Inpatient trials

TIA or Minor Ischemic Stroke

POINT          hotline# 866-947-6468

Aspirin and Clopidogrel vs. Aspirin in patients within 12 hours of symptoms with NIHSS 3 or less or ABCD2 Score 4 or greater

Inclusion Criteria

  • Neurologic deficit (based on history or exam) attributed to focal brain ischemia and EITHER
    • High risk TIA: Complete resolution of the deficit at the time of randomization AND ABCD2 score 4 or greater
    • OR Minor ischemic stroke: residual deficit with NIHSS 3 or less at the time of randomization
  • Ability to randomize within 12 hours of symptom onset.
  • Head CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor, or abscess that could explain symptoms or contraindicate therapy.
  • Subject will be prescribed aspirin at a dose of 50-325 mg/day.

Exclusion Criteria

  • Age <18 years
  • TIA symptoms limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo.
  • Planned thrombolysis or endovascular intervention for the index event.
  • Receipt of any intravenous or intra-arterial thrombolysis within 1 week prior to index event
  • Gastrointestinal bleed or major surgery within 3 months prior to index event.
  • History of nontraumatic intracranial hemorrhage.
  • Known internal carotid artery stenosis >50% that could be responsible for symptoms.
  • Qualifying ischemic event induced by angiography or surgery.
  • Clear indication for anticoagulation (eg, warfarin, heparin) anticipated during the study period (atrial fibrillation, mechanical heart valve, deep venous thrombosis, pulmonary embolism, antiphospholipid antibody syndrome, hypercoagulable state).
  • Severe non-cardiovascular comorbidity with life expectancy ❤ months.
  • Contraindication to clopidogrel or aspirin:
    • Known allergy
    • Severe renal (serum creatinine >2 mg/dL) or hepatic insufficiency (prior or concurrent diagnosis, with INR>1.5, or any resultant complication, such as variceal bleeding, encephalopathy, or icterus)
    • Hemostatic disorder or systemic bleeding within the last 7 days
    • Current thrombocytopenia (platelet count <100 x109/l) or neutropenia (<1 x109/l)
    • History of drug-induced hematologic or hepatic abnormalities
  • Anticipated requirement for long-term (>7 days) nonstudy antiplatelet drugs (e.g., dipyridamole, clopidogrel, ticlopidine), or NSAIDs affecting platelet function (such as prior vascular stent or arthritis).
  • Not willing or able to discontinue prohibited concomitant medications.
  • Inability to swallow medications.
  • At risk for pregnancy: premenopausal or post menopausal woman within 12 months of last menses without a negative pregnancy test or not committing to adequate birth control (e.g., oral contraceptive, two methods of barrier birth control, or abstinence).
  • Unavailability for follow-up.
  • Inability to provide informed consent.
  • Other neurological conditions that would complicate assessment of outcomes during follow-up.
  • Current participation in any other study of investigational therapy, or participation in such a study within the last 7 days.

 

TIA/minor stroke BIOMARKER STUDY

Single blood draw into PAXgene tubes.

Inclusion Criteria:

  1. Suspected TIA or minor stroke (NIHSS 4 or less), mimics okay and encouraged – you don’t have to be sure its a TIA or stroke, just sure enough to plan a work-up
  2. Age 40 or older.
  3. Blood draw within 72 hours of TIA/minor stroke onset.

Exclusion Criteria.

  1.  Intracerebral hemorrhage, subarachnoid hemorrhage or other intracerebral lesion by CT or MRI other than positive DWI-MRI
  2.  Lymphoma / leukemia
  3. Blood dyscrasia
  4. Infection requiring antibiotics within 14d prior to TIA or up to 72h after TIA
  5. Immunosuppressive therapy
  6. Current illicit drug use
  7. Blood transfusion within the past 1 month
  8. Major surgery or trauma requiring hospitalization within the past 6 months
  9. Cancer requiring chemotherapy, radiation or surgery within the past year
  10. TIA caused by angiography or surgery
  11. Treatment with IV-tPA

 

Acute Ischemic Stroke

SHINE

Intensive glucose control with target glucose 80-130 vs routine target <180 in patients with NIHSS 3 – 22 and history of DM with glucose >110 or no DM and glucose >150 within 12 hours of symptom onset. Use initial fingerstick glucose

SHINE Study Hotline 800-915-7320

*On-call staff CANNOT assist with I-SPOT

Inclusion criteria

  • Age 18 years or older
  • Clinical diagnosis of ischemic stroke
  • Neuroimaging excludes intracranial hemorrhage (ICH)
  • Protocol treatment must begin within 12 hours after stroke symptom It is recommended, but not required, that treatment start within 3 hours of hospital arrival.
  • Known history of type 2 diabetes mellitus and glucose >110 mg/dL OR admission glucose ≥150 mg/dL in those w/o known diabetes mellitus (based on most recent finger stick blood glucose at participating site).
  • Baseline NIHSS score of 3-22(NIHSS must be assessed within 30 minutes prior to randomization. Randomization will be blocked if subject intubated.)
  • Pre-stroke modified Rankin Scale score = 0 for patients with an NIHSS score of 3-7
  • Pre-stroke modified Rankin Scale score = 0 or 1 for patients with an NIHSS score of 8-22

Exclusion criteria

  • Type 1 diabetes mellitus
  • Substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment
  • Experimental therapy for the enrollment stroke. IV tPA (up to 4.5 hrs) or IA tPA are allowed as are IA therapies including use of FDA cleared devices. Non FDA cleared devices are considered experimental and are excluded.
  • Known to be pregnant or breast-feeding at the time of study entry
  • Other serious conditions that make the patient unlikely to survive 90 days
  • Renal dialysis (including hemo or peritoneal dialysis)

 

BASE

Lab kits located in ED box, in S9 office (instructions for blood draw in lab kit)

Inclusion Criteria:

  • Stroke or TIA within 24 hours of onset
  • Patients >18 years of age
  • Signs and symptoms suggestive of AIS or TIA
  • Within 24 hrs of symptom onset or last known normal time
  • Head CT or MRI ruling out other pathology such as vascular malformation, hemorrhage, tumor or abscess which would likely be responsible for presenting neurologic symptoms

Exclusion Criteria:

  • Any central nervous system infection, i.e. meningitis or encephalitis in the past 30 days
  • Any form of head trauma, stroke or intracranial hemorrhage in the past 30 days
  • Any history of primary or metastatic brain cancer
  • Active cancer defined as a diagnosis of cancer, within 6 months before enrollment, any treatment for cancer within the previous 6 months, or recurrent or metastatic cancer.
  • Autoimmune diseases: such as lupus, rheumatoid arthritis, Crohn’s disease, ulcerative colitis
  • Active chronic infectious Diseases (eg. HIV/AIDS, hepatitis C)
  • Any underlying medical condition which in the opinion of the investigator would prohibit the patient from providing informed consent
  • Major surgery within three months prior to the index event

Three blood draws for stroke/TIA patients

  • Within 8 hours of symptom onset
  • 24 hours (+/-6)
  • 48 hours (+/- 6)

***TUBES CAN STAY AT ROOM TEMP UP TO 72 HOURS BEFORE FREEZING**