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EXTEND (International): Extending the Time for Thrombolysis in Emergency Neurological Deficits (International)

Information source: Neuroscience Trials Australia
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stroke

Intervention: Tissue Plasminogen Activator (Alteplase) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Neuroscience Trials Australia

Official(s) and/or principal investigator(s):
Geoffrey Donnan, MD FRACP, Principal Investigator, Affiliation: National Stroke Research Institute, Australia
Stephen Davis, MD FRACP, Principal Investigator, Affiliation: University of Melbourne

Overall contact:
Rachael McCoy, Phone: +613 9035 7232, Email: ecowley@neurotrialsaustralia.com

Summary

The primary hypothesis being tested in this trial is that ischaemic stroke patients selected with significant penumbral mismatch (according to imaging criteria) at 4. 5 (or 3 hours

depending on local guidelines) - 9 hours post onset of stroke or after 'wake up stroke'

(WUS) will have improved clinical outcomes when given intravenous tissue plasminogen activator (tPA) compared to placebo.

Clinical Details

Official title: Extending the Time for Thrombolysis in Emergency Neurological Deficits

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Modified Rankin Scale (mRS) 0-1

Secondary outcome:

Categorical shift in modified Rankin Score (mRS)

Change in ≥ 8 National Institutes of Health Stroke Scale (NIHSS) points or reaching ≤ 1 on this scale

Death due to any cause

Symptomatic Intracerebral Hemorrhage (ICH)

Reperfusion

Recanalisation

Infarct growth

Recurrent stroke

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients presenting with hemispheric acute ischaemic stroke

- Patient, family member or legally responsible person depending on local ethics

requirements has given informed consent

- Patient's age is ≥18 years (or as per local requirements)

- Treatment onset can commence within 4. 5 - 9 hours after stroke onset according to

registered product information, or within 3 - 9 hours according to locally accepted

guidelines.

- Patients who wake with stroke may be included if neurological and other exclusion

criteria are satisfied. These 'wake up' strokes are defined as having no symptoms at sleep onset, but stroke symptoms on waking. The time of stroke onset is to be taken as the mid-point between sleep onset (or last known to be normal) and time of waking. The maximum time window for randomisation is then 9 hours from the mid-point as described.

- Significant neurological deficit (eg. NIHSS score of ≥ 4 - 26) with clinical signs of

hemispheric infarction.

- Penumbral mismatch - A "hypo-perfusion to core" volume ratio of greater than 1. 2, and

an absolute difference greater than 10ml (using a Magnetic Resonance (MR) or Computed Tomography (CT) Tmax > 6 second delay), between perfusion lesion and MR-DWI or Computed Tomography-Cerebral Blood Flow (CT-CBF) core lesion.

- An infarct core lesion of less than or equal to 70ml using MR-DWI or CT-CBF

Exclusion Criteria:

- Intracranial haemorrhage (ICH) identified by CT or MRI

- Rapidly improving symptoms, particularly if in the judgment of the managing clinician

that the improvement is likely to result in the patient having an NIHSS score of < 4 at randomization

- Pre-stroke MRS score of ≥ 2 (indicating previous disability)

- Contra indication to imaging with contrast agents

- Infarct core >1/3 Middle Cerebral Artery (MCA) territory qualitatively

- Participation in any investigational study in the previous 30 days

- Any terminal illness such that patient would not be expected to survive more than 1

year

- Any condition that could impose hazards to the patient if study therapy is initiated

or affect the participation of the patient in the study (this applies to patients with severe microangiopathy such as haemolytic uremic syndrome or thrombotic thrombocytopenic purpura). The judgment is left to the discretion of the Investigator.

- Pregnant women (clinically evident)

- Previous stroke within last three months

- Recent past history or clinical presentation of ICH, subarachnoid haemorrhage (SAH),

arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm. At the discretion of each Investigator.

- Current use of oral anticoagulants and a prolonged prothrombin time (INR > 1. 6)

- Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hours

and a prolonged activated thromboplastin time exceeding the upper limit of the local laboratory normal range.

- Use of glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single or

dual agent oral platelet inhibitors (clopidogrel and/or low-dose aspirin) prior to study entry is permitted.

- Clinically significant hypoglycaemia.

- Uncontrolled hypertension defined by a blood pressure > 185 mmHg systolic or >110

mmHg diastolic on at least 2 separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood pressure to within these limits. The definition of "aggressive treatment" is left to the discretion of the responsible Investigator.

- Hereditary or acquired haemorrhagic diathesis

- Gastrointestinal or urinary bleeding within the preceding 21 days

- Major surgery within the preceding 14 days which poses risk in the opinion of the

investigator.

- Exposure to a thrombolytic agent within the previous 72 hours

Locations and Contacts

Rachael McCoy, Phone: +613 9035 7232, Email: ecowley@neurotrialsaustralia.com

China Medical University Hospital, Taichung 40447, Taiwan; Recruiting
Chung-Hsiang Liu, Dr
Chung-Hsiang Liu, Dr, Principal Investigator
Additional Information

Starting date: June 2012
Last updated: April 15, 2015

Page last updated: August 20, 2015

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