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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01492725
Recruitment Status : Terminated (On DSMB advice, trial recruitment has been halted for efficacy. F/U continues)
First Posted : December 15, 2011
Last Update Posted : April 21, 2015
Information provided by (Responsible Party):
Neuroscience Trials Australia

Brief Summary:
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 or disease Intervention/treatment Phase
Ischemic Stroke Device: Intra-arterial Clot Retrieval with Solitaire device Genetic: intravenous tissue plasminogen activator (tPA) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : June 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Reperfusion at 24 hours (CT or MR perfusion imaging) [ Time Frame: 24 hours post stroke onset ]
  2. Favourable clinical response at 3 days(National Institutes of Health Stroke Score - NIHSS) [ Time Frame: 3 days post stroke onset ]
    NIHSS - reduction >/= 8 points or reaching 0-1)

Secondary Outcome Measures :
  1. Reperfusion at 24 hrs post stroke without symptomatic intracerebral hemorrhage (CT or MR perfusion imaging) [ Time Frame: 24 hours post stroke onset ]
  2. Recanalisation at 24 hrs post stroke (CT or MR angiography) [ Time Frame: 24 hours post stroke onset ]
  3. Infarct growth within 24 hrs (CT and MRI) [ Time Frame: 24 hours post stroke onset ]
  4. Stroke severity (NIHSS) at 24 hours [ Time Frame: 24 hours post stroke onset ]
  5. 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 ]
  6. Death due to any cause [ Time Frame: 3 months ]
  7. Modified Rankin Scale (mRS) 0-1 at 3 months [ Time Frame: 3 months ]
  8. Categorical shift in mRS at 3 months [ Time Frame: 3 months ]
  9. NIHSS reduction 8 points or reaching 0-1 at 3 months [ Time Frame: 3 months ]
  10. Modified Rankin Scale (mRS) 0-2 at 3 months [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492725

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Australia, New South Wales
John Hunter Hospital
New Lambton Heights, New South Wales, Australia, 2305
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2605
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Western Hospital
Melbourne, Victoria, Australia, 3011
Austin Hospital
Melbourne, Victoria, Australia, 3084
Box Hill Hospital
Melbourne, Victoria, Australia, 3128
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
Royal Melbourne Hospital
Melbourne, Victoria, Australia
New Zealand
Auckland Hospital
Grafton, Auckland, New Zealand, 1001
Sponsors and Collaborators
Neuroscience Trials Australia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Neuroscience Trials Australia
ClinicalTrials.gov Identifier: NCT01492725    
Other Study ID Numbers: NTA1101
First Posted: December 15, 2011    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: December 2014
Additional relevant MeSH terms:
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Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action