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TNK-tPA Evaluation for Minor Ischemic Stroke With Proven Occlusion

NCT01654445 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-11-25

Study results available
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Summary

This trial will enroll patients that have been diagnosed with a transient ischemic attack (TIA) or minor stroke that has occurred within the past 12 hours. Anyone diagnosed with a minor stroke faces the possibility of long-term disability and even death, regardless of treatment. Stroke symptoms such as weakness, difficulty speaking and paralysis may improve or worsen over the hours or days immediately following a stroke. The purpose of this research trial is to study the effects of a clot-dissolving drug, tenecteplase (TNK-tPA), as a treatment for patients who arrive within twelve hours from stroke onset. This study is attempting to see if TNK-tPA given through a vein in the arm (intravenous) to patients is a safe treatment for stroke patients. Neither the safety nor the effectiveness of this treatment has been proven yet.

This trial will be conducted at several site in Canada.

Dr Michael Hill and Dr. Shelagh Coutts are the Principal Investigators of this trial, coordinated at the University of Calgary, Foothills Medical Centre.

Conditions

Interventions

DRUG

Tenecteplase

Tenecteplase will be given to the patient as an intravenous bolus over 1- 2 minutes within 90 minutes of the first slice of the CTA. This is an open-label trial, all patients will receive tenecteplase, either tier 1 or tier 2 dosage.

Sponsors & Collaborators

  • Vancouver General Hospital

    collaborator OTHER

  • Ottawa Hospital Research Institute

    collaborator OTHER

  • Hopital Charles Lemoyne

    collaborator OTHER

  • Université de Sherbrooke

    collaborator OTHER

  • Vancouver Island Health Authority

    collaborator OTHER

  • CHU de Quebec-Universite Laval

    collaborator OTHER

  • University of Calgary

    lead OTHER

Principal Investigators

  • Michael D Hill, MD,MSc FRCPC · University of Calgary

  • Shelagh B Coutts, MD,FRCPC · University of Calgary

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01654445 on ClinicalTrials.gov