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.

Neuroscience Trials Australia9 sites in 2 countries70 target enrollmentJune 2012

ConditionsIschemic Stroke

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Ischemic Stroke
Sponsor: Neuroscience Trials Australia
Enrollment: 70
Locations: 9
Primary Endpoint: Reperfusion at 24 hours (CT or MR perfusion imaging)
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

December 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Neuroscience Trials Australia

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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

Outcomes

Primary Outcomes

Reperfusion at 24 hours (CT or MR perfusion imaging)

Time Frame: 24 hours post stroke onset

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 Outcomes

Reperfusion at 24 hrs post stroke without symptomatic intracerebral hemorrhage (CT or MR perfusion imaging)(24 hours post stroke onset)
Recanalisation at 24 hrs post stroke (CT or MR angiography)(24 hours post stroke onset)
Infarct growth within 24 hrs (CT and MRI)(24 hours post stroke onset)
Stroke severity (NIHSS) at 24 hours(24 hours post stroke onset)
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).(within 36 hours of intervention)
Death due to any cause(3 months)
Modified Rankin Scale (mRS) 0-1 at 3 months(3 months)
Categorical shift in mRS at 3 months(3 months)
NIHSS reduction 8 points or reaching 0-1 at 3 months(3 months)
Modified Rankin Scale (mRS) 0-2 at 3 months(3 months)