Dataset Information

Early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT): Study protocol of a multicenter, randomized, double-blind, placebo-controlled clinical trial.

ABSTRACT:

Background

Nearly half of patients with acute ischemic stroke who undergo intravenous thrombolysis (IVT) fail to achieve excellent functional outcomes. Early administration of tirofiban after IVT may improve patient outcomes.

Objective

To evaluate the efficacy and safety of early tirofiban administration after intravenous tenecteplase in patients with acute ischemic stroke.

Methods and design

The ADVENT trial is a multicenter, randomized, parallel-controlled, double-blind clinical trial. A total of 1084 patients undergoing IVT without subsequent endovascular treatment will be recruited from multiple hospitals in China. Subjects will be randomized in a 1:1 ratio to receive tirofiban or placebo, which will be infused within 6 h after IVT until 24 h after IVT, at 0.4 μg/kg/min for 30 min and then at 0.1 μg/kg/min. The primary efficacy outcome is the proportion of patients with excellent functional outcomes (modified Rankin Scale (mRS) ⩽ 1) at 90 days. Secondary outcomes include the proportion of patients with favorable functional outcomes (mRS ⩽ 2) at 90 days and neurological functional assessments evaluated during hospitalization. Symptomatic intracranial hemorrhage will be the primary safety outcome. Mortality and other adverse events will be recorded.

Discussion

This pivotal trial will provide important data on the early administration of antiplatelet therapy after IVT and may promote progress in treatment standards.

Trial registry

ClinicalTrials.gov (NCT06045156).

SUBMITTER: Guo ZN

PROVIDER: S-EPMC11318417 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT): Study protocol of a multicenter, randomized, double-blind, placebo-controlled clinical trial.

Guo Zhen-Ni ZN Zhang Ke-Jia KJ Zhang Peng P Qu Yang Y Abuduxukuer Reziya R Nguyen Thanh N TN Chen Hui-Sheng HS Yang Yi Y

European stroke journal 20240109 2

<h4>Background</h4>Nearly half of patients with acute ischemic stroke who undergo intravenous thrombolysis (IVT) fail to achieve excellent functional outcomes. Early administration of tirofiban after IVT may improve patient outcomes.<h4>Objective</h4>To evaluate the efficacy and safety of early tirofiban administration after intravenous tenecteplase in patients with acute ischemic stroke.<h4>Methods and design</h4>The ADVENT trial is a multicenter, randomized, parallel-controlled, double-blind c ...[more]

PMID: 38196129

Similar Datasets

Project description:ImportanceStroke is a major cause of morbidity and mortality. Timely administration of intravenous thrombolysis (IVT) is essential for improving outcomes for patients with acute ischemic stroke. Significant disparities exist in IVT administration based on socioeconomic and racial and ethnic backgrounds. Understanding how hospital-level segregation is associated with stroke treatment outcomes is crucial for addressing these disparities.ObjectiveTo investigate the association between hospital segregation, using the Index of Concentration at the Extremes (ICE), and IVT administration rates among patients with stroke.Design, setting, and participantsThis retrospective cohort study used US hospital data from the 2016-2020 National Inpatient Sample database. Using International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Clinical Modification codes, patients admitted to hospitals with acute ischemic stroke were included. Statistical analysis was performed from March through July 2024.ExposureHospital segregation measured by the ICE, quantifying socioeconomic and racial and ethnic extremes within hospitals. ICE values range from -1 (predominantly Black and socioeconomically disadvantaged) to 1 (predominantly White and socioeconomically advantaged). Hospitals were categorized into ICE quintiles, with the first quintile representing the most disadvantaged hospitals, the third quintile representing a balanced patient mix, and the fifth quintile representing the most privileged hospitals.Main outcomes and measuresThe primary outcome was IVT administration rates. Secondary outcomes included racial and ethnic disparities in IVT administration across ICE quintiles.ResultsAmong 2 494 945 patients with stroke, the mean (SD) age was 70.1 (14.0) years, 50.2% were male, 0.5% were American Indian, 3.1% were Asian or Pacific Islander, 17.4% were Black, 8.2% were Hispanic, 68.2% were White, and 2.6% were other race or ethnicity. Of these patients, 65.4% were treated at hospitals in the third ICE quintile, while 1.2% of patients were treated at hospitals in the first ICE quintile. Patients at hospitals in the fourth and fifth ICE quintiles were significantly more likely to receive IVT (fourth quintile: adjusted odds ratio [AOR], 1.32 [95% CI, 1.26-1.38]; fifth quintile: AOR, 1.27 [95% CI, 1.21-1.34]) compared with those in the first quintile. Racial and ethnic disparities in IVT administration were most pronounced in the first ICE quintile, where Black patients were 32% less likely than White patients to receive IVT (AOR, 0.68 [95% CI, 0.58-0.79]). This disparity decreased but persisted in higher quintiles.Conclusions and relevanceIn this study of hospital segregation and IVT administration rates, segregation was associated with lower likelihood of IVT administration for patients at hospitals serving predominantly Black and socioeconomically disadvantaged communities. Socioeconomic improvements were associated with reduced, but not eliminated, racial and ethnic disparities in stroke treatment. Addressing structural racism and segregation is crucial for equitable access to stroke care.

Project description:IntroductionThe safety and efficacy of tirofiban in intravenous thrombolysis (IVT) bridging to mechanical thrombectomy in patients with acute ischemic stroke (AIS) is unknown. The purpose of this meta-analysis was to evaluate the safety and efficacy of tirofiban in IVT bridging to mechanical thrombectomy in acute ischemic stroke.MethodsWe systematically searched PubMed, EMBASE, Web of Science, and The Cochrane Library, CNKI, and Wan Fang databases for randomized controlled trials and observational studies (case-control studies and cohort studies) comparing the tirofiban and non-tirofiban groups in AIS intravenous thrombolysis bridging to mechanical thrombectomy (Published by November 20, 2021). Our primary safety endpoints were symptomatic cerebral hemorrhage (sICH), intracranial hemorrhage (ICH), postoperative re-occlusion, and 3-month mortality; the efficacy endpoints were 3-month favorable functional outcome (MRS ≤ 2) and successful recanalization rate (modified thrombolytic therapy in cerebral infarction (mTICI) 2b or 3).ResultsA total of 7 studies with 1,176 patients were included in this meta-analysis. A comprehensive analysis of the included literature showed that the difference between the tirofiban and non-tirofiban groups in terms of successful recanalization (OR = 1.19, 95% Cl [0.69, 2.03], p = 0.53, I 2 = 22%) and favorable functional outcome at 3 months (OR = 1.13, 95% Cl [0.81, 1.60], p = 0.47, I 2 = 17%) in patients with IVT bridging mechanical thrombectomy of AIS was not statistically significant. Also, the differences in the incidence of sICH (OR = 0.97, 95% Cl [0.58, 1.62], p = 0.89) and ICH (OR = 0.83, 95% Cl [0.55, 1.24], p = 0.36) between the two groups were not statistically significant. However, the use of tirofiban during IVT bridging mechanical thrombectomy reduced the rate of postoperative re-occlusion (OR = 0.36, 95% Cl [0.14, 0.91], p = 0.03) and mortality within 3 months (OR = 0.54, 95% Cl [0.33, 0.87], p = 0.01) in patients.ConclusionThe use of tirofiban during IVT bridging mechanical thrombectomy for AIS does not increase the risk of sICH and ICH in patients and reduces the risk of postoperative re-occlusion and mortality in patients within 3 months. However, this result needs to be further confirmed by additional large-sample, multicenter, prospective randomized controlled trials.Systematic review registrationhttp://www.crd.york.ac.uk/PROSPERO/, identifier: CRD42022297441.

Dataset Information

Early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT): Study protocol of a multicenter, randomized, double-blind, placebo-controlled clinical trial.

Background

Objective

Methods and design

Discussion

Trial registry

Publications

Early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT): Study protocol of a multicenter, randomized, double-blind, placebo-controlled clinical trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets