Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis- (ATTEST) "ATTEST"

Recruiting

Phase 2 Results N/A

Trial Description

A pilot evaluation of tenecteplase compared to alteplase in acute ischaemic stroke patients currently eligible for intravenous alteplase treatment in a prospective, randomised, blinded outcome evaluation clinical trial using brain imaging as a biomarker.

Detailed Description

Newer thrombolytic agents such as tenecteplase have pharmacological features (higher fibrin binding specificity and longer half-life) that may be advantageous when compared to older agents such as alteplase with respect to arterial recanalisation, ease of administration, and reduced bleeding risk. No other clinical trial is currently evaluating alternative thrombolytic strategies in patients who are eligible to receive standard intravenous alteplase, instead concentrating on extending the population for IV thrombolysis.
The ATTEST pilot phase will use brain imaging as a biomarker for key clinical response variables, with penumbral salvage as the primary end-point and secondary end-points including recanalisation as well as conventional clinical scales.
The findings of this study are anticipated to provide data on sample size and event rates to inform the design of a definitive, confirmatory, pragmatic, randomised, controlled trial with clinical endpoints.

Conditions

Interventions

  • Tenecteplase (TNKase)Drug
    Other Names: Metalyse
    Intervention Desc: Intravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg)
    ARM 1: Kind: Experimental
    Label: Tenecteplase 0.25 mg/kg
    Description: Intravenous tenecteplase 0.25 mg/kg (single bolus, maximum 25 mg)
  • Alteplase Drug
    Intervention Desc: Intravenous alteplase 0.9mg/kg to maximum of 90mg, given as 10% bolus and 90% of dose over 1 hour infusion
    ARM 1: Kind: Experimental
    Label: Alteplase 0.9 mg/kg
    Description: Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)
  • Intravenous Thrombolysis Other
    Intervention Desc: IV tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg) IV alteplase 0.9 mg/kg (10% bolus; 90% infusion over one hour; maximum dose 90 mg)
    ARM 1: Kind: Experimental
    Label: Tenecteplase 0.25 mg/kg
    Description: Intravenous tenecteplase 0.25 mg/kg (single bolus, maximum 25 mg)
    ARM 2: Kind: Experimental
    Label: Alteplase 0.9 mg/kg
    Description: Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Percent penumbral salvage at 24-48h (initial CTP-defined penumbra volume versus 24/48h CT infarct volume. 48 hours Yes
Secondary Proportion of patients exhibiting recanalisation (measured by CTA) 24-48 hours post treatment 48 hours Yes
Secondary Early clinical improvement 24 hours post treatment 24 hours Yes
Secondary Proportion of patients with symptomatic ICH (SICH) on 24-48 hour CT 48 hours Yes
Secondary Distribution of functional outcome scores (mRS) at Day 30 30 Days No
Secondary Distribution of functional outcome scores (mRS) at Day 90 90 days No
Secondary Proportion of patients with favourable clinical outcome (mRS 0-1) at Day 30 30 days No
Secondary Proportion of patients with favourable clinical outcome (mRS 0-1) at Day 90 90 days No
Secondary Average 'home time' by day 90 90 Days No
Secondary Mortality at Day 90 90 Days No
Primary Percent penumbral salvage at 24-48h (initial penumbra volume on computed tomography perfusion (CTP) imaging versus 24-48h CT infarct volume. 48 hours Yes
Secondary Proportion of patients exhibiting recanalisation (on computed tomography angiography, CTA) 24-48 hours post treatment 48 hours No
Secondary Proportion of patients with symptomatic intracerebral haemorrhage (SICH) on 24-48 hour CT 48 hours Yes
Secondary Distribution of functional outcome by modified Rankin Scale (mRS) scores at Day 30 30 Days No

Sponsors