALT or AST\>3 times of the upper limit of normal value or above; creatinine clearance rate\<30 mL/min, creatinine\>200μmol/L； 9. Life expectancy less than 3 months; 10. Pregnant or lactating women; 11. Known allergy to tirofiban; 12. Being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.; 13. Patients who are unwilling to be followed up or likely to have poor treatment compliance; 14. Other situations that the researcher deems unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients of modified Rankin Scale (mRS)≤1 | 90±7 days | mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-1 represents excellent functional outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients of mRS≤2 | 90±7 days | mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-2 represents favorable functional outcome |
| Distribution of mRS | 90±7 days | mRS depicts functional outcome of stroke, which ranges from 0-6 |
| National Institute of Health stroke scale (NIHSS) | 24 hours after IVT, 7 days | National Institute of Health stroke scale (NIHSS) ranges from 0 to 42, a low value represents a better outcome |
Other
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic intracranial hemorrhage | within 24 hours of completion of study drug infusion, hospitalization | Symptomatic intracranial hemorrhage is defined according to the ECASS Classification |
| Hemorrhagic transformation | 24 hours after IVT, hospitalization | defined according to the ECASS Classification |
Countries
China
Outcome results
None listed