Ischemic Stroke, Transient Ischemic Attack
Conditions
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.
Interventions
DIETARY_SUPPLEMENTomega-3 polyunsaturated fatty acids (Lovaza)
Lovaza, 1 gram orally daily
Sponsors
Kaleida Health
Millard Fillmore Gates Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
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) * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PRU and % inhibition of P2Y12 Assay | 20-30 days after initiation of the study |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactMelissa Baxter, PharmD
Outcome results
None listed