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Alteplase Compared to Tenecteplase in Patients With Acute Ischemic Stroke

NCT03889249 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1600

Last updated 2023-05-12

No results posted yet for this study

Summary

The proposed trial is a pragmatic, registry linked, prospective, randomized (1:1) controlled, open-label parallel group clinical trial with blinded endpoint assessment of 1600 patients to test if intravenous tenecteplase (0.25 mg/kg body weight, max dose 25 mg) is non-inferior to intravenous alteplase (0.9 mg/kg body weight) in patients with acute ischemic stroke otherwise eligible for intravenous thrombolysis as per standard care. All patients will have standard of care medical management on an acute stroke unit. There are no additional trial specific management recommendations. Patients will be followed for approximately 90-120 days.

Conditions

  • Stroke, Acute
  • Thromboses, Intracranial

Interventions

DRUG

Tenecteplase

Stroke Thrombolytic

DRUG

Alteplase

Stroke Thrombolytic

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Bijoy K Menon, MD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-10
Primary Completion
2022-04-26
Completion
2023-04-30

Countries

  • Canada

Study Locations

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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 NCT03889249 on ClinicalTrials.gov