Clinical Trials for Stroke

Funded by the National Institute of Neurological Diseases and Stroke (NINDS), the UCSD Comprehensive Stroke Center is pioneering new techniques that could potentially extend brain-saving stroke treatment to more patients.

NIH StrokeNet: UCSD is one of the 25 designated Regional Stroke Coordinated Centers to promote and conduct high quality stroke trials. 

Current Clinical Research Studies:

POINT: Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke Trial

Study Sponsor:            National Institutes of Health (NIH) - National Institute for Neurologic

Disorders and Stroke (NINDS).

Site Principal Investigator: Dawn Meyer, PhD, FNP-C (UCSD Hillcrest and Thornton)

Site Principal Investigator: Royya Modir, MD (Scripps Mercy)

Study Period:   September 2011 – Present (UCSD)

Study Period:   April 2016 – Present (Scripps Mercy)

The POINT study seeks to determine the safety and effectiveness of the combination of low-dose aspirin and a medication called clopidogrel (also known by the brand name Plavix®) in reducing the risk of stroke, heart attacks and other complications in patients who have just had a minor ischemic stroke (lack of blood flow and oxygen to the brain usually caused by a blood clot) or a transient ischemic attack (TIA) (a condition that produces stroke-like symptoms such as sudden weakness on one side of the body or trouble speaking, but the symptoms are temporary lasting up to 12 hours).  Participants will be given a one-time large dose of clopidogrel 600mg (day 1) followed by clopidogrel 75 mg/day by mouth (day 2-90) versus placebo (day 1-90).  All patients will take aspirin every day.

Several studies that tested the combination of clopidogrel and aspirin have suggested that taking these two medications together may protect patients even more from major stroke and heart attack after a TIA or minor stroke, in comparison to taking aspirin alone, but these studies were small and the risk of bleeding was increased.

There will be approximately 5840 participants enrolled in about 350 hospitals internationally over 9 years. The total duration of this study is approximately 90 days for each patient.

Patients are most often identified for this study after presenting to the Emergency Department and being diagnosed with a TIA or minor stroke. 

For more information, please see the ClinicalTrials.gov website:

https://clinicaltrials.gov/ct2/show/NCT00991029


RESPECT – ESUS: Randomized, Double-Blind, Evaluation in Secondary Stroke Prevention Comparing the Efficacy and Safety of the  Oral Thrombin Inhibitor Dabigatran Etexilate (110 Mg Or 150 Mg, Oral B.I.D.) Versus Acetylsalicylic Acid (100 Mg Oral Q.D.) in Patients with Embolic Stroke of Undetermined Source

Study Sponsor: Boehringer Ingelheim

Site Principal Investigator: Royya Modir, MD (UCSD)

Study Period:   April 2016 – Present

RESPECT ESUS is a phase III, randomized, double-blind, evaluation in secondary stroke prevention

comparing the efficacy and safety of the oral thrombin inhibitor dabigatran etexilate (110 mg or 150 mg, oral b.i.d.) versus aspirin (100 mg oral q.d.) in patients with embolic stroke of undetermined source (ESUS).

The goal of this study is to demonstrate that the efficacy of dabigatran etexilate (110 mg b.i.d. or 150 mg b.i.d., with dosing according to age and renal function), is superior to aspirin (100 mg once daily) for the prevention of stroke recurrence in patients with embolic stroke of undetermined source. In addition, the trial will also characterize the safety of dabigatran etexilate in this setting. Patients with ischemic ESUS within the last 3 months, or within 6 months if aged ≥ 60 years and also have an additional risk factor for stroke, will be eligible for inclusion.

It estimated that 6000 participants will be enrolled into this study over a three year period. Average individual patient participation will be approximately 21 months.

For more information, please see the ClinicalTrials.gov website:

https://clinicaltrials.gov/ct2/show/NCT02239120

 

DEFUSE 3: Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3

Study Sponsor: NIH-NINDS (Sub Award through StrokeNET)

Site Principal Investigator: Brett Meyer, MD (UCSD Hillcrest)

Study Period:   April 2016 – Present (closed to recruitment)

The purpose of DEFUSE 3 is to assess the safety and efficacy of thrombectomy in carefully selected patients in an extended treatment time window. DEFUSE 3 is a prospective randomized Phase III multicenter controlled trial of patients with acute ischemic anterior circulation strokes due to large artery occlusion treated between 6-16 hours of stroke onset with endovascular thrombectomy therapy vs. control. Patients who meet the inclusion criteria will undergo either CT Perfusion/CTA or MR DWI/PWI/MRA studies prior to randomization. Patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile will be randomized in a 1:1 ratio to treatment with endovascular therapy (using one or more DEFUSE 3 approved thrombectomy devices) plus standard medical therapy versus standard medical therapy alone.

The primary endpoint, the modified Rankin Scale, will be assessed at 3 months. The patients’ participation in the study concludes at that time (3 months from stroke onset). The study will randomize up to 476 patients over 4 years.

For more information, please see the ClinicalTrials.gov website:

https://clinicaltrials.gov/ct2/show/NCT02586415

  

ACTION – 2: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Intravenous Natalizumab (BG00002) in Acute Ischemic Stroke

Study Sponsor: Biogen MA Inc

Site Principal Investigator: Thomas Hemmen, MD (UCSD Hillcrest)

Study Period:   August 2016 – Present (closed to recruitment)

The ACTION 2 study (also known as 101SK202) will assess dose response and overall safety and efficacy of natalizumab in subjects with acute ischemic stroke. The primary objective of the study is to assess the effects of natalizumab versus placebo in acute ischemic stroke on clinical measures of independence and activities of daily life.

This study will be conducted in patients aged 18 to 80 years with acute ischemic stroke defined by last known normal at ≤ 9 hours prior to study treatment initiation. All subjects will receive 1 dose of study treatment at Screening according to their randomization into 1 of the following 3 treatment groups: 1) 600 mg natalizumab IV; 2) 300 mg of natalizamab IV; 3) placebo IV.

The study will randomize approximately 240 subjects from 60 sites in the United States and Europe. Subjects will participate in this study for approximately 90 days.

For more information, please see the ClinicalTrials.gov website:

https://clinicaltrials.gov/ct2/show/NCT02730455

 

Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke

Study Sponsor: University of California, Irvine

Site Principal Investigator: Steven C. Cramer, MD (University of California, Irvine)

Study Period:   February 2015 – Present 

The current study will test the effectiveness of a novel home-based telehealth system designed to improve motor recovery and patient education after stroke. A total of 124 subjects (the number may be larger depending on the rate of subject dropout) with arm motor deficit 4-36 weeks after a stroke due to ischemia or to intracerebral hemorrhage will be randomized to receive 6 weeks of intensive arm motor therapy (a) in a traditional in-clinic setting or (b) via in-home telerehabilitation (rehabilitation services delivered to the subject's home via an internet-connected computer). The intensity, duration, and frequency of this therapy  will be identical across the two groups, with subjects in both treatment arms receiving 36 sessions (18 supervised and 18 unsupervised), 80 minutes each (including a 10 minute break), over 6 weeks. The primary endpoint is within-subject change in the arm motor Fugi-Meyer (FM) score from the Baseline Visit to 30 Day Follow-up Visit. Arm motor status is the focus here because it is commonly affected by stroke, is of central importance to many human functions, and is strongly linked to disability and well being after stroke.

For more information, please see the ClinicalTrials.gov website:

https://clinicaltrials.gov/ct2/show/NCT02