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Trial Title

Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis  (ATTEST 2)

Short Title

ATTEST 2

Clinical Phase

PHASE 3

Trial Design

Prospective Randomised Open, Blinded End-point (PROBE)

Trial Participants

Acute ischaemic stroke patients eligible to receive IV thrombolysis within guidelines (currently <4.5h after onset, with no upper age limit) based on CT imaging.

Planned Sample Size

1870

Treatment duration

Single dose administration

Follow up duration

90 days

Outcome Measures

Primary 
  • 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 
  • Full neurological recovery (mRS 0-1 versus 2-6).
  • Independent recovery (mRS score 0-2 versus 3-6).
  • Early major neurological improvement of 8 or more points, or return to NIHSS total score of 0 or 1, at 24 hours.
  • Health Related Quality of Life (EQ-5D) at day 90.
  • Barthel Index scores at day 90.
  • Need for thrombectomy.

Safety Outcomes
  • Mortality.
  • Symptomatic intracranial haemorrhage rates defined as local or remote parenchymal haemorrhage type 2 (PH2 or PHr2 ICH by ECASS 2 definition) on any post-treatment imaging scan up to 36h, combined with a neurological deterioration of 4 points or more on the NIHSS from baseline, or from the lowest NIHSS value between baseline and 24h, or leading to death (SITS-MOST definition).
  • SICH by ECASS-2 and ECASS-3 definitions.
  • PH2 haemorrhage on post-treatment CT up to 36h after treatment.
  • Any intracranial haemorrhage on 22-36h CT.
  • Significant extracranial haemorrhage (requirement for blood transfusion or drop in haemoglobin of ≥20mg/l in the 36h after treatment).

Investigational Medicinal Product(s)

Tenecteplase (TNK)

Alteplase

Formulation, Dose, Route of Administration

IV tenecteplase 0.25 mg/kg (single bolus, maximum 25 mg) or IV alteplase 0.9 mg/kg (10% bolus & 90% as IV infusion over 1 hour, maximum 90 mg).