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Clinical Trials

A clinical trial is a method for medical researchers to study, test and discover effective treatments. Clinical trial research studies can occur in a lab or involve human beings.

Study Title: POINT- Platelet-Oriented Inhibitor in New TIA & Minor Stroke

PI: Victor Urrutia, MD

Summary: This study is a 2 arm, randomized, double-blind multi-center clinical trial, which tests whether a clopidogrel load, followed by clopidogrel daily, for 90 days is better than placebo to prevent recurrent cerebrovascular events, in patients with mild strokes or TIA that are taking aspirin. Enrollment is in the ER, within 12 hours of symptom onset. Study is part of the NETT (Neurologic Emergency Treatment Trials) grant. Funded, in part, by the National Institute of Neurological Disorders and Stroke (NINDS).

Human Study

Recruiting Status: Enrolling

Major inclusion criteria:

  • At least 18 years old
  • High risk TIA or minor ischemic stroke
  • Can be treated within 12 hours of symptom onset
  • Head CT or MRI ruling out hemorrhage other pathology to explain symptoms

Major exclusion criteria:

  • Patient is candidate for thrombolysis
  • GI bleeding or major surgery within 3 months
  • Clear indication for anticoagulation
  • Can’t swallow medication
  • Inability to provide informed consent

Study Title: IRIS-Insulin Resistance Intervention after Stroke Trial

PI: Richard Leigh, MD

Summary: A phase III, randomized, double-blind, placebo controlled trial that will test the hypothesis, that reducing insulin resistance and its sequelae, by using pioglitizone versus placebo, to prevent stroke and myocardial infarction among patients, with a recent ischemic stroke or transient ischemic attack, within 6 months of event. Funded by the National Institute of Neurological Disorders and Stroke (NINDS).

Human Study

Recruiting Status: Due to the success of trial enrollment at this site, we are continuing enrollment until December, 2012.

Major inclusion criteria:

  • Ages 40 years or greater at the time of randomization
  • Non-cardioembolic ischemic stroke no less than 14 days and no more than 6 months before randomization
  • Documentation of insulin resistance as defined by a value over 3.0 on the Homeostasis Model Assessment of insulin sensitivity
  • Fasting glucose <126 mg/

Major exclusion criteria:

  • Severely disabling stroke as indicated by a Rankin Grade above 3
  • Persons whose ischemic stroke was related to significant head trauma, carotid dissection, embolism from an artificial heart valve or medical instrumentation
  • Prior diagnosis of diabetes mellitus
  • HgbA1c >7.0 percent
  • Irreversible medical conditions likely to affect short-term survival
  • Severe neurologic or psychiatric disease

Study Title: DIAS 4 TRIAL (Phase 3 Trial to evaluate efficacy and safety of Desmotoplase in acute ischemic stroke patients)

PI: Victor Urrutia, MD

Summary: Randomized, double-blind parallel group placebo controlled phase III study to evaluate the efficiency & safety of desmotoplase in subjects with acute ischemic stroke.

Human Study

Recruiting Status: Enrolling

Major inclusion Criteria:

  • Diagnosis of acute ischemic stroke
  • Informed consent
  • Age between 18 and 85 years
  • Treatment can be initiated within 3 to 9 hours after the onset of stroke symptoms
  • NIHSS Score of 4 to 24
  • Vessel occlusion or high-grade stenosis on MRI or CTA in proximal cerebral arteries

Major exclusion Criteria:

  • Pre-stroke mRS >1
  • Previous exposure to desmoteplase
  • Extensive early infarction on MRI or CT in any affected area
  • Imaging evidence of ICH or SAH; AV malformation; cerebral aneurysm; or cerebral neoplasm
  • Internal carotid artery occlusion on the side of the stroke lesion
  • Treatment with heparin in the past 48 hours and a prolonged partial thromboplastin time
  • Treatment with oral anticoagulants and a prolonged prothrombin time
  • Treatment with glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single agent oral platelet inhibitors is permitted
  • Treatment with a thrombolytic agent within the past 72 hours

Study Title: SAIL-ON Safety of Intravenous Thrombolytics in Stroke on Awakening (SAIL-ON)

PI: Victor Urrutia, MD

Summary: This study is a Phase 2, one arm, open label study. The aim is to test the safety of IV rt-PA in stroke upon awakening. This study is funded in part by Genentech.

Recruiting Status: Enrolling

Major inclusion criteria:

  • At least 18 years old
  • Ability to provide informed consent
  • Diagnosis of acute ischemic stroke by history and physical exam
  • Pts will have woken up with stroke symptoms and present to the ED within 4.5 hours of awakening.
  • Able to receive t-PA within 4.5 hours of awakening
  • Pre morbid rankin of 0 or 1
  • MRI or CT scan with no hemorrhage and no major hypodensity or edema

Major exclusion criteria:

  • All the current exclusion criteria for the use of rt-PA in acute stroke within 3 hours of onset
  • No pregnant or lactating women
  • Inability to provide informed consent

Study Title: SMARTS Study of Motor Learning and Acute Recovery Time Course in Stroke

PI: John Krakauer, MD

Summary: This pilot study is to evaluate and quantify the biologic factors that are associated with the natural history of recovery over stroke, and to investigate the relationship between motor learning capacity and functional recovery over the course of 12 months post stroke. Funded by the James S. McDonnell Foundation.

Recruiting Status: Enrolling

Major inclusion criteria:

  • First ever clinical ischemic stroke which qualifies per MRI evaluation
  • Residual upper extremity weakness
  • Ability to provide informed consent

Major exclusion criteria

  • Too mild upper extremity impairment
  • Age <21
  • Receptive aphasia, global inattention
  • Inability to give informed consent
  • Other co-morbid conditions, or illnesses

A clinical study is an observational study on human subjects, but unlike clinical trials is strictly for research and not interventional. Please check back for information on our current studies.

 

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photo of Dr. Victor Urrutia The Stroke Prevention Connection, written by Dr. Urrutia, provides information on stroke treatment, prevention and rehabilitation.

 

ONLINE SEMINAR: Updates in Stroke Risk & Prevention

Watch Dr. Victor Urrutia share the latest research on stroke risk.

Watch the recording here

 

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