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.
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- PRU and % inhibition of P2Y12 Assay
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Control arm, clopidogrel without Lovaza
These patients will be receiving standard of care therapy with either standard dose (75mg daily) or high dose (150mg daily) clopidogrel +/- aspirin based on physician discretion.
Clopidogrel plus Lovaza
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.
Intervention: omega-3 polyunsaturated fatty acids (Lovaza) (Dietary Supplement)
Outcomes
Primary Outcomes
PRU and % inhibition of P2Y12 Assay
Time Frame: 20-30 days after initiation of the study
Secondary Outcomes
- Neurologic events in each study(20-30 days after initiation of study)
- HDL, triglycerides, LDL, or total cholesterol(20-30 days after initiation of the study)
- Bleeding(20-30 days)
Investigators
Melissa Baxter
Neuroscience Clinical Pharmacy Coordinator
Millard Fillmore Gates Hospital