CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,600 enrolled
Drug / intervention
Tenecteplase +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03889249
NCT03889249Phase 3Completed

Alteplase Compared to Tenecteplase in Patients With Acute Ischemic Stroke: QuICR & OPTIMISE Registry Based Pragmatic Randomized Controlled Trial

University of Calgary·interventional·Posted Mar 26, 2019·Updated May 12, 2023

In Brief

A Phase 3 clinical trial evaluating Tenecteplase and Alteplase for Stroke, Acute and Thromboses, Intracranial. Completed, enrolled 1,600 participants across 22 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMar 26, 2019
Enrollment StartDec 10, 2019
Primary CompletionApr 26, 2022
Study CompletionApr 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 7.3 years ago

Interventions

Tenecteplasedrug

Stroke Thrombolytic

Alteplasedrug

Stroke Thrombolytic