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

Stroke, Acute Clinical Trial

Official title:

Reperfusion Rates of Intravenous Tissue-type Plasminogen Activator on Acute Ischemic Stroke Patients With Large Vessel Occlusions and Predictor Factors of Recanalization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04170647
• Other study ID #: UMP11192019
• Status: Recruiting
• Start date: October 1, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: November 2019
• Source: Ho Chi Minh City University of Medicine and Pharmacy
• Contact: TINH Dang Quang, MD
• Phone: 0084 783629421
• Email: tinh942008[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 81
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Stroke
• Stroke, Acute
• Stroke, Ischemic

Intervention

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

Locations

Country	Name	City	State
Vietnam	115 People's Hospital	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Ho Chi Minh City University of Medicine and Pharmacy

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reperfusion rate	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.	within 24 hours of hospitalization
Secondary	symptomatic intracerebral hemorrhage	incidence of symptomatic intracerebral hemorrhage 48 hours after initiation of IVT	48 hours after initiation of IVT