Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial (EXTEND-IA)

This study is currently recruiting participants.
Verified April 2013 by National Stroke Research Institute, Australia
Sponsor:
Information provided by (Responsible Party):
National Stroke Research Institute, Australia
ClinicalTrials.gov Identifier:
NCT01492725
First received: November 20, 2011
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

Patients presenting to the emergency department with acute ischaemic stroke, who are eligible for standard intravenous tPA therapy within 4.5 hours of stroke onset will be assessed for "dual target" major vessel occlusion and mismatch to determine their eligibility for randomisation into the trial. If the patient gives informed consent they will be randomised 50:50 using central computerised allocation to intra-arterial clot retrieval after IV tPA or IV tPA alone. The trial is prospective, randomised, open-label, blinded endpoint (PROBE) design.


Condition Intervention Phase
Ischemic Stroke
Device: Intra-arterial Clot Retrieval with Solitaire device
Genetic: intravenous tissue plasminogen activator (tPA)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Intra-arterial Reperfusion Therapy After Standard Dose Intravenous t-PA Within 4.5 Hours of Stroke Onset Utilizing Dual Target Imaging Selection.

Resource links provided by NLM:


Further study details as provided by National Stroke Research Institute, Australia:

Primary Outcome Measures:
  • Reperfusion at 24 hours (CT or MR perfusion imaging) [ Time Frame: 24 hours post stroke onset ] [ Designated as safety issue: No ]
  • Favourable clinical response at 3 days(National Institutes of Health Stroke Score - NIHSS) [ Time Frame: 3 days post stroke onset ] [ Designated as safety issue: No ]
    NIHSS - reduction >/= 8 points or reaching 0-1)


Secondary Outcome Measures:
  • Reperfusion at 24 hrs post stroke without symptomatic intracerebral hemorrhage (CT or MR perfusion imaging) [ Time Frame: 24 hours post stroke onset ] [ Designated as safety issue: Yes ]
  • Recanalisation at 24 hrs post stroke (CT or MR angiography) [ Time Frame: 24 hours post stroke onset ] [ Designated as safety issue: No ]
  • Infarct growth within 24 hrs (CT and MRI) [ Time Frame: 24 hours post stroke onset ] [ Designated as safety issue: No ]
  • Stroke severity (NIHSS) at 24 hours [ Time Frame: 24 hours post stroke onset ] [ Designated as safety issue: No ]
  • Symptomatic intra-cranial hemorrhage (ECASS type 2 parenchymal hematoma on CT or MRI combined with >/=4 point deterioration in NIHSS within 36 hours of treatment). [ Time Frame: within 36 hours of intervention ] [ Designated as safety issue: Yes ]
  • Death due to any cause [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Modified Rankin Scale (mRS) 0-1 at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Categorical shift in mRS at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • NIHSS reduction 8 points or reaching 0-1 at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Modified Rankin Scale (mRS) 0-2 at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intra-arterial Clot Retrieval after iv tPA Device: Intra-arterial Clot Retrieval with Solitaire device
Intra-arterial mechanical clot retrieval with the Solitaire device after patients have received standard therapy with intravenous tissue plasminogen activator (tPA). Clot retrieval involves cerebral angiography and takes approximately 2 hours.
Active Comparator: Standard care iv tPA Genetic: intravenous tissue plasminogen activator (tPA)
Standard care IV tPA therapy administered as per registered product information

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients presenting with anterior circulation acute ischaemic stroke eligible using standard criteria to receive IV tPA within 4.5 hours of stroke onset
  2. Patient, family member or legally responsible person depending on local ethics requirements has given informed consent
  3. Patient‟s age is ≥18 years
  4. Intra-arterial clot retrieval treatment can commence (groin puncture) within 6 hours of stroke onset.

    Imaging inclusion criteria

    Dual target:

  5. Arterial occlusion on CTA or MRA of the ICA, M1 or M2
  6. Mismatch - Using CT or MRI with a Tmax >6 second delay perfusion volume and either CT-rCBF or DWI infarct core volume. a) Mismatch ratio of greater than 1.2, and b) Absolute mismatch volume of greater than 10 ml, and. c) Infarct core lesion volume of less than 70mL

Exclusion Criteria:

  1. Intracranial haemorrhage (ICH) identified by CT or MRI
  2. Rapidly improving symptoms at the discretion of the investigator
  3. Pre-stroke mRS score of ≥ 2 (indicating previous disability)
  4. Inability to access the cerebral vasculature in the opinion of the neurointerventional team
  5. Contra indication to imaging with MR with contrast agents
  6. Participation in any investigational study in the previous 30 days
  7. Any terminal illness such that patient would not be expected to survive more than 1 year
  8. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
  9. Pregnant women
  10. Previous stroke within last three months
  11. 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.
  12. Current use of oral anticoagulants and a prolonged prothrombin time (INR > 1.6)
  13. Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hours and a prolonged activated partial thromboplastin time exceeding the upper limit of the local laboratory normal range.
  14. Use of glycoprotein IIb - IIIa inhibitors within the past 72 hours. Prior use of single or dual agent oral platelet inhibitors (clopidogrel and/or low-dose aspirin) is permitted.
  15. Clinically significant hypoglycaemia.
  16. 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.
  17. Hereditary or acquired haemorrhagic diathesis
  18. Gastrointestinal or urinary bleeding within the preceding 21 days
  19. Major surgery within the preceding 14 days which poses risk in the opinion of the investigator.
  20. Exposure to a thrombolytic agent within the previous 72 hrs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492725

Contacts
Contact: Bruce Dr Campbell +61 3 9342 7000 bruce.campbell@mh.org.au

Locations
Australia, New South Wales
John Hunter Hospital Recruiting
New Lambton Heights, New South Wales, Australia, 2305
Contact: Mark Parsons, Dr.       mark.parsons@hnehealth.nsw.gov.au   
Principal Investigator: Mark Parsons, Dr         
Royal North Shore Hospital Recruiting
St Leonards, New South Wales, Australia, 2605
Contact: Martin Krause, A/Prof.         
Principal Investigator: Martin Krause, A/Prof.         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Timothy Kleinig, Dr.         
Principal Investigator: Timothy kleinig, Dr.         
Australia, Victoria
Royal Melbourne Hospital Recruiting
Melbourne, Victoria, Australia
Contact: Stephen Davis         
Principal Investigator: Stephen Davis         
Austin Hospital Recruiting
Melbourne, Victoria, Australia, 3084
Principal Investigator: Helen Dewey         
Box Hill Hospital Recruiting
Melbourne, Victoria, Australia, 3128
Contact: Christopher Bladin         
Principal Investigator: Christopher Bladin         
Monash Medical Centre Recruiting
Melbourne, Victoria, Australia, 3168
Contact: Thanh Phan         
Principal Investigator: Than Phan         
Western Hospital Recruiting
Melbourne, Victoria, Australia, 3011
Contact: Tissa Wijeratne         
Principal Investigator: Tissa Wijeratne         
New Zealand
Auckland Hospital Recruiting
Grafton, Auckland, New Zealand, 1001
Contact: Alan Barber, Prof.         
Principal Investigator: Alan Barber, Prof.         
Sponsors and Collaborators
National Stroke Research Institute, Australia
  More Information

No publications provided by National Stroke Research Institute, Australia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Stroke Research Institute, Australia
ClinicalTrials.gov Identifier: NCT01492725     History of Changes
Other Study ID Numbers: NTA1101
Study First Received: November 20, 2011
Last Updated: April 30, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Plasminogen
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on April 17, 2014