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Stroke Research


Arteriovenous Malformation (AVM)


bAVM

Purpose: Human Brain Arteriovenous Malformation (bAVM) Molecular Analysis; EndMT as a Target to Treat Human Brain Arteriovenous Malformations.

Principal Investigator: Ping R Chen, MD

Lead CRC: Eddie Aguilar

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Stroke Prevention Trials


CAPTIVA – Comparison of Anti-Coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis

Investigator: Anjail Sharrief, MD, MPH, FAHA

Lead CR: Ariana Aquino Hernandez

The purpose of this study is to directly compare novel antithrombotic medications to standard care antiplatelet medications for preventing stroke and death from vascular causes in patients with narrowed brain arteries

Enrollment Status: Actively enrolling

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Librexia

Purpose: A 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.

Principal Investigator: Robert J Brown, MD

Lead CRC: Kaitlin Simmons

NCT#: 05702034

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SATURN: StATins Use in intRacerebral hemorrhage patieNts

Investigator: Chen, Jared

Lead CRC: Kristina Ramirez

Purpose: determine the effects of continuation vs. discontinuation of statins on the risk of ICH recurrence

Key Inclusion Criteria: Patients presenting with a spontaneous lobar lCH while taking a statin drug

Enrollment Status: Actively enrolling

NCT#: 03936361

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START – Optimal Delay Time to Initiate Anticoagulation after Ischemic Stroke in Atrial Fibrillation

Investigator: Abdelhamid, Noureldin

Lead CR: Cooksey, Gabretta

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Video-Based Intervention to Reduce Treatment and Outcome Disparities in Adults Living with Stroke or Transient Ischemic Attack (VIRTUAL)

Investigator: Anjail Sharrief, MD, MPH, FAHA

Lead CR: Caitlynn Carter

The purpose of this study is to address the medical and social needs of patients, while providing them with the technology to engage in telehealth intervention. It will provide understanding on the impact of intervention on key clinical outcomes relative to standard care.

Enrollment Status: Actively enrolling

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SLEEP SMART – Sleep for Stroke Management and Recovery Trial

Investigator: Anjail Sharrief, MD, MPH, FAHA

Lead CR: Ariana Aquino Hernandez

The primary goals of this study are to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality during 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced in ischemic stroke.

Enrollment Status: Actively enrolling

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REACH-ICH – Race/Ethnicity, Hypertension, and Prevention of VCID After Intracerebral Hemorrhage

Investigator: Anjail Sharrief, MD, MPH, FAHA

Lead CR: Mariel Flake-Rojas

The goal of this study is to determine whether modifiable SDOH predict risk of poor hypertension control after ICH thorugh BP monitoring.

Enrollment Status: Actively enrolling

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STOP STROKE – Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction

Investigator: Sharrief, Anjail

Lead CR: Cooksey, Gabretta

Ischemic and hemorrhagic stroke.

Enrollment Status: Actively enrolling

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WVACHII obs – Registry for Women’s Vascular and Cardiac Health Interdisciplinary Initiative

Investigator: Gonzales, Nicole R

Lead CR: Tulod, Kathleen B

Enrollment Status: Actively enrolling

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Recovery Trials

Digital Biomarkers For Vascular Cognitive Decline in Patients with Minor Stroke (MARSH-MEG Cognition)

Investigator: Anjail Sharrief, MD, MPH, FAHA

Lead CR: Ariana Aquino Hernandez

The goals of this study are to identify common patterns of functional brain network disruption and to determine the compensatory changes in functional brain networks over time that allow for improvement and assess early functional network alterations.

Enrollment Status: Actively enrolling

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REDUCE – Spironolactone for Blood Pressure Control After Intracerebral Hemorrhage

Investigator: Anjail Sharrief, MD, MPH, FAHA

Lead CR: Mariel Flake-Rojas

The purpose of this study is to compare the effect of spironolactone-containing antihypertensive regimens versus standard antihypertensive regimens on 3-months change in home systolic BP in stroke survivors.

Enrollment Status: Actively enrolling

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MicroRNAs, Mitochondria and the Blood-Brain Barrier – Therapeutic Targets for Stroke

Investigator: Xuefang Ren, MD, PhD

Purpose: The objective of this proposal is to investigate if endothelial specific miR-34a affects stroke outcomes in the aged brain. We hypothesize that endothelial miR-34a regulates BBB permeability, ischemic damage, hemorrhagic transformation, and stroke-induced deficits by inhibiting translation of LETM1 and LETMD1 leading to impaired mitochondrial bioenergetics in CECs.

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PREDICT – ICH obs – Predicting Upper Extremity Motor Recovery in Subcortical Hemorrhagic Stroke Using DTI and TMS

Investigator: Sean Savitz, MD (Zafer/Shayan/Aronowski)

Lead CRC: Dorothea Parker

Diagnostics TMS in ICH

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LAPHI obs – Lesion size and Brain Atrophy changes in Patients with Hemorrhagic and Ischemic Stroke (LAPHI)

Investigator: Muhammad Haque, MD

Lead CRC: George, Sarah

Summary Assessment of MRI after stroke

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TRANSPORT-2 – TRANScranial direct current stimulation for Post-stroke motor Recovery – a phase II study

Investigator: Gerard Francisco, MD

Lead CRC: Parker, Dorothea M

Purpose: Upper extremity recovery after ischemic stroke

Key Inclusion Criteria: 1st ever, unilateral ischemic stroke; at least 10 degrees of wrist extension

tDCS+CIMT for with 6 months of 1st ever, unihemispheric AIS.

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PISCES – A Randomized, Placebo-Controlled Study of the Efficacy and Safety of Intracerebral Stem Cells (CTX0E03 DP) in subjects with Disability Following an Ischemic Stroke

Investigator: Savitz, Sean I

Lead CRC: Dorothea Parker

Purpose: Motor recovery

Key Inclusion Criteria: ischemic stroke, wrist extension and shoulder shrug present

Enrollment Status: Actively enrolling
Summary IV Stem cell therapy for chronic IS

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iACQUIRE – Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation

Investigator: Nivedita Thakur, MD

Lead CRC: Dorothea Parker

Purpose: Recovery of upper extremity weakness in neonatal stroke

Key Inclusion Criteria: 8-36 months with unilateral upper extremity deficit

In-home CIMT in chronic pediatric AIS.

Enrollment Status: Actively enrolling

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Study Name VAST-rehab (Obs) – Virtually Assisted home rehabilitation after Acute Stroke

Investigator: Sean Savitz, MD

Lead CRC: Dorothea Parker

Summary Home-based telerehab after acute stroke (AIS / ICH)

Enrollment Status: On hold

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COPOR Obs Clinical Outcome and Patient Factors in Patient’s outcomes admitted to inpatient rehabilitation facility

Investigator: Sean Savitz, MD

Lead CRC: Dorothea Parker

Purpose: Evaluating the effect of IPR on stroke recovery

Key Inclusion Criteria: admitted to IPR facility within MH system

Retrospective analysis of inpatient rehab and recovery data

Enrollment Status: Actively enrolling

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NCS-01

Investigator: Anjail Sharrief, MD

Lead CRC: Dorothea Parker

Purpose: Recovery

Key Inclusion Criteria: Ischemic stroke; NIHSS 6-18 w/ or w/o TPA/IAT (maintains score after intervention); pre-stroke mRS <3; LSN < 32 hours from planned infusion

Assesses regional patterns of care for ICH

Enrollment Status: Actively enrolling

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BIONICS

Investigator: Sean Savitz, MD

Lead CRC: Dorothea Parker

Purpose: Machine learning

Key Inclusion Criteria: Cleared to participate in rehab activity

Enrollment Status: Actively enrolling

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Acute Ischemic Stroke (AIS)


Millipede AspiRation for Revascularization in Stroke (MARRS) Study

Purpose: The objectives of the study are to examine the performance and safety characteristics of the Millipede System when used for revascularization of patients with acute ischemic stroke due to Large Vessel Occlusions (LVOs) and to record associated clinical outcomes.

Investigator: Michael Nahhas, MD

Lead CRC: Joseph Samaha

Enrollment Status: Actively Enrolling

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Intrepid – Impact of Fever Prevention in Brain Injured Patients

Investigator: HuiMahn Alex Choi, MD

Lead CRC: Glenda L Torres

IS, ICH, SAH

Enrollment Status: Actively Enrolling

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Stroke (AIS) Bio-Repository

Investigator: Aronowski, J

Lead CRC: Satani, Nikunj

Biorepository of specimens including blood, CSF and brain tissue

Enrollment Status: Actively Enrolling

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SPLENDID

Purpose: Safety, Performance and Lesion Evaluation of Neurothrombectomy using CEREGLIDE 92 Intermediate Catheter: A Prospective Multi-Center Single-Arm IDE Trial

Principal Investigator: Ping R Chen, MD

Lead CRC: Eddie Aguilar

Enrollment status: Upcoming

NCT#: 06386289

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Acute Brain Hemorrhage Trials


Andexanet-Alpha

Purpose: Early administration and treatment of factor Xa related intracranial hemorrhage on a Mobile Stroke Unit: A prospective pilot feasibility study.

Principal Investigator: Ritvij Bowry, MD

Lead CRC: Glenda Torres.


BEACH

Purpose: Biomarker and Edema Attenuation in IntraCerebral Hemorrhage.

Principal Investigator: Tiffany Chang, MD

Lead CRC: Glenda Torres

NCT#: 05020535


FASTEST (start up pending) – Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial

Investigator: James Grotta

Lead CR: Bratina, Patti L

Enrollment Status: Actively Enrolling

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Novartis

Investigator: HuiMahn Alex Choi, MD

Lead CRC: Glenda Torres

Enrollment Status: Actively Enrolling

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Intrepid – Impact of Fever Prevention in Brain Injured Patients

Investigator: HuiMahn Alex Choi, MD

Lead CRC: Torres, Glenda L

AIS, ICH, SAH

Enrollment Status: Actively Enrolling

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CAA-ICH – Developing a Biochemical Test to Differentiate Cerebral Amyloid Angiopathy-Intracerebral Hemorrhage from Hypertensive Hemorrhage (obs)

Investigator: Gonzales, Nicole R

Lead CRC: Kathleen Tulod

Enrollment Status: Actively Enrolling

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Hemostasis obs

Investigator: Chang, Tiffany R

Lead CRC: Torres, Glenda L

Enrollment Status: Actively Enrolling

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Subarachnoid Hemorrhage Trials


Intrepid – Impact of Fever Prevention in Brain Injured Patients

Investigator: HuiMahn Alex Choi

Lead CR: Glenda L Torres

Enrollment Status: Actively Enrolling

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Mani bio-Repository

Investigators: Huimahn Alex Choi/Tiffany Chang

Lead CR: Glenda L Torres

Enrollment Status: Actively Enrolling

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Chronic Subdural Hematoma Treatment with Embolization Versus Surgery Study (CHESS)

Investigator:Sunil Sheth, MD

Lead CR: Joseph Samaha

Safety and efficacy of Middle meningeal artery embolization compared to conventional surgery for moderately symptomatic convexity chronic subdural hematoma (CSDH)

Enrollment Status: Enrolling soon

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Millipede AspiRation for Revascularization in Stroke Study (MARRS)

Investigator: Michael Nahhas, MD

Lead CR: Joseph Samaha

The objectives of the study are to examine the performance and safety characteristics of the Millipede System when used for revascularization of patients with acute ischemic stroke due to Large Vessel Occlusions (LVOs) and to record associated clinical outcomes.

Enrollment Status: Actively enrolling

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STRATEGY FOR IMPROVING STROKE TREATMENT RESPONSE TRIAL (SISTER)

Investigator: Andrew Barreto, MD

Lead CR: Prasen Marella

To identify a dose of TS23 (monoclonal antibody against alpha-2 anti-plasmin) that is safe and more efficacious than placebo for the treatment of patients from 4.5 to 24 hours of ischemic stroke onset (or last known well), who have evidence of core-penumbra mismatch on perfusion imaging and are not a candidate for standard of care reperfusion therapies

Enrollment Status: Actively enrolling

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ReMEDy2 Trial

Investigator: Andrew Barreto, MD

Lead CR: Prasen Marella

Phase 2/3 Adaptive Design, Randomized Double-blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of DM199( Recombinant human tissue kallikrein-1) for the Treatment of acute ischemic stroke presenting within 24 hrs. of last seen normal or symptom onset.

Enrollment Status: Actively enrolling

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

Investigator: Andrew Barreto, MD

Lead CR: Prasen Marella

To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation. To determine if apixaban, compared to aspirin, results in better functional outcomes as measured by the modified Rankin scale

Enrollment Status: Actively enrolling

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Clinical Trials

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