Ischemic Stroke Clinical Trial
Official title:
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.
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 25 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Millmore Fillmore Gates Hospital | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Millard Fillmore Gates Hospital | Kaleida Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PRU and % inhibition of P2Y12 Assay | 20-30 days after initiation of the study | No | |
Secondary | Neurologic events in each study | 20-30 days after initiation of study | Yes | |
Secondary | HDL, triglycerides, LDL, or total cholesterol | 20-30 days after initiation of the study | No | |
Secondary | Bleeding | 20-30 days |
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