Status:
UNKNOWN
Lovaza's Effect on Clopidogrel in a Neuro Population
Lead Sponsor:
Millard Fillmore Gates Hospital
Collaborating Sponsors:
Kaleida Health
Conditions:
Ischemic Stroke
Transient Ischemic Attack
Eligibility:
All Genders
25-80 years
Phase:
EARLY_PHASE1
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 ant...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01526824
Start Date
September 1 2011
End Date
September 1 2013
Last Update
February 6 2012
Active Locations (1)
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1
Millmore Fillmore Gates Hospital
Buffalo, New York, United States, 14209