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Tenecteplase in Wake-up Ischaemic Stroke Trial

NCT03181360 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2021-05-14

No results posted yet for this study

Summary

Stroke is a leading causes of death and disability. At least 20% of strokes occur during sleep, so- called 'wake up stroke'. Thrombolysis with the clot-busting drug alteplase is effective for acute ischaemic stroke, provided that it is given within 4.5 hours of symptom onset. Patients with wake-up stroke are currently ineligible for clot-busting therapy. Previous studies indicate that many wake-up strokes occur just before awakening.

In this study, patients with wake-up stroke will be randomized to thrombolysis with tenecteplase and best standard treatment or to best standard treatment without thrombolysis. Tenecteplase has several potential advantages over alteplase, including very rapid action and that it can be given as a single injection. Prior to thrombolysis, a brain scan must be done to exclude bleeding or significant brain damage as a result from the stroke. We will use a CT scan to inform this decision. CT is used as a routine examination in all stroke patients. Other studies testing clot-busting treatment in wake-up stroke are using alteplase and more complex brain scans, which are not routinely available in the emergency situation in all hospitals.

Conditions

Interventions

DRUG

Tenecteplase

Single dose intravenous injection of recombinant fibrin-specific tissue plasminogen activator (tenecteplase) 0.25 mg (200 IU) per kg body weight up to a maximum of 25 mg (5000 IU), given as a bolus over approx. 10 seconds.

OTHER

Control

Best standard treatment

Sponsors & Collaborators

  • UiT The Arctic University of Norway

    collaborator OTHER

  • The Royal Norwegian Ministry of Health

    collaborator OTHER

  • Norwegian Health Association

    collaborator OTHER

  • University Hospital of North Norway

    lead OTHER

Principal Investigators

  • Ellisiv B Mathiesen · University Hospital of North Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-12
Primary Completion
2021-12-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Estonia
  • Finland
  • Latvia
  • Lithuania
  • New Zealand
  • Norway
  • Sweden
  • Switzerland
  • United Kingdom

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 NCT03181360 on ClinicalTrials.gov