lovaza's effect on clopidogrel in a neuro population

Conditions: Ischemic Stroke; Transient Ischemic Attack

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.


Eligibility criteria:
inclusion criteria: * gender: male and female * age range: 25 - 80 years of age * study population: patients who require antiplatelet therapy with clopidogrel +/- aspirin who are candidates for neuroendovascular stenting or have had an ischemic stroke/tia. * eligible females will be: non-pregnant nor lactating/breastfeeding; be surgically sterile for at least 6 months, postmenopausal, or if heterosexually active and of childbearing potential, agree to continue to use an accepted method of birth control throughout the study. exclusion criteria: * any clinically significant abnormal finding uncovered during the physical examination and/or clinically significant abnormal laboratory result at screening according to the clinical judgment of the investigators * current alcohol abuse * smokers unable to refrain from smoking during the clinical trial * patients who are already taking anticoagulants or other antiplatelets (ticlopidine, prasugrel, dipyridamole, cilostazol), or patients already taking pufas * patients taking medications known to interact with clopidogrel that cannot be held or changed due to increased risk of adverse health events. * cytochrome p450 3a4 and 2c19 (cyp3a4, cyp2c19) inhibitors or substrates known to cause competitive inhibition * proton pump inhibitors (ppis) * nsaids * pregnant women or lactating/breastfeeding women. * active or recent major bleeding (within 14 days) using timi score (minor severity will be acceptable based on clinical examination/patient history) * major severity- * intracranial hemorrhage * cardiac tamponade * overt bleeding with a decrease in hemoglobin ≥ 5 g/dl or a decrease in hematocrit ≥ 15% (with or without an identifiable site) * minor severity- * spontaneous gross hematuria * spontaneous hematemesis * spontaneous hemoptysis * observed bleeding with decrease in hemoglobin ≥ 3 g/dl but ≤ 5 g/dl (with an identifiable site) * history of gastric or duodenal ulcer * platelet count \< 100 x 109/l * serum creatinine \> 2 mg/dl * liver injury (alanine transaminase level \> 1.5 times upper limit of normal) * recent surgery (within 14 days of study screening) * known bleeding diathesis including but not limited to * hemophilia * von willebrand disease * leukemia * clotting factor deficiencies * uncontrolled hypertension * sustained systolic blood pressure \> 185 mmhg, despite treatment * sustained diastolic blood pressure \> 110 mmhg, despite treatment * hypersensitivity or intolerance to clopidogrel, aspirin, pufas and/or documented fish allergy * patients who are currently enrolled in a different study or who have taken an investigational medication 30 days prior to starting this study.