Efficacy of Intravenous Tissue-type Plasminogen Activator on Acute Ischemic Stroke Patients With Large Vessel Occlusions

• Conditions: Stroke, Ischemic; Stroke, Acute

• Registration Number: NCT04170647
• Lead Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

Brief Summary

This is an observational prospective study about the reperfusion rate of intravenous thrombolysis on ischemic stroke patients with large vessel occlusions and predictor factors of successful recanalization.

Detailed Description

Stroke is one the most common cause of mortality and disabilities in the world, with the highest incidence in East Asia. Current American Stroke Association (ASA) and European Stroke Organisation (ESO) guidelines recommend bridging therapy with IVT for all eligible patients before indicating endovascular thrombectomy (EVT) for those with large vessel occlusions (LVO). Nevertheless, the decision to use IVT on stroke patients with LVO is still debatable, with many arguments against and supporting combined therapy or direct mechanical thrombectomy. At present, guideline in our hospital advocates the use of IVT in all patients who meet eligibility criteria and present within the 4,5 hour window for anterior circulation stroke and within 24 hour window for posterior circulation stroke. Due to the overcrowded nature of our center as a high-end specialization establishment in Vietnam, it is noted that our door-to-groin time is sub-optimal. This fact inadvertently prolongs the time of action of intravenous tissue-type plasminogen activator before the re-assessment of occlusion site on interventional radiography. Therefore, it is possible for us to better estimate the reperfusion effectiveness of IVT as well as analyse other factors that might have an influence on this rate. The goal of our study is to determine the recanalization rate of IVT and related predictor factors in AIS patients.

Study Timeline

• Study Start: 2017-10-01
• Status Verified: 2019-11
• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-18
• Last Update Submitted: 2019-11-18
• Study First Posted: 2019-11-20
• Last Update Posted: 2019-11-20
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

1. Age 18 and older with consent form signed.
2. Patients hospitalized in 115 People's Hospital for acute ischemic stroke.
3. Patients receiving full dose of IVT, with a confirmed LVO (including MCA M1, MCA M2, ICA, BA and VA) on angiography and repeat vascular imaging within 24 hours of hospitalization.

Exclusion Criteria

1. Patients with evidence of chronic occlusion of large vessels.
2. Patients without source angiography data to assess the characteristics of thrombus

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
reperfusion rate	within 24 hours of hospitalization	the reperfusion rate of intravenous thrombolysis in acute ischemic stroke with large vessel occlusion first confirmed by angiography and assessed later by a vascular imaging modality.

Secondary Outcome Measures

Name	Time	Method
symptomatic intracerebral hemorrhage	48 hours after initiation of IVT	incidence of symptomatic intracerebral hemorrhage 48 hours after initiation of IVT

Trial Locations

Locations (1)

115 People's Hospital; 🇻🇳 Ho Chi Minh City, Vietnam