RESEARCH GRANTS:
Federal
Funding Agency: StrokeNet
Title: Anticoagulation for Stroke Prevention and Recovery After ICH (ASPIRE)
Status: Active
Period: 11/2019 - 04/2024
Role: Co-Investigator
Grant Detail: ASPIRE is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH and high-risk non-valvular AF (CHA2DS2-VASc score ≥ 2). Seven hundred patients will be enrolled over 3.5 years and followed for study outcomes for a minimum of 12 months and maximum of 36 months. The primary efficacy outcome is any stroke (hemorrhagic or ischemic) or death from any cause. The secondary efficacy outcome is the change in the modified Rankin Scale score. Recruitment will take place at sites coordinated through the NIH/NINDS StrokeNet.
Funding Agency: National Institute of Neurological Disorders and Stroke (NINDS)
Title: AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke
Status: Active
Period: 01/2018 - Present
Role: Co-Investigator
Grant Detail: ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at 120 sites in the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.
Funding Agency: National Institute of Health
Title: Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH)
Status: Active
Period: 07/2010 - 07/2017
Role: Principal Investigator
Grant Detail: The goal of this study is to identify differences in risk factor distribution, imaging characteristics, and outcomes in a multi-center case control study of intracerebral hemorrhage.
Private
Funding Agency: GENENTECH
Title: A PHASE III, PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF THROMBOLYSIS IN IMAGING-ELIGIBLE, LATE-WINDOW PATIENTS TO ASSESS THE EFFICACY AND SAFETY OF TENECTEPLASE (TIMELESS)
Status: Active
Period: 06/2019 - Present
Role: Co-Principal Investigator
Grant Detail: This study will evaluate the efficacy and safety of tenecteplase compared with placebo in patients with acute ischemic stroke (AIS). All patients will receive standard-of-care therapy according to American Heart Association / American Stroke Association clinical guidelines (2018). To determine eligibility for randomization, all patients will undergo multimodal CT or MRI at baseline. Only patients with a vessel occlusion (ICA or MCA) and penumbral tissue will be randomized.
The primary analysis is to compare the efficacy of tenecteplase versus placebo in all patients at Day 90.
Funding Agency: ReNeuron Limited
Title: A Randomized, Placebo-Controlled Study of the Efficacy and Safety of Intracerebral Stem Cells (CTX0E03) in Subjects With Disability Following an Ischemic Stroke
Status: Active
Period: 04/2019 - 06/2020
Role: Co-Investigator
Grant Detail: This is a randomized, placebo-controlled, multi-center study. Patients with persistent disability 6-12 months following an ischemic stroke will be enrolled following confirmation of eligibility. Patients will be randomized 1:1 to undergo a stereotactic surgery and receive a single administration of CTX0E03 Drug Product by intracerebral implantation or undergo sham surgery only (placebo). Patients will be followed for 12 months after surgery with follow-up assessments occurring at various time points over the 12 months. All eligible patients will be assigned a standardized Physical Therapy (PT) program. Patients will complete their daily PT exercises at home for 12 weeks after their surgery.
Funding Agency: Bayer HealthCare
Title: NAVIGATE ESUS: Secondary prevention of stroke in patients with Embolic Stroke of Undetermined Source
Status: Active
Period: 01/2015 - Present
Role: Principal Investigator
Grant Detail: Multicenter, randomized, double-blind, double-dummy, active-comparator, event-driven, superiority phase III study of secondary prevention of stroke and prevention of systemic embolism in patients with a recent Embolic Stroke of Undetermined Source (ESUS), comparing rivaroxaban 15 mg once daily with aspirin 100 mg (NAVIGATE ESUS)
Funding Agency: CEREVAST THERAPEUTICS
Title: Phase 3, Randomized, Placebo-Controlled, Double-Blinded Trial of the Combined Lysis of Thrombus With Ultrasound and Systemic Tissue Plasminogen Activator (tPA) for Emergent Revascularization in Acute Ischemic Stroke (CLOTBUST-ER)
Status: Complete
Period: 05/2014 - 02/2015
Role: Co-Investigator
Grant Detail: Phase 3 clinical trial evaluating the use of the company’s proprietary Clotbust ER™ ultrasonic headframe for the treatment of acute ischemic stroke. This worldwide study intends to enroll up to 800 ischemic stroke patients in a randomized, double-blinded clinical trial designed to evaluate the efficacy and safety of the Clotbust ER™ ultrasound device when used in combination with standard intravenous thrombolytic therapy.
Funding Agency: Edwards Lifesciences Corp
Title: The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII A (PARTNERII A)
Status: Active
Period: 09/2012 - 01/2029
Role: Contributor
Grant Detail: The safety and effectiveness of the SAPIEN XT transcatheter heart valve with novaflex ASCENDRA/ASCENDRA II Delivery systems in intermediate risk for aortic valve surgery and patients who cannot undergo surgery
Funding Agency: American Nurses‘ Foundation
Title: Toward a Better Understanding of Readmissions for Elderly Stroke Survivors
Status: Complete
Period: 09/2011 - 08/2013
Role: Co-Investigator
Grant Detail: The purpose of this mixed-methods study is to identify patient/caregiver and health care system factors that are associated with readmission for older adult stroke survivors in the initial 6 months following a stroke. Through a better appreciation of the factors associated with readmission, including the perspectives of both the stroke survivor and family caregiver and how the current system of care is addressing their needs, we will be positioned to implement and evaluate changes to the system of care to improve outcomes for older adults with stroke and their families.
Funding Agency: Penumbra
Title: Imaging Guided Patient Selection for Interventional Revascularization Therapy (START)
Status: Complete
Period: 07/2010 - 07/2011
Role: Principal Investigator
Grant Detail: Clinical Outcome in Acute Stroke Treatment after Imaging Guided Patient Selection for Interventional Revascularization Therapy. The objective of this clinical evaluation is to determine the safety and effectiveness of the Penumbra System in a stroke cohort who presents within eight hours from symptom onset and witha know core infarct volume at admission.State
Funding Agency: Lone Star Stroke Research Consortium / Texas Department of State Health Services
Title: Optimal Delay Time to Initiate Anticoagulation after Ischemic Stroke in Atrial Fibrillation (START): a pragmatic, adaptive randomized clinical trial.
Status: Active
Period: 01/2019 - Present
Role: Co-Investigator
Grant Detail: Long-term oral anticoagulation is standard for secondary stroke prevention in patients with atrial fibrillation (AFib). However, there is limited data and no consensus on the timing of when to initiate anticoagulation therapy, and concern that starting too soon risks symptomatic hemorrhagic transformation. These data are derived almost exclusively from heparins and Vitamin K antagonists (e.g.,warfarin). Now that NOACs have become the mainstay of stroke prophylaxis in AFib and have more rapid and consistent anticoagulation and fewer strokes (hemorrhagic especially), the question of optimal timing of NOAC initiation is of increasing importance.
The primary aim is to determine the time-to-treatment interval with the lowest associated risk for adverse events in the context of anticoagulation therapy with NOACs for acute stroke patients with non-valvular AFib. The question will be investigated with a prospective, adaptive, randomized, controlled "dose-exploration" trial with the time to treatment with NOAC therapy treated as the incremental "dose".
Funding Agency: Lone Star Stroke Research Consortium / Texas Department of State Health Services
Title: Intra-arterial Transfer Time Metric Study (IA-TIMES)
Status: Complete
Period: 01/2017 - 06/2019
Role: Co-Investigator
Grant Detail: This study will help establish protocols to optimize processes that will accelerate the transfer of these patients in order to receive treatment faster. We, therefore, aim to describe the current landscape of IAT transfer times at Texas CSCs/IAT-capable stroke centers to identify barriers/delays in the transfer process (phase 1). We then seek to develop best practices to optimize the transfer of patients destined for IAT (phase 2)
Funding Agency: Lone Star Stroke Consortium
Title: Nursing-driven Acute Stroke Care (NAS-Care)
Status: Complete
Period: 03/2016 - 01/2018
Role: Co-Investigator
Grant Detail: NAS-Care is a quality improvement Lone Star Stroke (LSS) study that aims to determine the effect of nursing-driven stroke protocols in telestroke hospitals. The goal of NAS-Care is to empower emergency department (ED) nurses to be engaged leaders in the stroke code process. Part of this empowerment involves the nursing staff activating stroke codes, performing standing orders, and working in parallel to quickly and efficiently accomplish a common goal – to gather all information needed to make a tP-A decision as quickly as possible.
Funding Agency: Lone Star Stroke Research Consortium / Texas Department of State Health Services
Title: Efficient Resource Utilization for Patients with Intra-Cerebral Hemorrhage (EnRICH)
Status: Active
Period: 01/2016 - Present
Role: Co-Investigator
Grant Detail: The EnRICH study is enrolling ICH patients across four large metropolitan areas in Texas. Patients are enrolled from large treatment centers and community hospitals and are followed for long-term outcomes. These data will provide evidence regarding the potential benefit to ICH patients from being managed at a higher level of care (i.e. large stroke treatment centers across the state of Texas). Aspects of ICH care that influence long-term functional and cognitive outcomes are also being studied. In doing so, the study will help guide the development of protocols for optimal management of patients with ICH at hospitals with different levels of care.
Funding Agency: Lone Star Stroke Research Consortium / Texas Department of State Health Services
Title: Lone Star Stroke TeleStroke Registry (LESTER)
Status: Active
Period: 09/2015 - Present
Role: Co-Investigator
Grant Detail: LESTER is a telestroke registry that is the first of its kind to seek to understand how stroke care is delivered and how outcomes are achieved with the use of telemedicine in the state. A web-based registry is implemented at sites where a telestroke service is active and primarily involves a stroke coordinator or primary contact who sends a short monthly report on discharge information of admitted stroke patients seen over telemedicine. This will help understand the patterns, mechanisms, and impact of regional stroke care in the context of expanding the telestroke network in the state of Texas.
Funding Agency: School of Nursing - Dean‘s Catalyst Award
Title: A User-Centered Design Approach to the Development and Feasibility Testing of a Multimodal Mobile Intervention for Stroke Survivors and their Family Caregivers
Status: Complete
Period: 06/2013 - 12/2015
Role: Co-Investigator
Grant Detail: Purpose/Objectives: The purpose of this pilot study was to develop and test the feasibility of a multimodal mobile intervention for blood pressure control, targeting underserved stroke survivors and their caregivers. Our long-term goal is to improve blood pressure control in persons at risk for recurrent stroke.
