NCT04170647

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

November 20, 2019

Status Verified

November 1, 2019

Enrollment Period

2.3 years

First QC Date

November 18, 2019

Last Update Submit

November 18, 2019

Conditions

Keywords

reperfusionIVT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • symptomatic intracerebral hemorrhage

    48 hours after initiation of IVT

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute ischemic stroke patients presented at our hospital with LVO confirmed who received both intravenous tissue-type plasminogen activator and subsequent repeat angiography will be included in our study.

You may qualify if:

  • Age 18 and older with consent form signed.
  • Patients hospitalized in 115 People's Hospital for acute ischemic stroke.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

115 People's Hospital

Ho Chi Minh City, 700000, Vietnam

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeStroke

Interventions

Plasminogen Activators

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Central Study Contacts

TINH Dang Quang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 18, 2019

First Posted

November 20, 2019

Study Start

October 1, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

November 20, 2019

Record last verified: 2019-11

Locations