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| Name | Class |
|---|---|
| Kaleida Health | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm, clopidogrel without Lovaza | No Intervention | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omega-3 polyunsaturated fatty acids (Lovaza) | Dietary Supplement | Lovaza, 1 gram orally daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| PRU and % inhibition of P2Y12 Assay | 20-30 days after initiation of the study |
| Measure | Description | 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 | |
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Inclusion Criteria:
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.
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)
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)
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
Uncontrolled hypertension
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Baxter, PharmD | Contact | 716-887-4401 | MBaxter@kaleidahealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Melissa Baxter, PharmD | Millmore Fillmore Gates Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Millmore Fillmore Gates Hospital | Recruiting | Buffalo | New York | 14209 | United States |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| C405603 | Omacor |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| Bleeding |
| 20-30 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |