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

NCT ID: NCT04170647

Last Updated: 2019-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2020-01-01

Brief Summary

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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

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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.

Conditions

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Stroke, Ischemic Stroke, Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Medicine and Pharmacy at Ho Chi Minh City

OTHER

Sponsor Role lead

Responsible Party

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Tinh Quang DANG

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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115 People's Hospital

Ho Chi Minh City, , Vietnam

Site Status RECRUITING

Countries

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Vietnam

Central Contacts

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TINH Dang Quang, MD

Role: CONTACT

0084 783629421

Facility Contacts

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THANG Nguyen Huy, MD, PhD

Role: primary

0084 783629422

Other Identifiers

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UMP11192019

Identifier Type: -

Identifier Source: org_study_id

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