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

Overview

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.

Full Title of Study: “Reperfusion Rates of Intravenous Tissue-type Plasminogen Activator on Acute Ischemic Stroke Patients With Large Vessel Occlusions and Predictor Factors of Recanalization”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 1, 2020

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.

Interventions

  • Drug: Plasminogen Activators
    • standard dosage of 0.9 mg/kg or reduced dosage of 0.6 mg/kg, divided into a 15% bolus and an 85% venous infusion

Clinical Trial Outcome Measures

Primary Measures

  • reperfusion rate
    • Time Frame: 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 Measures

  • symptomatic intracerebral hemorrhage
    • Time Frame: 48 hours after initiation of IVT
    • incidence of symptomatic intracerebral hemorrhage 48 hours after initiation of IVT

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Medicine and Pharmacy at Ho Chi Minh City
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tinh Quang DANG, MD – University of Medicine and Pharmacy at Ho Chi Minh City
  • Overall Contact(s)
    • TINH Dang Quang, MD, 0084 783629421, tinh942008@gmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.