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    Stroke / TIA Clinical Trials

    Sutter Health participates in clinical trials related to Stroke and TIA throughout their Northern California facilities. See the listing below for an overview of current trials, including contact information. For some trials, more detailed information can be found via the title link to ClinicalTrials.gov.

    Alta Bates Summit Medical Center

    Title: A Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets for Treatment of Stable Walking Deficits in Post-Ischemic Stroke (MILESTONE)
    Description: The primary objective is to determine the effect of two dose strengths of dalfampridine-ER tablets, taken twice daily for 12 weeks, on stable-walking deficites in subjects with post-ischemic stroke.
    Investigator: Joanna Cooper, MD
    Eligibility: Patients 18 and older with stable walking deficit due to ischemic stroke that occurred six months prior or more, with BMI 18-35 kg/m2
    Status: Active and enrolling
    Location: Alta Bates Summit Medical Center
    Contact: Myesha Kirk, 510-204-1609
    Email: kirkjum@sutterhealth.org

    California Pacific Medical Center

    Title: IDEAS - Imaging Dementia - Evidence for Amyloid Scanning
    Description: This study will assess the impact of obtaining results to amyloid PET scans on patient outcomes under Coverage with Evidence (CED) in patients with mild cognitive impairment or dementia of unknown etiology. It is hypothesised is that results to amyloid PET scans will increase confidence in the underlying cause of cognitive impairment which will translate into interventions that lead to improved patient outcomes.
    Investigators: Alireza Atri, MD, PhD
    Eligibility: Participants will be eligible if they are over the age of 65 and there is diagnostic uncertainty about the cause of their cognitive impairment (mild cognitive impairment or dementia) even after a comprehensive clinical evaluation by a dementia expert including laboratory tests (complete blood count, comprehensive metabolic panel, thyroid function tests and vitamin B12 level) and structural brain imaging (CT or MRI).
    Status: Active and open to enrollment
    Location: California Pacific Medical Center
    Contact: Amber Lee, 415-600-5568
    Email: LeeAJ@sutterhealth.org

    Title: Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Lu AE58054 in Patients With Mild-moderate Alzheimer’s Disease Treated With an Acetylcholinesterase Inhibitor (STARBRIGHT)
    Description: This study will assess whether an investigation drug (idalopirdine), given in addition to a current medicaiton (donepezil, rivastigmine, or galantamine) can improve cognitive function in patients with mild to moderate Alzheimer's Disease when compared to placebo and an an acetylcholinesterase inhibitor.
    Investigators: Alireza Atri, MD, PhD
    Eligibility: Participants will be eligible if they are 50 years or older, have a diagnosis of mild to moderate Probable Alzheimer's Disease, are on stable dose of an acetylcholinesterase inhibitor, are NOT taking Memantine, and have a reliable caregiver willing to accompany them to all study visits.
    Status: Active and open to enrollment
    Location: California Pacific Medical Center
    Contact: Amber Lee, 415-600-5568
    Email: LeeAJ@sutterhealth.org

    Title: 18F-AV-1451 Tau PET Imaging Study
    Description: This study will assess the relationship between ante-mortem 18F-AV-1451 Positron Emission Tomography (PET) imaging and tau neurofibrillary pathology associated with Alzheimer's disease, as measured at autopsy.
    Investigators: Alireza Atri, MD, PhD
    Eligibility: Participants will be eligible if they are 50 years or older, who have a projected life expectancy of ≤ 6 months, can tolerate a 20 minute PET scan, and are willing to donate their brain at death for autopsy to compare with PET scan findings. We are seeking participants with normal cognition as well as Mild Cognitive Impairment or Dementia.
    Status: Active and open to enrollment
    Location: California Pacific Medical Center
    Contact: Amber Lee, 415-600-5568
    Email: LeeAJ@sutterhealth.org

    Title: Diffusion Weighted Imaging (DWI) or Computerized Tomography Perfusion (CTP) Assessment With Clinical Mismatch in the Triage of Wake Up and Late Presenting Strokes Undergoing Neurointervention (DAWN Study)
    Description: The purpose of the study is to evaluate the hypothesis that Trevo thrombectomy plus medical management leads to superior clinical outcomes at 90 days as compared to medical management alone in appropriately selected subjects experiencing an acute ischemic stroke when treatment is initiated within 6-24 hours after last seen well.
    Investigators: Nobl Barazangi, MD, PhD and Joey English, MD (co-PIs)
    Eligibility: Subjects 18 years of age and older with clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke
    Status: Active and open to enrollment
    Location: California Pacific Medical Center
    Contact: Douglas Raggett, 415-600-3777
    Email: RaggettD@cpmcri.org

    Title: Reversal of Dabigatran Anticoagulant Effect With Idarucizumab (RE-VERSE AD)
    Description: The purpose of the study is to evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.
    Investigator: Nobl Barazangi, MD, PhD
    Eligibility: 18 yrs or older and currently taking dabigatran etexilate (pradaxa) with either: Overt bleeding judged by the physician to require a reversal agent OR who may not be bleeding, but does require an emergency surgery or invasive procedure for a condition other than bleeding. Emergency is defined as within the following 8 hours.
    Status: Active and open to enrollment
    Location: California Pacific Medical Center
    Contact: Katie Ponting, 415-600-1163
    Email: PontinK@sutterhealth.org

    Title: Stryker Neurovascular Trevo® Retriever Registry
    Description: The purpose of the Trevo® Retriever Registry is to collect real world performance data of the Trevo Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
    Investigator: Joey English, MD
    Eligibility: Subjects experiencing acute ischemic stroke who are eligible for restoration of blood flow using any approved Trevo Retriever in the neurovasculature to remove thrombus
    Status: Active and open to enrollment
    Location: California Pacific Medical Center
    Contact: Wilson Ling, 415-600-3148
    Email: LingW@cpmcri.org

    Title: A Phase 2 Double Blinded, Randomized, Placebo Controlled Dose Escalation Study to Evaluate the Efficacy and the Safety of GM602 in Patients With Acute Middle Cerebral Artery Ischemic Stroke Within an 18-hour Treatment Window
    Description: Efficacy and Safety Study of GM602 in Patients With Acute Middle Cerebral Artery Ischemic Stroke Within 18 Hours (GMAIS).
    Investigator: Nobl Barazangi, MD, PhD
    Eligibility: Subjects with Acute Middle Cerebral Artery Ischemic Stroke who can be treated within an 18-hour treatment window
    Status: Active and open to enrollment
    Location: California Pacific Medical Center
    Contact: Katie Ponting, 415-600-1163
    Email: PontinK@sutterhealth.org

    Title: IV Thrombolysis in Anticoagulated Acute Stroke Patients
    Description: Retrospective study of outcomes and safety of patients who receive off-label IV rt-PA despite full anticoagulation
    Investigator: Nobl Barazangi, MD, PhD
    Eligibility: Retrospective
    Status: Active and open to enrollment
    Location: California Pacific Medical Center
    Contact: Katie Ponting, 415-600-1163
    Email: kpontin@sutterhealth.org

    Title: Expanding the Time Window for IV Thrombolysis with rt-PA in Acute Ischemic Stroke Patients Using Computed Tomography Perfusion Imaging: The PERFusion Use in Stroke Evaluation (PERFUSE) Study (Sutter Pacific Medical Foundation)
    Description: A phase II trial, evaluating the utility of 64 slice CT perfusion (CTP) in acute ischemic stroke (AIS) patients. The main aim is to determine which aspects of CTP imaging can aid in expanding the time window for thrombolysis with IV (rt-PA) in AIS patients up to 6 hours after symptom onset.
    Investigator: Nobl Barazangi, MD, PhD
    Eligibility: Active ischemic stroke within 6 hours of symptom onset received IV rt-PA and have CT perfusion imaging
    Status: Active and open to enrollment
    Location: California Pacific Medical Center
    Contact: Katie Ponting, 415-600-1163
    Email: kpontin@sutterhealth.org

    Title: Platelet- Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial
    Description: A prospective randomized double-blind multicenter trial; the primary objective is to determine whether clopidogrel 75mg/day bu mouth after loading dose of 600mg of clopidogrel is effective in preventing major ischemic vascular events ischemic stroke, myocardial infarction, and ischemic vascular death) at 90 days when initiated within 12 hours of TIA or minor ischemic stroke onset in patients receiving aspirin 50-325 mg/day.
    Investigator: Nobl Barazangi, MD.
    Eligibility: TIA or minor stroke; must be enrolled within 12 hours of symptom onset.
    Status: Active and open to enrollment
    Location: California Pacific Medical Center
    Contact: Katie Ponting 415-600-1163
    Email: PontinK@cpmcri.org

    Title: The S.M.A.R.T. Approach to Stroke Treatment
    Description: To evaluate, retrospectively, CPMC's Comprehensive Stroke Care Center's experience with the Simplified Management of Acute stroke using Revised Treatment criteria (SMART) approach towards treating stroke patients
    Investigator: David Tong, MD
    Eligibility: Retrospective study of all stroke patients treated at CPMC, especially those receiving acute stroke therapy
    Status: Active and open to enrollment
    Location: California Pacific Medical Center
    Contact: Katie Ponting, 415-600-1163
    Email: PontinK@cpmri.org

    Title: COMPASS Trial: a Direct Aspiration First Pass Technique
    Description: This is a prospective, randomized trial comparing mechanical thrombectomy with the ADAPT approach to stent retrievers in patients presenting with AIS within 6 hours of symptom onset.
    Investigator: Joey English, MD
    Eligibility: Subjects, 18 y/o and older, with acute ischemic stroke, NIHSS ≥8 at the time of neuroimaging and persistent symptoms within 6 hours of when groin puncture can be obtained
    Status: Coming soon
    Location: California Pacific Medical Center
    Contact: Douglas Raggett, 415-600-3777
    Email: RaggettD@cpmcri.org

    Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled 21-Day Treatment Study, Including an fMRI Sub-Study, to Evaluate the Effect of HT-3951 on Upper Extremity Motor Function Following Ischemic Stroke (RESTORE)
    Description: This is a randomized, double-blind, placebo-controlled parallel group outpatient study that will utilize standard stroke rehabilitation outcome measures, as well as fMRI techniques in a subset of subjects, to evaluate the effect of HT-3951 on motor recovery and behavior in medically stable subjects following ischemic stroke.
    Investigator: Scott Rome, MD
    Eligibility: Subjects, 40 to 85 y/o, who have experienced an ischemic stroke documented by CT or MRI with size of the lesion ≤ 60 cc resulting in an upper extremity deficit that, in the opinion of the Investigator, warrants the need for rehabilitation therapy
    Status: Coming soon
    Location: California Pacific Medical Center
    Contact: Douglas Raggett, 415-600-3777
    Email: RaggettD@cpmcri.org

    Eden Medical Center

    Title: WEAVE
    Description: WEAVE Trial: Wingspan Stent System Post Market Surveillance Study. The primary objective of this study is to evaluate the rate of stroke and death in patients treated with the Wingspan Sten Sustem, according to the indications for use, within 72 hours post procedure.
    Investigator: David Bonovich, MD
    Eligibility: All patients for whom treatment with the Wingspan Stent System is considered.
    Status: Active and open to enrollment
    Location: Eden Medical Center
    Contact: Catherine Ndungu-Case, 510-727-8267
    Email: ndunguc@sutterhealth.org

    Title: PROSPER - Patient-centered Research into Outcomes Stroke patients Prefer and Effectiveness Research
    Description: PROPER is a three year research project to create a national, sustainable model to improve decision-making and patient-centered stroke outcomes through comparative effectiveness research.
    Investigator: David Bonovich, MD
    Eligibility: Patients ≥18 and with a primary diagnosis of acute ischemic stroke.
    Status: Active and open to enrollment
    Location: Eden Medical Center
    Contact: Catherine Ndungu-Case, (510) 727-8267
    Email: ndunguc@sutterhealth.org

    Title: Trevo® Retriever Registry Post Market Surveillance
    Description: The purpose of the Trevo® Retriever Registry is to collect real world performance data of the Trevo Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
    Investigator: David Bonovich, MD
    Eligibility: Subjects experiencing acute ischemic stroke who are eligible for restoration of blood flow using any approved Trevo Retriever in the neurovasculature to remove thrombus and the Trevo Retriever is the initial mechanical neuro-thrombectomy device used to remove the thrombus.
    Status: Active and open to enrollment
    Location: Eden Medical Center
    Contact: Catherine Ndungu-Case, (510) 727-8267
    Email: ndunguc@sutterhealth.org

    Title: Neuroform Microdelivery Stent System
    Description: Placement of cerebral coils/stents after stroke
    Investigator: David Bonovich, MD
    Eligibility: Subjects undergoing brain coil/stent placement - Humanitarian use device only
    Status: Active and open to enrollment
    Location: Eden Medical Center
    Contact: Catherine Ndungu-Case, 510-727-8267
    Email: ndunguc@sutterhealth.org

    Title: Wingspan Stent System With Gateway PTA Balloon Catheter
    Description: Placement of cerebral coils/stents after stroke.
    Investigator: David Bonovich, MD
    Eligibility: Subjects undergoing brain coil/stent placement - Humanitarian use device only.
    Status: Active and open to enrollment
    Location: Eden Medical Center
    Contact: Catherine Ndungu-Case, (510) 727-8267
    Email: ndunguc@sutterhealth.org

    Title: ARAMIS – Addressing Real-world Anticoagulant Management Issues in Stroke
    Description: The Addressing Real-world Anticoagulant Management Issues in Stroke (ARAMIS) registry is designed to provide important and timely insight into the management of acute stroke patients who are on novel oral anticoagulants in community practice.
    Investigator: David Bonovich, MD
    Eligibility: Patients who have had an acute ischemic stroke that has taken either dabigatran, rivaroxaban, apixaban, or edoxaban at least 7 days prior to admission OR patients who have had an intracerebral hemorrhage that has taken warfarin or one of the novel oral anticoagulants at least 7 days prior to admission.
    Status: Active and open to enrollment
    Location: Eden Medical Center
    Contact: Catherine Ndungu-Case, (510) 727-8267
    Email: ndunguc@sutterhealth.org

    Title: CARE Study: Case study to Assess Radiation Exposure in patients treated with the Penumbra coil 400
    Description: To gather data on radiation exposure in patients treated with the Penumbra Coil 400 system or Conventional coils per their respective indications for use.
    Investigator: David Bonovich, MD
    Eligibility: Patients treated with the PC 400 according to the IFU. Patients enrolled in the PC 400 arm must be those treated according to the cleared indication for the PC 400 System, which includes endovascular embolization of intracranial aneurysms.
    Status: Coming soon
    Location: Eden Medical Center
    Contact: Catherine Ndungu-Case, 510-727-8567
    Email: ndunguc@sutterhealth.org

    Title: iCAS: Imaging Collaterals in Acute Stroke Study
    Description:To determine if non-contrast arterial spin label MR imaging can help characterize collateral flow in patients with acute large vessel arterial stroke and which patients (ineligible or failed IV tPA), are most likely to benefit from IA treatment. The study is a direct comparison with the current state-of-the-art for clinical perfusion imaging, bolus contrast dynamic susceptibility contrast.
    Investigator: Jenny Chen, MD
    Eligibility: Patients 18 and older who have had an acute ischemic stroke that has taken either dabigatran, rivaroxaban, apixaban, or edoxaban at least 7 days prior to admission OR patients who have had an intracerebral hemorrhage that has taken warfarin or one of the novel oral anticoagulants at least 7 days prior to admission.
    Status: Coming soon
    Location: Eden Medical Center
    Contact: Catherine Ndungu-Case, 510-727-8567
    Email: ndunguc@sutterhealth.org

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