Lovaza's Effect on Clopidogrel in a Neuro Population


Phase 0 Results N/A

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)
- 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.