POSITIVE Stroke Clinical Trial

Stopped early · Not applicable

Conditions studied: Ischemic Stroke

In brief

Primary Endpoint: The primary objective is to show that AIS patients, ineligible for or refractory to treatment with IV-tPA, with appropriate image selection, treated with mechanical thrombectomy within 6-12 hours of symptom onset have less stroke related disability and improved good functional outcomes as compared to those treated with best MT with respect to endpoint defined as: • 90-day global disability assessed via the modified Rankin score (mRS), analyzed using raw mRS scores. Statistical details can be found in section 7.2. Secondary Endpoints: * 90-day global disability in the 6-12 hr cohort assessed via the overall distribution of mRS * Proportion of patients with good functional recovery for the 6-12 hr cohort as defined by mRS 0-2 at 90 days * Mortality at 30 and 90 days * Intracranial hemorrhage with neurological deterioration (NIHSS worsening \>4) within 24 hours of randomization * Procedure related serious adverse events (SAE's) * Arterial revascularization measured by TICI 2b or 3 following device use

Key facts

Study ID

NCT01852201

Run by

Medical University of South Carolina

People needed

33

Starts

2013-09-01

Expected to finish

2017-05-31

Last updated by the study team

2019-11-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 6-12 hours of when groin puncture can be obtained
• Neuroimaging demonstrates large vessel proximal occlusion (distal ICA through MCA 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)
• Pts are within 6-12 hours of symptom onset, that have received IV-tPA 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 Modified Rankin Scale score 0-1
• Consenting requirements met according to local IRB

You may not qualify if…

• 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 hemorrhage in the last 90 days
• Known irreversible bleeding disorder
• Known hereditary or acquired hemorrhagic 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 to, or contraindication to medications used in treatment of the stroke
• Contraindication to CT and 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 breast-feeding (Women of child-bearing 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 randomization
• 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 are unwilling or unable to comply with the protocol's follow up appointment schedule (based on the investigator's judgment)
• Head CT or MRI Scan Exclusion Criteria
• Presence of blood on imaging (subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH), etc.)
• High density lesion consistent with hemorrhage 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

Where it is running

• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Swedish/Colorado Neurological Institute — Englewood, Colorado, United States
• Baptist Health — Jacksonville, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Univesity of Massachusetts-Worcester — Worcester, Massachusetts, United States
• Saint Luke's Hospital — Kansas City, Missouri, United States
• Captial Health — Trenton, New Jersey, United States
• University of Buffalo Neurosurgery — Buffalo, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Stony Brook Medical Center — Stony Brook, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio Health — Columbus, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Tennessee Interventional Associates — Chattanooga, Tennessee, United States
• Fort Sanders Regional Medical Center — Knoxville, Tennessee, United States
• Methodist Healthcare - Memphis — Memphis, Tennessee, United States
• Vanderbilt University — Nashville, Tennessee, United States
• West Virginia University — Morgantown, West Virginia, United States
• Wisconsin University — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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