NCT01526824

Lovaza's Effect on Clopidogrel in a Neuro Population

The Effects of Polyunsaturated Omega-3 Fatty Acids (Lovaza) on Patients Taking Clopidogrel +/- Aspirin Who Have Suffered an Ischemic Stroke/TIA and/or Are Candidates for Neuroendovascular Stenting.

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Millard Fillmore Gates Hospital · Academic / Other
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

• Ischemic Stroke
• Transient Ischemic Attack

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	omega-3 polyunsaturated fatty acids (Lovaza)	Lovaza, 1 gram orally daily

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-02-06
• Last updated: 2012-02-06

Locations

1 site across 1 country: United States