Clinical Research Trial In-Service

JULY 2025

Agenda

• Overview of Current Trials

RESOURCES

Resources

• Stroke Center Research Coordinators

On call Mon – Fri, 7am to 4pm

Cell number 650-850-1499

• Study PIs and attending physicians
• CLIN ONE

https://www.clinone.com/

Easy access to all study-related materials

• Pocket cards/REDCap eScreening

Current Research Studies

BEACH �Biomarker and Edema Attenuation in IntraCerebral Hemorrhage��

PI: Chitra Venkat, Coordinator: Cindy Kim

DIAGNOSIS: ICH

STUDY OVERVIEW

Phase 2a pilot study to assess the safety and tolerability of MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH). MW189 is targeted to neuroinflammation and synaptic dysfunction mechanisms.

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OBJECTIVE: This study will monitor exploratory radiographic and clinical endpoints, explore the use of biochemical biomarkers to demonstrate target engagement and biological response to a potential new therapy - MW189

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BEACH Study

Enrolling during regular work hours (M – F 7am – 5pm)

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TARGET POPULATION

• Age 18+
• Pre-event mRS 0-4
• NIHSS score ≥2 or Glasgow Coma Scale ≥5
• Spontaneous, non-traumatic ICH
• 5 mL - 60 mL (stable on 6 hr CT scan)
• No planned surgical intervention
• Able to receive first dose </= 24 hrs of LKW

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Major Exclusions:

• T >38.5C, nonreversible
• bleeding diathesis
• secondary ICH

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Fellow Responsibilities ~�BEACH�

LIBREXIA Stroke �

PI: Nirali Vora, Coordinator: Riddhi Shah

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DIAGNOSIS: Ischemic Stroke and TIA

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STUDY OVERVIEW

Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention after an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

The primary hypothesis of this study is that milvexian 25 mg twice daily in addition to standard-of-care is superior to placebo in addition to standard-of-care in reducing the risk of the primary endpoint of ischemic stroke in participants with an acute ischemic stroke or high-risk TIA.

Milvexian (JNJ-70033093; BMS-986177) is a direct-acting, reversible, high-affinity inhibitor of activated human coagulation Factor XI (Factor XIa or FXIa), a serine protease involved in the intrinsic pathway of the coagulation cascade.

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LIBREXIA Study

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Enrolling during regular work hours (M – F 7am – 5pm)

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TARGET POPULATION

Age 40+

Pre-event mRS 0-2

Ischemic Stroke: NIHSS score ≤ 7 and at least 1 of the following:

• Persistent signs or symptoms of the ischemic event at the time of randomization, OR
• Acute, ischemic brain lesion determined by standard-of-care neuroimaging OR
• Participant underwent thrombolysis or thrombectomy

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TIA: acute onset neurological deficit attributable to focal ischemia by history or examination, with complete symptom resolution of the deficit and no brain infarction on neuroimaging (eg, CT scan or MRI, performed as part of standard medical practice), and ABCD2 Score ≥6

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Major Exclusions:

• Current/prior ICH (HI1 and SAH >1yr ok)
• Cardioembolic/planned a/c,
• High risk of bleeding

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Fellow Responsibilities ~�LIBREXIA�

OUTER LIMITS (8 Hours)�Endovascular Therapy for Large Core Patients with Uncertain Response to Thrombectomy���

PI: Albers, Heit, Lansberg, Coordinator: Irina Eyngorn

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STUDY OVERVIEW

Prospective randomized trial of patients with acute ischemic anterior circulation strokes due to large artery occlusion who present with an eligible large ischemic core lesion, and who can be treated within 8 hrs of stroke onset.

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Patients will be randomized to EVT vs. medical management. The primary endpoint, (mRS) will be assessed at 3 months.

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OUTER LIMITS Study

Enrolling 24/7 (off hours are without coordinator support)

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TARGET POPULATION

• ICA or MCA-M1 Occlusion
• Age 18-90
• Pre-event mRS 0-2 (or patients age >85 years, baseline mRS of 0-1)
• NIHSS score >/= 10
• EVT can be initiated (puncture) w/in ≤8 hrs of stroke onset

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Imaging Criteria:

• Mismatch and Core Lesion Volumes Greater than > 125 mL
• No Mismatch and Core Lesion Volume Greater than 70 mL

Major Exclusions:

• tPA/TNK > 4.5hrs
• Tumor, ICH, sig. mass effect
• Unable to obtain perfusion imaging

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Fellow Responsibilities ~�OUTER LIMITS�

Example introduction to OUTER LIMITS study

You (your spouse / Mother / Father) are/is having a stroke. The stroke is caused by a blood clot that is blocking a large blood vessel in the brain. For some patients we can remove the clot with a device. This is called mechanical clot removal and involves advancing a thin tube into the brain through an artery in the leg. The use of these devices to remove blood clots is cleared by the FDA for patients with small to moderate sized strokes. Recent studies suggest patients with larger strokes can also benefit; however, (your/ your family member’s) stroke is larger than the vast majority of patients enrolled in these studies.

It is not known if the addition of the mechanical clot removal will lead to better recovery from very large strokes. The procedure is associated with a small risk of bleeding in the brain which can potentially make the stroke worse.

If you agree to participate in this study, you will be randomly assigned to undergo either usual medical care by itself or usual medical care and a mechanical clot removal procedure. If you agree to participate there is a 50% chance (you/family member) will receive the clot removal procedure.

If they are interested in participation, then provide the full consent form for signature, which can be sent by email.

Note: If consent in being obtained during transfer, indicate that eligibility for the study will be determined by the brain scan that will be done immediately on arrival. If the consent is signed in advance, we can immediately randomize the patient after the scan results confirm eligibility.

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STEP Low NIHSS�Stroke Net Thrombectomy Endovascular Platform

PI: Heit, Lansberg, Coordinator: Irina Eyngorn

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STUDY OVERVIEW

Randomized, Multifactorial, Adaptive, Registry-leveraged, Platform trial that seeks to optimize the care and optimal treatment strategy of patients with acute ischemic stroke due to large vessel occlusions.

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Patients will be randomized to EVT + medical management vs. medical management alone.

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STEP Low NIHSS Study

Enrolling 24/7 (off hours are without coordinator support)

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TARGET POPULATION

• Complete occlusion (TICI 0) of the intracranial ICA /M1
• Age 18+
• Pre-event mRS 0-2
• Mild presenting neurologic deficits - NIHSS 0-5.
• If NIHSS is 0 then some focal neurological deficit attributable to the location of occlusion should be present
• Presentation to the hospital w/in 24 hours of LKW

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Major Exclusions:

CT ASPECT score <6 or MRI ASPECT score <7

Tumor, ICH, sig. mass effect

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Fellow Responsibilities ~�STEP LOW NIHSS STUDY�

CRISP 2

PI: Maarten Lansberg; Lead Coordinator: Camila

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Study aims:

1. develop methods that identify patients who are most likely to benefit from neuroprotection and

2. develop imaging tools that can be used to assess the effect of neuroprotective treatments.

• LVO (including basilar)
• have MRI/MR perfusion or CT/CT Perfusion as part of routine stroke workup at admission
• are considered for endovascular therapy (endovascular therapy not required for eligibility)

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CRISP 2 Study

Enrolling 24/7 (by fellow)

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TARGET POPULATION

• ≥18 years

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• Have an LVO (including basilar) that is being considered for EVT
• (does not need to go to the cath lab to be eligible)

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• Has undergone a baseline MR/MRA/MRP or CT/CTA/CTP at Stanford or at an outside hospital

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Fellow Responsibilities ~ �CRISP 2�

Example introduction to CRISP 2 study

Short Version (revise wording as appropriate if obtaining consent from surrogate)

Mr./ Mrs. *** we are conducting a research study looking at changes in the brain during a stroke and we would like to ask if you would be willing to participate. If you agree, we will collect brain imaging data and health data from your medical record to use for our analyses. Our hope is that we are able to develop methods to identify patients in the future who are more likely to benefit from protective treatments during a stroke.

There is no direct participation required and there will be no additional tests or treatment added to your care. The only risk of participation is a slight risk of loss of confidentiality. However, we have procedures in place to keep your records safe and secure.

Do you have any questions?

Do you agree to participate? Note that if you agree now, you can always change your mind later. Thank you

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PRECISE �PeRfusion imaging to identify postErior CIrculation candidateS for thrombEctomy

PIs: Albers/Heit; Lead Coordinator: Irina

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Study aim:

To determine if cerebral perfusion imaging can identify a subset of patients who are more likely to have a favorable clinical response following endovascular thrombectomy for the treatment of AIS caused by PC-LVO.

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Target Population:

• Basilar or Vertebral artery occlusion on CTA or MRA
• EVT done as SOC w/in 48 hours of onset
• Age >/= 18
• NIHSS >/= 4 and mRS </=2

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Observational study - consent is not required in the acute setting

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Fellow Responsibilities ~�PRECISE�

Ischemic Brain Damage & Quantum Sodium MRI

Sodium MRI Study: Study Overview

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Observational study to evaluate the role of tissue sodium concentration on the acute management of brain ischemia. This new method may be helpful in assessing the outcomes of potential therapies for acute stroke.

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Primary Objective

To determine if brain tissue with a TSC above 70mM represents non-viable tissue and, therefore, will not recover upon reperfusion therapy of any type in acute stroke subjects.

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Sodium MRI Study

Enrolling 24/7 (off hours are without coordinator support)

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TARGET POPULATION

• >/= 18
• Baseline NIHSS >/= 1
• Undergoing mechanical thrombectomy as part of clinical care
• NO CONTRAINDICATIONS to MRI
• Obtain informed consent prior to clinical MRI

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PROCEDURES

Initial Imaging After Cath Lab

Standard (SOC) post – cath brain MRI ordered+ sodium MRI sequence

• must be done within 6 hours after completion of cath lab.
• After the clinical scan, patient remains in the scanner for an additional 20 minutes of research sodium MRI imaging. No contrast is used for the research scan.

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Day 5 MRI (or discharge, whichever is sooner)

Brain MRI (w/o contrast and w/o MRA)

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Fellow Responsibilities ~ �Sodium MRI study�

StrokeCog In-Patient

PI: Marion Buckwalter; Lead Coordinator: Chastin Chung

OBJECTIVE:

To establish a Stroke Recovery Cohort to advance knowledge about, and aid in therapy development for patients recovering from stroke.  To advance our knowledge of how the immune system affects the process of recovery and specifically how autoimmune processes triggered by stroke contribute to cognitive trajectories.

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• Ischemic or hemorrhagic stroke confirmed on brain imaging  
• Sufficiently fluent in English or Spanish to undergo cognitive assessment 
• Age >/= 18

Fellow Responsibilities ~ �StrokeCog�

cAPPricorn�A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients with CAA��

PI: Chitra Venkat; Lead Coordinator: Chastin Chung

OBJECTIVE:

Study Overview:

The proposed study, ALN-APP-002, is a randomized, double-blind, placebo-controlled, multicenter Phase 2 study designed to evaluate the efficacy, safety, tolerability, and PD of ALN-APP, administered by IT injection in adult patients with CAA.

The primary objective of the study is to evaluate the effect of ALN-APP on the incidence of new lobar CMBs. The primary analysis will be conducted after all patients in the sCAA cohort have completed the Month 18 assessments. Patients will also be assessed through Month 24 to enable additional efficacy and safety evaluations during the placebo-controlled double-blind treatment period. Patients may then choose to receive ALN-APP in an optional OLE period of up to 18 months through Month 42. Patients who complete the double-blind treatment period and the optional OLE period will be followed for a total of 48 months

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cAPPricorn Study

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TARGET POPULATION

• CAA (Dutchtype or Sporadic)

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• Age criteria:
• Dutch Type >/= 30
• Sporadic >/= 50

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• sCAA must have prior medical history of spontaneous ICH

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Major Exclusion

Moderate or Severe Stage AD (defined as global clinical

dementia rating [CDR] 2.0 or 3.0, respectively)

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Fellow Responsibilities ~ �cAPPricorn�

ASPIRE

Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery

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Fellow Responsibilities ~ �ASPIRE study�

SATURN�Statins Use in Intracerebral Hemorrhage Patients�

Fellow Responsibilities ~�SATURN study� Enrolling during regular work hours (M – F 7am – 5pm)��

BOOST-3 �Brain Oxygen Optimization in Severe TBI

PI: Karen Hirsch, Coordinator: Elizabeth Osborn

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DIAGNOSIS: Traumatic Brain Injury (TBI)

STUDY OVERVIEW:

BOOST3 is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU). The study will determine the safety and efficacy of a strategy guided by treatment goals based on both intracranial pressure (ICP) and brain tissue oxygen (PbtO2) as compared to a strategy guided by treatment goals based on ICP monitoring alone.

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• Glasgow Coma Score (GCS) of 3–8 (off paralytics)
• Evidence of intracranial trauma on a head CT scan
• The decision to place the intracranial monitors within 6 hours of arrival at Stanford, but no later than 12 hours after injury
• Age >/=14 years

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*EFIC study: If LAR cannot be reached participant can be randomized under EFIC after probes have been placed.

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BOOST-3 Interventions

• The physiological intervention protocol is a set of interventions to reduce secondary brain injury in the first 5 days (120 hours)after injury or until the participant awakens from coma (motor GCS = 6)
• The protocol is tiered in a hierarchical fashion, with less aggressive interventions attempted before more aggressive maneuvers. 
• The control group will receive standard care (based on ICP driven interventions alone), while the treatment group will be managed using information from the ICP monitors as well as from the PbtO₂ monitors
• The designated study Moberg will alarm to indicate an intervention is needed and is also used by the beside nurse to document each intervention.

Fellow Responsibilities ~ �BOOST-3 Study� Enrolling 24/7

POST-ICECAP�Patterns Of Survivors’ Recovery Trajectories in the ICECAP Trial

PI: Karen Hirsch, MD / Coordinator: Arely/Elizabeth

DIAGNOSIS: Out of Hospital Cardiac Arrest

POST-ICECAP is a multicenter observational study that investigates the long-term recovery trajectories of out-of-hospital cardiac arrest (OHCA) survivors. The study consists of five visits over the 12-month period following OHCA to assess changes in functional, cognitive and quality of life outcomes.

• Age >/=18 years
• Coma after resuscitation from out of hospital cardiac arrest
• Must have received TTM
• Must have survived OHCA for at least 30 days
• Must be English or Spanish speaking

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Fellow Responsibilities ~ �POST-ICECAP�

CIRCA Chronotype & Stroke Registry

PI: Greg Albers, MD / Coordinator: Cindy Kim

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DIAGNOSIS: Acute Ischemic Stroke or TIA

OBJECTIVE: The goal of this study is to determine how an individual's natural sleep patterns, known as their "chronotype," affect the course of stroke and stroke treatment.

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• Presented to the hospital within 24 hours of last known well
• Age >/=18 years

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Fellow Responsibilities ~ �CIRCA�