Lovaza's Effect on Clopidogrel in a Neuro Population

Recruiting

Phase 0 Results N/A

Trial Description

In patients who have suffered an ischemic stroke or TIA (mini-stroke), as well as in patients who are candidates for neuroendovascular stenting, it is standard of care to treat these patients with antiplatelet therapy, or "blood-thinners", the most common of which is clopidogrel (Plavix) with or without the addition of aspirin. A relatively common problem encountered with these patients is non-responsiveness to clopidogrel therapy. A prior study in cardiac patients showed that the addition of omega-3 polyunsaturated fatty acids (Lovaza, or "fish oil") can increase a patient's response to therapy with clopidogrel, but there have been no studies in neuro patients. In this study, patients will be divided into one of two groups: in the study arm, patients will receive clopidogrel +/- aspirin as well as Lovaza. In the control arm, patients will only receive clopidogrel +/- aspirin. Assays will be done to measure responsiveness to clopdiogrel on days 0, 12-24 hours after loading dose, day 3-5 if still inpatient, and at a follow-up visit 20-30 days after the start of the study. The investigators believe that this study will show an increase in platelet aggregation in patients receiving both clopidogrel and Lovaza.

Conditions

Interventions

  • Omega-3 polyunsaturated fatty acids (Lovaza) Dietary Supplement
    Intervention Desc: Lovaza, 1 gram orally daily
    ARM 1: Kind: Experimental
    Label: Clopidogrel plus Lovaza
    Description: This is the study arm of the trial, in which patients will be receiving either a standard dose (75mg daily) or high dose (150mg daily) clopidogrel with or without aspirin as well as therapy with daily Lovaza.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Pharmacodynamics Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary PRU and % inhibition of P2Y12 Assay 20-30 days after initiation of the study No
Secondary Neurologic events in each study 20-30 days after initiation of study Yes
Secondary HDL, triglycerides, LDL, or total cholesterol 20-30 days after initiation of the study No
Secondary Bleeding 20-30 days

Sponsors