Lovaza's Effect on Clopidogrel in a Neuro Population
关键词
抽象
日期
| 最后验证: | 01/31/2012 |
| 首次提交: | 01/30/2012 |
| 提交的预估入学人数: | 01/31/2012 |
| 首次发布: | 02/05/2012 |
| 上次提交的更新: | 01/31/2012 |
| 最近更新发布: | 02/05/2012 |
| 实际学习开始日期: | 08/31/2011 |
| 预计主要完成日期: | 08/31/2013 |
| 预计完成日期: | 08/31/2013 |
状况或疾病
干预/治疗
Dietary Supplement: Clopidogrel plus Lovaza
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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 |
资格标准
| 有资格学习的年龄 | 25 Years 至 25 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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. |
结果
主要结果指标
1. PRU and % inhibition of P2Y12 Assay [20-30 days after initiation of the study]
次要成果指标
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]
