NCT01852201.

Trial name or title	PerfusiOn imaging Selection of Ischemic sTroke patIents for endoVascular thErapy (POSITIVE)
Methods	Randomised, single‐blinded trial
Participants	750 participants Inclusion criteria Age 18 and older (i.e. candidates must have had their 18th birthday) NIHSS ≥ 8 at the time of neuroimaging Presenting or persistent symptoms within 6 to 12 hours of when groin puncture can be obtained Neuroimaging demonstrates large vessel proximal occlusion (distal internal carotid artery through middle cerebral artery M1 bifurcation) The operator feels that the stroke can be appropriately treated with traditional endovascular techniques (endovascular mechanical thrombectomy without adjunctive devices such as stents) Patients within 6 to 12 hours of symptom onset who have received intravenous alteplase without improvement in symptoms are eligible for this study. Patients presenting earlier than 6 hours should be treated according to local standard of care Pre‐event mRS score 0 to 1 Consenting requirements met according to local institutional review board Exclusion criteria Patient is less than 6 hours from symptom onset Rapidly improving neurologic examination Absence of large vessel occlusion on non‐invasive imaging Known or suspected pre‐existing (chronic) large vessel occlusion in the symptomatic territory Absence of an associated large penumbra as defined by physiologic imaging according to standard of practice at the participating institution Any intracranial haemorrhage in the last 90 days Known irreversible bleeding disorder Known hereditary or acquired haemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 2.5 or institutionally equivalent prothrombin time of 2.5 times normal Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction Inability to tolerate, clinically documented evidence in medical history of adverse reaction, or contraindication to medications used in treatment of the stroke Contraindication to CT or MRI (i.e. iodine contrast allergy or other condition that prohibits imaging from either CT or MRI) Known allergy to contrast used in angiography that cannot be medically controlled Relative contraindication to angiography (e.g. serum creatinine > 2.5 mg/dL) Women who are currently pregnant or breastfeeding (women of childbearing potential must have a negative pregnancy test prior to the study procedure ‐ either serum or urine) Evidence of active infection (indicated by fever at or over 99.9 °F and/or open draining wound) at the time of randomisation Current use of cocaine or other vasoactive substance Any comorbid disease or condition expected to compromise survival or ability to complete follow‐up assessments through 90 days Patients who lack the necessary mental capacity to participate or who are unwilling or unable to comply with the protocol's follow‐up appointment schedule (based on the investigator's judgement) Head CT or MRI scan exclusion criteria Presence of blood on imaging (subarachnoid haemorrhage, intracerebral haemorrhage, etc.) High‐density lesion consistent with haemorrhage of any degree Significant mass effect with midline shift Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on the baseline CT scan or ASPECTS of < 7; sulcal effacement and/or loss of grey‐white differentiation alone are not contraindications for treatment
Interventions	Endovascular treatment plus best medical treatment or best medical treatment alone
Outcomes	mRS score at 90 days' follow‐up
Starting date	September 2013
Contact information	Adrian Parker 843‐792‐3164 parkerad@musc.edu
Notes	ClinicalTrials.gov identifier: NCT01852201 Not a trial of wake‐up stroke per se, but the trial will include a substantial proportion of participants with wake‐up stroke.