Stroke Center Clinical Research Studies

Study Sponsor: National Institutes of Health (NIH) - National Institute for Neurologic Disorders and Stroke (NINDS) / StrokeNet / University of Michigan
Site Principal Investigator: Dawn Meyer, PhD, RN, FNP-C, FAHA (UCSD Health System La Jolla and Hillcrest)
Study Period: May 2019 - Present (UCSD)

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 an ischemic stroke.

Prior studies have shown a clear independent association between OSA, which has a prevalence similar to hypertension among stroke patients, and the development of stroke and poor outcomes after ischemic stroke. If the Sleep SMART hypotheses are confirmed, a new strategy to prevent stroke recurrence and improve stroke recovery will be available.

Please see the Sleep SMART ClinicalTrials.gov website (NCT03812653) for more information.

Study Sponsor: National Institutes of Health (NIH) - National Institute for Neurologic Disorders and Stroke (NINDS) / Massachusetts General Hospital
Site Principal Investigator: Brett Meyer, MD (UCSD Health System La Jolla and Hillcrest)
Study Period: September 2021 - Present (UCSD)

The overall goal of the DISCOVERY study is to better understand what factors contribute to changes in cognitive (i.e., thinking and memory) abilities in patients who experienced a stroke. The purpose of the study is to help doctors identify patients at risk for dementia (decline in memory, thinking and other mental abilities that significantly affects daily functioning) after their stroke so that future treatments may be developed to improve outcomes in stroke patients. For this study, a "stroke" is defined as either (1) an acute ischemic stroke (AIS, or blood clot in the brain), (2) an intracerebral hemorrhage (ICH, or bleeding in the brain), (3) or an aneurysmal subarachnoid hemorrhage (aSAH, or bleeding around the brain caused by an abnormal bulge in a blood vessel that bursts).

The investigators hypothesize that:

1. The size, type and location of the stroke play an important role in recovery of thinking and memory abilities after stroke, and pre-existing indicators of brain health further determine the extent of this recovery.
2. Specific stroke events occurring in individuals with underlying genetic or biological risk factors can cause further declines in brain heath, leading to changes in thinking and memory abilities after stroke.
3. Studying thinking and memory alongside brain imaging and blood samples in patients who have had a stroke allows for earlier identification of declining brain health and development of individualized treatment plans to improve patient outcomes in the future.

This is a prospective, multi-center, observational, nested-cohort study. A total of 8,000 patients hospitalized at the DISCOVERY clinical sites with acute-onset AIS, ICH or aSAH and no history of dementia will be enrolled.

All participants will undergo baseline screening for evidence of pre-stroke dementia. Those who pass baseline screening will complete a blood draw and a series of cognitive and functional assessments at baseline.

Participants will undergo in-person (3-6 months, 18 months) and telephone (annual) follow-up visits for the duration of the study to assess for longitudinal cognitive and functional outcomes. In addition to Tier 1 procedures, at each in-person follow-up visit, Tier 2 participants will also undergo brain MRI scanning, comprehensive cognitive assessment batteries and longitudinal blood collection; and Tier 3 participants will also complete a specialized imaging of the brain (amyloid- and tau-PET/CT scans), which is intended to identify special biomarkers of dementia.

Please see the DISCOVERY ClinicalTrials.gov website (NCT04916210) for more information.

Study Sponsor: National Institutes of Health (NIH) - National Institute for Neurologic Disorders and Stroke (NINDS) / StrokeNet / Harvard Medical School/Beth Israel Deaconess Medical Center
Site Principal Investigator: Thomas Hemmen, MD (UCSD Health System La Jolla and Hillcrest)
Study Period: December 2019 - Present (UCSD)

This is a multi-center, pragmatic, prospective, randomized, open-label, and blinded end-point assessment (PROBE) clinical trial. A total of 1456 patients presenting within 7 days of a spontaneous lobar ICH while taking statins will be randomized (1:1 ratio) to one of two treatment strategies: discontinuation vs. continuation (restarting) of statin therapy (using the same agent and dose that they were using at ICH onset). Randomization will take into account: clinical site, statin dose and indication (primary vs. secondary prevention), LDL level, current use and intent-to-use oral anticoagulants (OAC) and/or antiplatelets in the long-term post-ICH, and severity of ICH upon presentation as assessed by baseline ICH volume

Participating subjects will undergo baseline testing for APOAPOE genotype, and will be followed for 24 months to assess for the occurrence of recurrent symptomatic ICH or MACCE during the follow-up period. We will perform a competing risk survival analysis.

Please see the SATURN ClinicalTrials.gov website (NCT03936361)  for more information.

Study Sponsor: National Institutes of Health (NIH) - National Institute for Neurologic Disorders and Stroke (NINDS) / StrokeNet / University of Cincinnati
Site Principal Investigator: Brett Meyer, MD (UCSD Health System La Jolla and Hillcrest)
Study Period: December 2021 - Present (UCSD)

The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. Our central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of participants most likely to benefit, will improve outcomes at 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy.

The investigators will perform a global, Phase III, randomized, double-blind controlled trial of rFVIIa plus best standard therapy vs. placebo and best standard therapy alone. The investigators will include participants with a volume of ICH ≥ 2 and < 60 cc, no more than a small volume of intraventricular hemorrhage (IVH) (IVH score ≤ 7), age ≥ 18 and ≤ 80, Glasgow Coma Scale of ≥ 8, and treated within 120 minutes from stroke onset. To minimize time-to-treatment, the study will use emergency research informed consent procedures (including exception from informed consent (EFIC) in the United States) and mobile stroke units (MSUs), with a goal of ½ of participants treated within 90 minutes, as accomplished in the NINDS t-PA trials. The FASTEST Trial will include approximately 100 hospital sites and at least 15 MSUs in the NINDS-funded StrokeNet and key global institutions with large volumes of ICH patients and the ability to treat them within 120 minutes of stroke onset.  We plan to recruit 860 participants over 3½ years. Countries participating in the trial include the United States, Canada, Japan, Germany, Spain, and the United Kingdom.

Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or placebo. Participants in both arms will receive best medical therapy as per published AHA Guidelines for ICH, including a target systolic blood pressure of 140 mm Hg. The primary outcome (ordinal mRS with the following categories: 0-2, 3, and 4-6) will be determined at 180 days, but we will follow participants by remote assessment at 30 days and 90 days. To measure growth of ICH, all participants will have standard of care baseline non-contrast CT of the head and a repeat scan at 24 hours. Centralized volumetric measurements of ICH, IVH, and edema will be performed for both time points.

Please see the FASTEST ClinicalTrials.gov website (NCT03496883) for more information.

Study Sponsor: National Institutes of Health (NIH) - National Institute for Neurologic Disorders and Stroke (NINDS) / StrokeNet / Translational Sciences / University of Cincinnati
Site Principal Investigator: Royya Modir, MD (UCSD Health System La Jolla and Hillcrest)
Study Period: May 2024 - Present (UCSD)

SISTER is a Phase-II, prospective, randomized, placebo-controlled, blinded, dose finding trial that aims to determine the safety and preliminary efficacy of TS23, a monoclonal antibody against the alpha-2 antiplasmin (a2-AP), in acute ischemic stroke.

SISTER is a Phase II, Bayesian, adaptive, randomized, dose-finding trial of TS23 in patients with acute ischemic stroke. Patients with an anterior cerebral circulation acute ischemic stroke and present between 4.5 to 24 hours of their last known well with a presenting NIH Stroke Scale Score >/=6 and an imaging evidence of salvageable brain tissue will be eligible and will be approached for an informed consent for study participation. After informed consent is provided, the study will randomize to 4 doses of TS23 and placebo. The trial will enroll 300 subjects at up to 50 participating sites.

The effects of TS23 will be evaluated on two following primary outcomes using a utility function: 1) primary safety outcome: any intracerebral hemorrhage at 30 (+/-6) hours and 2) primary efficacy outcome: NIH Stroke Scale score at 30 (+/-6) hours after drug administration. The study will follow participants for 90 (+/-7) days.

Primary Objective: To identify a dose of TS23 that is safe and more efficacious than placebo for the treatment of patients from 4.5 to 24 hours of last known well, who have evidence of core-penumbra mismatch on perfusion imaging and are not a candidate for standard of care reperfusion therapies.

Please see the SISTER ClinicalTrials.gov website (NCT05948566) for more information.