Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis

Phase 3

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: Intravenous recombinant tissue plasminogen activator (rtPA) Alteplase; Drug: Intravenous Tenecteplase

• Registration Number: NCT02814409
• Lead Sponsor: NHS Greater Glasgow and Clyde

Brief Summary

The principle research question is: in patients with acute ischaemic stroke eligible for intravenous (IV) thrombolysis, is tenecteplase superior in efficacy to alteplase, based on functional outcome as assessed by modified Rankin Scale distribution at day 90?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-23
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-27
• Study Start: 2016-12-15
• Primary Completion: 2023-08-31
• Study Completion: 2024-01-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1858

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alteplase - standard care	Intravenous recombinant tissue plasminogen activator (rtPA) Alteplase	Alteplase 0.9 mg/kg with 10% of the total dose administered as an initial intravenous bolus and remaining 90% of the total dose administered as an intravenous infusion over 1 hour (maximum dose 90mg).
Tenecteplase	Intravenous Tenecteplase	Tenecteplase 0.25mg/kg administered as a single rapid intravenous bolus (maximum dose 25mg).

Primary Outcome Measures

Name	Time	Method
modified Rankin Scale	Day 90 (+/- 7)	modified Rankin Scale (mRS) at day 90, determined by the Rankin Focused Assessment (RFA) method using centralised telephone interview, analysed by ordinal distribution ("shift") analysis of the scores in intervention and control groups.

Secondary Outcome Measures

Name	Time	Method
Early major neurological improvement of 8 or more points, or return to the National Institutes of Health Stroke Scale (NIHSS) total score of 0 or 1 at 24 hour(s).	24 hours	Early major neurological improvement of 8 or more points, or return to the National Institutes of Health Stroke Scale (NIHSS) total score of 0 or 1 at 24 hour(s).
Health Related Quality of Life (EuroQol five dimensions questionnaire, EQ-5D)	Day 90 (+/- 7)	Health Related Quality of Life (EuroQol five dimensions questionnaire, EQ-5D)
Barthel Index score	Day 90 (+/- 7)	Barthel Index score
Need for thrombectomy	24 hours	Need for thrombectomy
Full neurological recovery (modified Rankin Scale 0-1 versus 2-6).	Day 90 (+/- 7)	Full neurological recovery (modified Rankin Scale 0-1 versus 2-6).
Independent recovery (modified Rankin Scale score 0-2 versus 3-6).	Day 90 (+/- 7)	Independent recovery (modified Rankin Scale score 0-2 versus 3-6).

Trial Locations

Locations (1)

Queen Elizabeth University Hospital; 🇬🇧 Glasgow, United Kingdom