Stroke research is a vital component for patients at the Shands at University of Florida’s Stroke Program. Division Chief, Anna Khanna, MD, and her team are currently involved in National Institutes of Health (NIH) funded clinical trials related to stroke prevention, acute stroke therapy and neuroimaging in stroke.
Because of their active participation in these and other clinical stroke research trials, the Neurovascular team is aware of new stroke therapies and can discuss the best treatment options for stroke patients.
In turn, their patients benefit by having the latest information on stroke prevention and treatment and, as appropriate, can participate in clinical research.
Current Clinical Trials
The Shands at UF Stroke Program is currently participating in several clinical trials. The following links contain information about some of the therapies that the program is investigating.
POINT – Platelet-Oriented Inhibition in New TIA and minor ischemic stroke (POINT) Trial
Purpose: A randomized, double-blind, multi-center clinical trial to determine whether clopidogrel 75mg/day (after a loading dose of 600mg) is effective in improving survival free from major ischemic events (ischemic stroke, myocardial infarction, and ischemic vascular death) at 90 days when initiated within 12 hours of time last known to be free of new ischemic symptoms of TIA or minor ischemic stroke in subjects receiving 50-325mg/day of aspirin.
Inclusion Criteria: 1) Neurologic deficit (based on history or exam) attributed to focal brain ischemia and EITHER: A) High risk TIA – complete resolution of the deficit at the time or randomization *AND* an ABCD2 score ≥ 4, OR B) Minor Ischemic Stroke – residual deficit with NIHSS ≤ 3 at the time of randomization; 2) Ability to randomize within 12 hours of time last known free of new ischemic symptoms; 3) Head CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor or abscess, that could explain symptoms or contraindicate therapy; 4) Ability to tolerate aspirin at a dose of 50-325mg/day.
Exclusion Criteria: 1) Age < 18 years; 2) TIA symptoms limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo; 3) In the judgment of the treating physician, a candidate for thrombolysis endarterectomy or endovascular intervention; 4) Receipt of any intravenous or intra-arterial thrombolysis within 1 week prior to index event; 5) Gastrointestinal bleed or major surgery within 3 months prior to index event; 5) History of non-traumatic intracranial hemorrhage; 6) Clear indication for anticoagulation (e.g., warfare, heparin) anticipated during the study period (atrial fibrillation, mechanical heart valve, deep venous thrombosis, pulmonary embolism, antiphospholipid antibody syndrome, hypercoagulable state); 7) Qualifying ischemic event induced by angiography or surgery; 8) Severe non-cardiovascular comorbidity with life expectancy < 3 months; 9) Contraindications to clopidogrel or aspirin: A) Known allergy; B) Severe renal (serum cratinine > 2mg/dL) or hepatic insufficiency (prior or concurrent diagnosis, with INR>1.5, or an resultant complication, such as variceal bleeding, encephalopathy, or icterus); C) Hemostatic disorder or systemic bleeding in the past 3 months; D) Current thrombocytopenia (platelet count <100 x 109/l) or neutropenia/granulocytopenia (<1 x109/l); E) History of drug-induced hematologic or hepatic abnormalities. 10) Anticipated requirement for long-term (>7 day) nonstudy Antiplatelet drugs (e.g., dipyridamole, clopidogrel, ticlopidine) or NSAIDS affecting platelet function (such as prior vascular stent or arthritis); 11) Not willing or able to discontinue prohibited concomitant medications; 12) Inability to swallow medications; 13) At risk for pregnancy; premenopausal or postmenopausal woman within 12 months of last menses without a negative pregnancy test or non committing to adequate birth control (e.g., oral contraceptive, two methods of barrier birth control, or abstinence); 14) Unavailability for follow-up; 15) Inability to provide informed consent; 16) Other neurological conditions that would complicate assessment of outcomes during follow-up; 17) Ongoing treatment in another study of an investigational therapy, or treatment in such a study within the last 7 days.
Motor Function After Stroke
Purpose: To examine whether the Valmet66 BDNF polymorphism is related to recovery from stroke, particularly motor recovery, at 3 and 9 months post stroke.
Inclusion Criteria: 1) age 18-85; 2) history of ischemic stroke, radiologically verified as being supratentorial with onset 2-4 days prior to the time of the first study measurement; 3) Arm motor deficits that are neither mild nor devastating, defined as ARAT score 3-37 out of a normal 57; 4) able to attend all study sessions
Exclusion Criteria: 1) moderately-severely reduced alertness (NIH Stroke Scale question 1c must be 0); 2) severe aphasia (NIH Stroke Scale question 9 must score 0-1) or inability to speak English to an extend required for reasonable safe and compliant study participation; 3) reasonable likelihood of receiving standard post-stroke rehabilitation/therapy appropriate for clinical state; 4) another diagnosis having a major effect on arm/hand function; 5) pre-stroke arm/hand disability that was major in extent; 6) co-existent major neurological or psychiatric disease; 7) severe cardiopulmonary disease; 8) significant alcohol or drug abuse in the prior 3 years; 9) terminal medical diagnosis with likely < 6 months survival; 10) stroke deficits are judged unstable at time of baseline exam
Minimally Invasive Surgical Pulmonary Vein Insolation vs. Medical Management in Patients with Stroke Secondary to Atrial Fibrillation
Purpose: Atrial fibrillation is the most common cardiac arrhythmia in the United States, with 15% of all strokes attributed to atrial fibrillation with the atrial appendage implicated as the likely source of emboli in these patients. This study compares optimal medical therapy for this condition with a novel surgical ablative procedure that restores sinus rhythm and ligates the atrial appendage.
Inclusion Criteria: Patients with a history of stroke and paroxysmal, persistent or permanent atrial fibrillation.
Exclusion Criteria: 1) Recent stroke (<3 months); 2) age <18 or >80 with Ejection Fraction <40%; 3) presence of left atrial appendage thrombus on CT or echocardiography; 4) previous empyema or thoracic surgery or weight greater than 280 lbs. preventing access to the pulmonary veins via thoracoscopy; 5) left atrial diameter > 55 mm.; 6) contraindication to anticoagulation with Coumadin; 7) mitral insufficiency (>2+); 8) presence of ventricular arrhythmia requiring medication or AICD (automatic implantable cardiac defibrillator); 9) contraindications to MRI.
Intentional Disorders Associated with Hemispatial Neglect
Purpose: The purpose of the study is to understand the mechanism of attention shifts subsequent to unilateral left or right hemisphere stroke in the presence of biological and non-biological distraction.
Inclusion Criteria: 1) Left or Right hemisphere stroke (unilateral only); 2) >50 years of age
Exclusion Criteria: Other chronic neurological disorder (e.g., Parkinson’s disease, Alzheimers disease) or active psychiatric disorder other than depression.
Current Research Projects:
The Effects of Heart Failure and Cardiac Resynchronization on the Brain and Cognition
Purpose: The goal of this study is to determine the influence of increased blood flow through cardia resynchronization on the brain and cognition.
Investigator: John Williamson, Ph.D.
For more information on Stroke Clinical trials please consult the Stroke Clinical Trials Directory