Lovaza's Effect on Clopidogrel in a Neuro Population
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 25 - 80 |
| Updated: | 4/2/2016 |
| Start Date: | September 2011 |
| End Date: | September 2013 |
| Contact: | Melissa Baxter, PharmD |
| Email: | MBaxter@kaleidahealth.org |
| Phone: | 716-887-4401 |
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.
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.
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.
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