Trial Search Results

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

A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic stroke is a cerebral infarction. In POINT, eligibility is limited to brain TIAs and to minor ischemic strokes (with an NIH Stroke Scale [NIHSS] score less than or equal to 3).

TIAs are common [25], and are often harbingers of disabling strokes. Approximately 250,000-350,000 TIAs are diagnosed each year in the US. Given median survival of more than 8 years [32], there are approximately 2.4 million TIA survivors. In a national survey, one in fifteen of those over 65 years old reported a history of TIA [33], which is equivalent to a prevalence of 2.3 million in older Americans. Based on the prevalence of undiagnosed transient neurological events, the true incidence of TIA may be twice as high as the rates of diagnosis [33]. Based on our review of the National Inpatient Sample for 1997-2003, there were an average of 200,000 hospital admissions for TIA each year, with annual charges climbing quickly in the period to $2.6 billion in 2003.

Composite endpoint of new ischemic vascular events: ischemic stroke, myocardial infarction or ischemic vascular death at 90 days.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

University of California, San Francisco

Collaborator: The EMMES Corporation

Stanford Investigator(s):

Intervention(s):

  • Drug: Clopidogrel
  • Drug: placebo

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - Neurological 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 of (greater than or equal to) 4 OR

      - Minor ischemic stroke: residual deficit with NIHSS of (less than or equal to) 3
      at the time of randomization

   - Ability to randomize within 12 hours of time last known free of new ischemic symptoms.

   - Head CT or MRI ruling out hemorrhage or other pathology, such as vascular
   malformation, tumor, or abscess, that could explain symptoms or contraindicate
   therapy.

   - Ability to tolerate aspirin at a does of 50-325 mg/day.

Exclusion Criteria

   - Age <18 years

   - TIA symptoms limited to isolated numbness, isolated visual changes, or isolated
   dizziness/vertigo.

   - In the judgment of the treating physician, a candidate for thrombolysis,
   endarterectomy or endovascular intervention, unless the subject declines both
   endarterectomy and endovascular intervention at the time of evaluation for
   eligibility.

   - 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.

   - Clear indication for anticoagulation (e.g., warfarin, heparin) anticipated during the
   study period (atrial fibrillation, mechanical heart valve, deep venous thrombosis,
   pulmonary embolism, antiphospholipid antibody syndrome, hypercoagulable state).

   - Qualifying ischemic event induced by angiography or surgery.

   - Severe non-cardiovascular comorbidity with life expectancy <3 months.

   - Contraindication to clopidogrel or aspirin.

      - Known allergy

      - Severe renal (serum creatinine >2 mg/dL or 176.8umol/L) or hepatic insufficiency
      (prior or concurrent diagnosis, with International Normalized Ratio (INR)>1.5 or
      any resultant complication, such as variceal bleeding, encephalopathy, or
      icterus)

      - Hemostatic disorder or systemic bleeding in the past 3 months

      - Current thrombocytopenia (platelet count <100 x10^9/l) or neutropenia (<1
      x10^9/l)

      - History of drug-induced hematologic or hepatic abnormalities

   - Anticipated requirement for long-term (>7 day) non-study antiplatelet drugs (eg,
   dipyridamole, clopidogrel, ticlopidine), or Non-steroidal Anti-inflammatory Drugs
   (NSAIDs) affecting platelet function (such as prior vascular stent or arthritis).

   - 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.

   - Signed and dated informed consent not obtained from patient.

   - Other neurological conditions that would complicate assessment of outcomes during
   follow-up.

   - Ongoing treatment in another study of an investigational therapy that may potentially
   interact with study drug, or treatment in such a study within the last 7 days.

   - Previously enrolled in the POINT study.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Rosen Mann
(650) 721-2645
Recruiting