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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.

For more information visit The Johns Hopkins Institution for Clinical and Translative Research (ICTR)

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
  • Patient cannot swallow medication
  • Patient cannot provide informed consent

Study Title: OPTIMIST: Optimal Post Tpa-IV Monitoring in Ischemic Stroke

PI: Victor Urrutia, MD

Summary: To show safety of post-tPA monitoring in a non-ICU setting for patients presenting with minor stroke symptoms (NIHSS<10)

Human Study

Recruiting Status: Enrolling

Major inclusion criteria:

  • Patients receiving IV tPA for presumed stroke within 4.5 hours of symptom onset
  • NIHSS <10 at presentation and at the end of tPA infusion
  • Age 18-80 years
  • Patients do not have ICU needs by the end of the tPA infusion

Major exclusion criteria:

  • Age <17 or >80
  • ICU need or indication by the end of the tPA infusion
  • NIHSS >9 at presentation or at the end of the tPA infusion
Proceedings:
At the end of the one-hour tPA infusion, eligible patients will be consented for this study and will continue with neurocheck and vital signs Q 15 minutes x 4 in the ED. The patient may transfer to the BRU after the third Q 15 minute interval, so that they receive the 4th in the BRU. After arrival to the BRU, they will receive a set of vital signs and neurochecks upon arrival and at one hour, then Q 2 hours for 8 hours and then Q 4 hours until completing the 24 hour post tPA.
 
 
 
 
 

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

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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