Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tirofiban, Tirofiban simulant.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
Overview
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
- Drug Tirofiban
Tirofiban is a selective glycoproteinⅡb/Ⅲa receptor inhibitor, which inhibits platelet aggregation and thrombi formation - Drug Tirofiban simulant
Tirofiban simulant is placebo packed the same style as tirofiban
Primary outcome measures
- Proportion of patients of modified Rankin Scale (mRS)≤1 [Time frame: 90±7 days]
Secondary outcome measures (3)
- Proportion of patients of mRS≤2 [Time frame: 90±7 days]
- Distribution of mRS [Time frame: 90±7 days]
- National Institute of Health stroke scale (NIHSS) [Time frame: 24 hours after IVT, 7 days]
Eligibility criteria
Inclusion criteria
- Age≥18 years old;
- Clinically diagnosed as acute ischemic stroke and received standard dose (0.25mg/kg) of tenecteplase IVT within 4.5 hours of onset;
- Total National Institute of Health stroke scale (NIHSS)≥4 or single limb motor item score≥2, and total NIHSS≤15 after IVT;
- Tirofiban or placebo treatment can be initiated within 6h after IVT;
- mRS score before onset≤ 1;
- Intracranial hemorrhage is ruled out by CT head after IVT;
Exclusion criteria
- Received or plan to undergo bridge therapy;
- Large area of infarct indicated by radiological imaging(≥1/3 of middle cerebral artery supply area);
- Atrial fibrillation or suspected cardiac embolism;
- Accompanied by epileptic seizures;
- Using antiplatelet, anticoagulant or fibrinolytic agents within 24h before recruitment;
- Active bleeding or tendency to bleed after receipt of intravenous thrombolysis;
- Digestive system bleeding, urinary system bleeding, hemorrhagic retinopathy or other systemic bleeding events within 1 year;
- 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；
- Life expectancy less than 3 months;
- Pregnant or lactating women;
- Known allergy to tirofiban;
- Being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.;
- Patients who are unwilling to be followed up or likely to have poor treatment compliance;
- Other situations that the researcher deems unsuitable for inclusion in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The first hospital of Jilin University — Changchun
Publications
- Guo ZN, Zhang KJ, Zhang P, Qu Y, Abuduxukuer R, Nguyen TN, Chen HS, Yang Y. Early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT): Study protocol of a multicenter, randomized, double-blind, placebo-controlled clinical trial. Eur Stroke J. 2024 Jun;9(2):510-514. doi: 10.1177/23969873231225069. Epub 2024 Jan 9. PMID 38196129
Identifiers
NCT: NCT06045156 · ADVENT