A Pilot study to compare standard "clot-busting" drug treatment for stroke (alteplase) with a newer drug treatment (tenecteplase)

Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis – pilot phase - Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024541-67-GB

Enrollment

104

Registered

2011-09-28

Start date

2011-11-10

Completion date

Unknown

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischaemic Stroke MedDRA version: 14.0 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Metalyse Product Name: Tenecteplase Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Tenecteplase CAS Number: 191588-94-0 Current Sponsor code: Not

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Clinical diagnosis of supratentorial acute ischaemic stroke • Male or non-pregnant female =18 years of age • Within 4.5 hours of onset as defined by time since last known well • CTP and CTA examinations acquired prior to treatment Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64

Exclusion criteria

Exclusion criteria: • Contraindications to thrombolytic drug treatment for stroke o Evidence of intracranial haemorrhage or significant non-stroke intracranial pathology on pre-treatment CT o Established hypodensity on pre-treatment brain CT of more than one third of the MCA territory or ASPECT score 22mmol/l o Pregnancy • Known impaired renal function (eGFR <30ml/min) precluding contrast CT • Known allergy to radiological contrast • Severe concurrent medical condition that would prevent participation in study procedures (e.g. cardiac failure with severe pulmonary oedema) or with life expectancy = 3 months.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the safety and preliminary markers of effectiveness (using brain imaging) of tenecteplase compared to alteplase in acute ischaemic stroke.;Secondary Objective: To provide data on sample size and event rates to inform the design of a definitive, confirmatory, pragmatic, randomized, controlled trial with clinical end-points.;Primary end point(s): • Percent penumbral salvage at 24-48h (initial CTP-defined penumbra volume versus 24-48h CT infarct volume);Timepoint(s) of evaluation of this end point: Scans are obtained at 24-48 hours after stroke onset. The analysis will be conducted at the end of the trial in order to allow blinding and random ordering of scans.	—

Measure

Time frame

Main Objective: To determine the safety and preliminary markers of effectiveness (using brain imaging) of tenecteplase compared to alteplase in acute ischaemic stroke.;Secondary Objective: To provide data on sample size and event rates to inform the design of a definitive, confirmatory, pragmatic, randomized, controlled trial with clinical end-points.;Primary end point(s): • Percent penumbral salvage at 24-48h (initial CTP-defined penumbra volume versus 24-48h CT infarct volume);Timepoint(s) of evaluation of this end point: Scans are obtained at 24-48 hours after stroke onset. The analysis will be conducted at the end of the trial in order to allow blinding and random ordering of scans.

—

Secondary

Measure	Time frame
Secondary end point(s): • Proportion of Patients exhibiting recanalisation by CTA 24-48h after treatment • Early Clinical improvement (NIHSS score reduced by ³4 points, or 0 or 1) at 24h • Proportion of patients with symptomatic ICH (SICH) on 24-48h CT: - SITS-MOST definition - PH2/PHr2 + NIHSS deterioration by ³4 points at 24h - Any ICH • Distribution of functional outcome scores at day 30 and day 90 (measured on mRS) • Proportion of patients with favourable clinical outcome at day 30 and day 90 (mRS 0-1) • Average “home time” (number of nights spent in non-institutional private residence) by 90 days • Mortality at day 90 ;Timepoint(s) of evaluation of this end point: Clinical end-points are recorded at day 30 and day 90 after stroke. Imaging end-points are collected at 24-48 hours. End-points will be analysed at the end of the trial.	—

Measure

Time frame

Secondary end point(s): • Proportion of Patients exhibiting recanalisation by CTA 24-48h after treatment • Early Clinical improvement (NIHSS score reduced by ³4 points, or 0 or 1) at 24h • Proportion of patients with symptomatic ICH (SICH) on 24-48h CT: - SITS-MOST definition - PH2/PHr2 + NIHSS deterioration by ³4 points at 24h - Any ICH • Distribution of functional outcome scores at day 30 and day 90 (measured on mRS) • Proportion of patients with favourable clinical outcome at day 30 and day 90 (mRS 0-1) • Average “home time” (number of nights spent in non-institutional private residence) by 90 days • Mortality at day 90 ;Timepoint(s) of evaluation of this end point: Clinical end-points are recorded at day 30 and day 90 after stroke. Imaging end-points are collected at 24-48 hours. End-points will be analysed at the end of the trial.

—

Countries

United Kingdom

Contacts

Public ContactKeith Muir

University of Glasgow

k.muir@clinmed.gla.ac.uk0141 201 2494

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026