CompletedNCT02814409ATTEST2Updated Jun 13, 2024

Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis

A Phase 3 interventional study of Intravenous recombinant tissue plasminogen activator (rtPA) Alteplase and Intravenous Tenecteplase in Ischemic Stroke, sponsored by NHS Greater Glasgow and Clyde. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-13.

Sponsored by NHS Greater Glasgow and Clyde · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 1,858
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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?

Conditions studied

Ischemic Stroke

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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 1,858 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

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Lead sponsor

NHS Greater Glasgow and Clyde is the lead sponsor of 215 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Eligible for intravenous thrombolysis.
Male or non-pregnant female ≥18 years of age.
\<4.5h after symptom onset.
Consent of patient or legal representative.
Independent prior to the stroke (estimated modified Rankin Scale 0-2).

Exclusion criteria

Exclusion criteria:

Eligible for intravenous thrombolysis: Evidence of intracranial haemorrhage or significant non-stroke intracranial pathology likely to account for clinical presentation or represent a risk of intracerebral haemorrhage (eg Central Nervous System neoplasm) on pre-treatment computerised tomography (CT) scan; Stroke within the previous 14 days, thrombolytic therapy within the past 14 days, or hypodensity on pre-treatment computerised tomography (CT) scan consistent with recent cerebral ischaemia other than the presenting event; Systolic blood pressure more than 185 or diastolic blood pressure more than 110 mmHg, or aggressive management (intravenous pharmacotherapy) necessary to reduce blood pressure to these limits; Clinical history suggestive of subarachnoid haemorrhage even if no blood is evident on computerised tomography (CT) scan; High risk of haemorrhage, including major surgery, trauma or gastrointestinal or urinary tract haemorrhage within the previous 21 days; Arterial puncture at a non-compressible site within the previous 7 days; Prolonged cardiopulmonary resuscitation (> 2 minutes) within the previous 14 days; Acute pericarditis and/or subacute bacterial endocarditis; acute pancreatitis; Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis; Active peptic ulceration; Known history of haemorrhagic stroke; Known defect of clotting or platelet function (other than antiplatelet therapy); Hypo- or hyperglycaemia (blood glucose \<2 mmol/l or >18 mmol/l) sufficient to account for neurological symptoms; Seizure at onset of symptoms unless brain imaging identifies positive evidence of significant brain ischaemia (eg early ischaemic change or hyperdense vessel on plain computerised tomography (CT) scan, computerised tomography angiography (CTA) scan confirmed arterial occlusion); Pregnancy (for women of child-bearing potential a negative pregnancy test will be required prior to randomisation); Inadequate haemostasis: Taking warfarin and international normalised ratio (INR) >1.3, Taking a Direct Oral Anticoagulant (dabigatran, rivaroxaban, apixaban, edoxaban) unless known to be >12 hours since last dose and with normal coagulation assays, Low molecular weight heparin (at doses other than prophylaxis of venous thromboembolism) administered within the preceding 48 hours, Unfractionated heparin administered within the previous 48 hours and activated partial thromboplastin time (APTT) is prolonged.
Any major medical condition likely to limit survival to day 90.
Unavailable for day 90 follow-up.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 1,858 participants (actual)

Study arms

Active comparator
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).
Drug: Intravenous recombinant tissue plasminogen activator (rtPA) Alteplase
Experimental
Tenecteplase
Tenecteplase 0.25mg/kg administered as a single rapid intravenous bolus (maximum dose 25mg).
Drug: Intravenous Tenecteplase

Interventions

DrugIntravenous recombinant tissue plasminogen activator (rtPA) Alteplase
IV Alteplase 0.9mg/kg (max 90mg) bolus + 1h infusion
Also known as: Actilyse, recombinant tissue plasminogen activator (rtPA)
DrugIntravenous Tenecteplase
IV Tenecteplase 0.25mg/kg (max 25mg) single bolus
Also known as: Metalyse, TNK

What researchers measure

Primary outcomes

modified Rankin Scale
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.
Time frame: Day 90 (+/- 7)

Secondary outcomes

Full neurological recovery (modified Rankin Scale 0-1 versus 2-6).
Full neurological recovery (modified Rankin Scale 0-1 versus 2-6).
Time frame: Day 90 (+/- 7)
Independent recovery (modified Rankin Scale score 0-2 versus 3-6).
Independent recovery (modified Rankin Scale score 0-2 versus 3-6).
Time frame: Day 90 (+/- 7)
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).
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).
Time frame: 24 hours
Health Related Quality of Life (EuroQol five dimensions questionnaire, EQ-5D)
Health Related Quality of Life (EuroQol five dimensions questionnaire, EQ-5D)
Time frame: Day 90 (+/- 7)
Barthel Index score
Barthel Index score
Time frame: Day 90 (+/- 7)
Need for thrombectomy
Need for thrombectomy
Time frame: 24 hours

Other outcomes

Mortality
Mortality
Time frame: Day 90 (+/- 7)
Imaging scan up to 36 hours, combined with a neurological deterioration NIHSS≥4 points from baseline (or lowest NIHSS value baseline-24 h), or leading to death (Safe Implementation of Thrombolysis in Stroke-Monitoring study definition).
Imaging scan up to 36 hours, combined with a neurological deterioration NIHSS≥4 points from baseline (or lowest NIHSS value baseline-24 h), or leading to death (Safe Implementation of Thrombolysis in Stroke-Monitoring study definition).
Time frame: 36 hours
Symptomatic Intra-Cerebral Haemorrhage (SICH) by (European Cooperative Acute Stroke Study) ECASS-2 and ECASS-3 definitions.
Symptomatic Intra-Cerebral Haemorrhage (SICH) by (European Cooperative Acute Stroke
Time frame: up to day 90
Parenchymal Haematoma type 2 (PH2) haemorrhage on post-treatment computerised tomography (CT) scan up to 36 hours after treatment.
Parenchymal Haematoma type 2 (PH2) haemorrhage on post-treatment computerised
Time frame: 36 hours
Intracranial haemorrhage
Any intracranial haemorrhage on 22-36 hours computerised tomography (CT) scan
Time frame: 22-36 hours
Significant extracranial haemorrhage (requirement for blood transfusion or drop in haemoglobin of ≥20mg/l in the 36h after treatment).
Significant extracranial haemorrhage (requirement for blood transfusion or drop in haemoglobin of ≥20mg/l in the 36h after treatment).
Time frame: 36 hours

Study locations

1 site

Queen Elizabeth University Hospital
Glasgow, United Kingdom

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02814409
Lead sponsor: NHS Greater Glasgow and Clyde
Collaborators: University of Glasgow, University of Edinburgh, Oxford University Hospitals NHS Trust
Responsible party: Sponsor
First posted: Jun 27, 2016
Start date: Dec 15, 2016
Primary completion: Aug 31, 2023
Completion: Jan 10, 2024
Last update: Jun 13, 2024

Study contacts

Keith Muir, MD, FRCP

principal investigator · University of Glasgow

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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