Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis (ATTEST 2)
Overview
- Phase
- Phase 3
- Intervention
- Intravenous recombinant tissue plasminogen activator (rtPA) Alteplase
- Conditions
- Ischemic Stroke
- Sponsor
- NHS Greater Glasgow and Clyde
- Enrollment
- 1858
- Locations
- 1
- Primary Endpoint
- modified Rankin Scale
- Status
- Completed
- Last Updated
- last year
Overview
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?
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Alteplase - standard care
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).
Intervention: Intravenous recombinant tissue plasminogen activator (rtPA) Alteplase
Tenecteplase
Tenecteplase 0.25mg/kg administered as a single rapid intravenous bolus (maximum dose 25mg).
Intervention: Intravenous Tenecteplase
Outcomes
Primary Outcomes
modified Rankin Scale
Time Frame: 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 Outcomes
- 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)
- Health Related Quality of Life (EuroQol five dimensions questionnaire, EQ-5D)(Day 90 (+/- 7))
- Barthel Index score(Day 90 (+/- 7))
- Need for thrombectomy(24 hours)
- Full neurological recovery (modified Rankin Scale 0-1 versus 2-6).(Day 90 (+/- 7))
- Independent recovery (modified Rankin Scale score 0-2 versus 3-6).(Day 90 (+/- 7))