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POINT: Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke

Sponsor: NIH
Principal Investigator: Carlos Kase, MD
Sub-investigators: Jose Romero MD, Thanh Nguyen MD, Viken Babikian MD, Hesham Masoud MD, Hugo Aparicio MD

Summary: A temporary loss of blood flow in the brain can cause sudden and brief disturbances in how the brain functions. This temporary loss is called a TIA (transient ischemic attack). During the TIA episode a person can have stroke-like symptoms for as long as 24 hours, after which the symptoms disappear completely. A TIA is often seen as a warning sign that a person might have a true stroke in the future if nothing is done to prevent it. In a true ischemic stroke, blood supply to part of the brain is decreased, leading to dysfunction of the brain tissue in that area. Clopidogrel (also known by the brand name Plavix®) is a type of medication called an antiplatelet drug, and it works by helping to keep platelets (small blood cells needed for normal blood clotting) in the blood from sticking together and forming harmful blood clots. This helps your blood flow more easily, and provides more protection against a future heart attack or stroke. Clopidogrel is approved for the prevention of a second stroke or TIA. Aspirin has also been shown to be effective in helping to prevent a second stroke or TIA.

Purpose: The purpose of this study is to determine the safety and effectiveness of the combination of low-dose aspirin and clopidogrel in reducing the risk of stroke, heart attacks and other complications in patients who have just had a transient ischemic attack or minor ischemic stroke.

Inclusion Criteria (highlights only):

  • >= 18 years old
  • 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 dose of 50-325 mg/day.

Status: Actively enrolling patients

More information and exclusion criteria on POINT