Lovaza's Effect on Clopidogrel in a Neuro Population
Palavras-chave
Resumo
datas
| Última verificação: | 01/31/2012 |
| Enviado pela primeira vez: | 01/30/2012 |
| Inscrição estimada enviada: | 01/31/2012 |
| Postado pela primeira vez: | 02/05/2012 |
| Última atualização enviada: | 01/31/2012 |
| Última atualização postada: | 02/05/2012 |
| Data real de início do estudo: | 08/31/2011 |
| Data Estimada de Conclusão Primária: | 08/31/2013 |
| Data Estimada de Conclusão do Estudo: | 08/31/2013 |
Condição ou doença
Intervenção / tratamento
Dietary Supplement: Clopidogrel plus Lovaza
Fase
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| No Intervention: Control arm, clopidogrel without Lovaza 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. | |
| Experimental: Clopidogrel plus Lovaza 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. | Dietary Supplement: Clopidogrel plus Lovaza Lovaza, 1 gram orally daily |
Critério de eleição
| Idades qualificadas para estudar | 25 Years Para 25 Years |
| Sexos elegíveis para estudo | All |
| Aceita Voluntários Saudáveis | sim |
| Critério | 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. |
Resultado
Medidas de Resultado Primário
1. PRU and % inhibition of P2Y12 Assay [20-30 days after initiation of the study]
Medidas de Resultado Secundário
1. Neurologic events in each study [20-30 days after initiation of study]
2. HDL, triglycerides, LDL, or total cholesterol [20-30 days after initiation of the study]
3. Bleeding [20-30 days]
