Lovaza's Effect on Clopidogrel in a Neuro Population

Status unconfirmed · Early Phase 1

Conditions studied: Ischemic Stroke, Transient Ischemic Attack

In brief

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.

Key facts

Study ID

NCT01526824

Run by

Millard Fillmore Gates Hospital

People needed

60

Starts

2011-09-01

Expected to finish

2013-09-01

Last updated by the study team

2012-02-06

Who can join

Age: 25 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Millmore Fillmore Gates Hospital — Buffalo, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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