Status:
TERMINATED
Extending the Time for Thrombolysis in Emergency Neurological Deficits - Intra-Arterial
Lead Sponsor:
Neuroscience Trials Australia
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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" m...
Eligibility Criteria
Inclusion
- Patients presenting with anterior circulation acute ischaemic stroke eligible using standard criteria to receive IV tPA within 4.5 hours of stroke onset
- Patient, family member or legally responsible person depending on local ethics requirements has given informed consent
- Patient"s age is ≥18 years
- Intra-arterial clot retrieval treatment can commence (groin puncture) within 6 hours of stroke onset.
- Imaging inclusion criteria
- Dual target:
- Arterial occlusion on CTA or MRA of the ICA, M1 or M2
- 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
- Intracranial haemorrhage (ICH) identified by CT or MRI
- Rapidly improving symptoms at the discretion of the investigator
- Pre-stroke mRS score of ≥ 2 (indicating previous disability)
- Inability to access the cerebral vasculature in the opinion of the neurointerventional team
- Contra indication to imaging with MR with contrast agents
- 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, 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.
- Pregnant women
- 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 partial thromboplastin time exceeding the upper limit of the local laboratory normal range.
- 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.
- 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 hrs
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01492725
Start Date
June 1 2012
End Date
December 1 2014
Last Update
April 21 2015
Active Locations (9)
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1
John Hunter Hospital
New Lambton Heights, New South Wales, Australia, 2305
2
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2605
3
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
4
Western Hospital
Melbourne, Victoria, Australia, 3011