Stanford Stroke Center Clinical Trials

NAVIGATE ESUS - This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.  NCT02313909
PI: Nirali Vora, MD
STATUS: RECRUITING

iDEF - Futility Study of Deferoxamine Mesylate in Intracerebral Hemorrhage; A prospective, multi-center, double-blind, randomized, placebo-controlled, phase-II clinical trial.
The purpose of this study is to determine whether treating patients with a type of bleeding in the brain (intracerebral hemorrhage; ICH) with a drug called deferoxamine mesylate could be helpful in recovery after ICH. NCT02175225
PI: Chitra Venkatasubramanian, MBBS, MD
STATUS: RECRUITING

MISTIE III: A Phase III, Randomized, Open-Label, 500-Subject Clinical Trial of Minimally Invasive Surgery Plus rt-PA in the Treatment of Intracerebral Hemorrhage
The study will evaluate the efficacy and safety of Minimally Invasive Surgery plus 1 mg of rt-PA administered every eight hours for up to nine doses as compared to subjects treated with conventional medical management. NCT01827046
PI: Chitra Venkatasubramanian, MBBS, MD
STATUS: RECRUITING

SOCRATES –Acute Stroke Or Transient IsChaemic Attack TReated with Aspirin or Ticagrelor and Patient OutcomES
The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor vs aspirin for the prevention of major vascular events (composite of stroke, myocardial infarction [MI], and death) in patients with acute ischemic stroke or transient ischemic attack (TIA). NCT01994720
PI: Waimei Amy Tai, MD
STATUS: ENROLLMENT CLOSED

Glyburide Advantage in Malignant Edema and Stroke - Remedy Pharmaceuticals (GAMES-RP) Study
The purpose of this trial is to demonstrate the efficacy of RP-1127 (Glyburide for Injection) compared to placebo in subjects with a severe anterior circulation ischemic stroke who are likely to develop malignant edema.
Protocol ID: 26458, NCT01794182
Protocol Title: PI: Gregory Albers, MD
STATUS: ENROLLMENT CLOSED

Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-II: A Phase III Randomized Multicenter Clinical Trial of Blood Pressure Reduction for Hypertension in Acute Intracerebral Hemorrhage
The purpose of this trial is to determine the therapeutic benefit of the intensive systolic blood pressure (SBP)treatment compared with standard SBP treatment for 24 hours after randomization in reducing the proportion of patients with death and disability at
90 days among subjects with intracerebral hemorrhage.  Protocol ID: 20543, NCT01176565
PI: Chitra Venkatasubramaian, MD
STATUS: ENROLLMENT CLOSED

Advanced MR and CT Imaging for Understanding Acute Stroke Evolution and Predicting Response to Recanalization Therapy (SENSE 3) Protocol ID: 27214
This project aims to compare for the first time the diagnostic ability of CT and MR to reliably identify irreversibly damaged tissue, at-risk (but potentially salvageable) tissue, and the “leakiness” of injured vessels in acute stroke patients.
PI: Roland Bammer, PhD
STATUS: RECRUITING

Imaging Collaterals in Acute Stroke (iCAS)
The overall goal of the imaging the Collaterals in Acute Stroke (iCAS) study, is to identify and quantify cerebral blood flow (CBF) delivered via collateral routes using arterial spin labeling (ASL), a non-contrast MRI technique, and to determine its impact on ischemic lesion growth and patient outcome.  NCT02225730
PI: Gregory Zaharchuk, MD
STATUS: RECRUITING

Evaluation of Cerebral Edema in Acute Ischemic and Hemorrhagic Stroke Using Volumetric Integral Phase-shift Spectroscopy (VIPS):  a Pilot Study.
The Cerebrotech Intracranial Fluid monitor (VIPS) is a new non-invasive device that uses very low levels of radio waves to look at brain swelling. The purpose of this study is to see if the Cerebrotech monitor can measure values in patients with ischemic stroke and to see if these values correlate with other ways that are currently used to measure brain swelling (such as repeated CT scans).
PI: Karen Hirsch, MD
STATUS: RECRUITING

Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial, a Randomized, Double-blind, Multicenter Clinical Trial
The primary aim of this trial is to determine whether clopidogrel 75 mg/day by mouth is effective in reducing the 90-day risk of major ischemic vascular events. Protocol ID: 18552, NCT00991029
PI: Gregory Albers, MD/James Quinn, MD
STATUS: RECRUITING

Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial Protocol ID: 23077, NCT01369069
This is a Phase III multicenter, randomized and controlled clinical trial of 1400 patients within 12 hours of stroke symptom onset, with diabetes and glucose concentrations of over 110 mg/dL on initial evaluation to determine if treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80mg/dL - 130 mg/dL) will be safe and result in improved 3 month outcome after stroke.
PI: James Quinn, MD
STATUS: RECRUITING

SCAN--Comprehensive Stroke Recovery Study
The SCAN study brings together neuroscientists, engineers, and clinical researchers to elucidate the mechanisms that underlie successful stroke recovery. In the future, this knowledge will help to develop treatments to enhance recovery from stroke. This study aims to develop tools to better understand functional recovery and the mechanisms that underlie stroke recovery through the following assessments:  1) cognitive testing, 2) functional assessments, 3) MRI, 4) TMS/EEG and 5) blood sampling. Participants are assessed at baseline (<2 months post-stroke), 30 days, 90 days, 6 months, and 1 year.
PI: Marion Buckwalter MD, PhD; Maarten Lansberg,  MD, PhD
STATUS: RECRUITING

CT Perfusion to Predict Response to Recanalization in Ischemic Stroke Project (CRISP)
The goal of this project is to obtain sufficient preliminary data to optimally design a definitive study to assess the risks and benefits of new stroke treatments aimed at restoration of blood flow. Protocol ID: 22227, NCT01622517
PI: Maarten Lansberg, MD, PhD
STATUS: ENROLLMENT CLOSED

TIA Triage Study
Protocol ID: 19211, NCT01423201
PI: Gregory Albers, MD

Prognostic Value of MRI and Biomarkers in Comatose Post-Cardiac Arrest Patients
This study is designed to assess the value of state-of-the art brain imaging techniques (MRI), and blood tests in predicting outcome in patients after cardiac arrest.
Protocol ID: 14447
Protocol Title: PI: Karen Hirsch, MD
STATUS: ENROLLMENT CLOSED

CLEAR III Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
The goal of this project is to determine whether EVD placement with low-dose rt-PA improves modified Rankin Scale scores at 6 months (dichotomized Rankin 0-3 vs. 4-6) compared to subjects treated with EVD placement with placebo (normal saline).
Protocol ID: 15585, NCT00784134
PI: Chitra Venkatasubramaian, MD
STATUS: ENROLLMENT CLOSED