The Effects of Omega-3 Fatty Acids on Aspirin Resistance
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- the Difference Between the Time to Clot Formation in Seconds at Baseline and After Each Treatment
研究概览
简要总结
The purpose of this study is to determine if omega-3 fatty acids enhance the antiplatelet effects of aspirin.
详细描述
Although aspirin has been a stalwart treatment in the prevention and treatment of myocardial infarction and stroke, it does not have its expected effects in a significant proportion of the population. This phenomenon has been termed "aspirin resistance". Omega-3 fatty acid supplementation has been associated with a reduced risk of sudden cardiac death and myocardial infarction. The beneficial effects of omega-3s are considered to be partially due to their ability to prevent platelet aggregation. However, the ability of omega-3s to enhance the effects of aspirin in those who suffer from aspirin resistance has not been determined. It is known that aspirin stimulates the production of potent lipid mediators from omega-3 fatty acids and that these mediators have powerful antiinflammatory and tissue-protective effects. Thus, the treatment of individuals at high risk for myocardial infarction and stroke with both aspirin and a pharmaceutical-grade omega-3 fatty acid medication may be a powerful combination in the prevention and treatment of life-threatening cardiovascular disease.
Study Protocol: Non-smoking male and female subjects between the ages of 18 and 50 not taking any medications, vitamin pills, nutritional supplements, or herbal preparations were recruited. Subjects with a history of chronic diseases (e.g. cardiovascular, renal, hepatic, neurodegenerative, neoplastic, metabolic {diabetes}, hypertension; based on screening medical history, a complete blood count, and comprehensive metabolic profile), or allergic reactions to aspirin, fish, fish oils, or non-steroidal anti-inflammatory drugs were excluded. Other exclusions included drinking more than three alcoholic beverages a day, or having any of the following conditions: an ulcer or bleeding in the stomach, liver or kidney disease, bleeding or blood clotting disorder (e.g. hemophilia), congestive heart failure, fluid retention, high blood pressure, gout, asthma, arthritis, or nasal polyps. This was a randomized, placebo-controlled, double-blinded trial with a cross-over design. Each subject served as his/her own control. The study involved four visits four weeks apart, all hosted in the University of Rochester Clinical Research Center. At each separate study visit, each subject received (using a randomized protocol) placebo, 81 mg aspirin, 4 g Lovaza(R)(3.4g of EPA+DHA), or both aspirin and Lovaza(R). Thus, each subject received each of these treatments individually in a random fashion over the four visits. Subjects, Center staff, and investigators were blinded as to which treatment was given at each visit and this ensured by the study pharmacist making the tablets and capsules for each treatment appear identical. Prior to each visit, subjects ate a standard low-fat dinner the prior evening, then fasted for at least 8 hours prior to arrival at the Center. Subjects were required to abstain from taking aspirin or non-steroidal anti-inflammatory drugs for 10 days prior to each visit and omega-3 fatty acids for 30 days prior to the baseline study visit, and all subsequent clinic visits. Visits lasted approximately 6 hours, with subjects at bedrest. A venous catheter was placed in a peripheral vein (saline lock, 18 gauge or larger, {no heparin used} in the forearm) with blood drawn, at baseline and 4 hours post-treatment, into citrated tubes at each visit for Platelet Function Analyzer-100 (PFA-100-Siemens, Deerfield, IL) closure time testing. Subjects were provided with a standard low-fat breakfast after the baseline phlebotomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to participate by providing informed consent and committing to complete the study. This includes adhering to the study diet.
- •No chronic disease by history and based on a complete blood count and comprehensive metabolic profile.
- •Commitment to not taking aspirin, non-steroidal anti-inflammatory medications, and to limit fish intake to ≤2 meals during the 7 days prior to each CRC study period. They will also need to abstain from taking a list of over-the-counter medications that include aspirin. For the duration of the study, they will also be asked to abstain from taking fish and flax seed oil supplements.
排除标准
- •Reports the presence of chronic disease (e.g. cardiovascular, renal, hepatic, neurodegenerative, neoplastic, metabolic {diabetes}, hypertension).
- •Reports taking a systemic medication chronically.
- •History of serious adverse reaction or allergy to aspirin or fish oil.
- •Baseline platelet count <100 000 or >500 000, hematocrit <30%, or white blood cell count >20
- •Any abnormality from a screening CBC and complete blood count that suggests acute or chronic disease.
- •Nicotine user.
- •History of alcohol abuse
- •Pregnancy by history or urine/serum pregnancy test
- •History of intestinal malabsorption syndrome including gastric bypass surgery
研究组 & 干预措施
Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza
First Placebo, then 4 grams of Lovaza, then 81mg of Aspirin, then both 4 grams of Lovaza and 81 mg of Aspirin
干预措施: Aspirin (Drug)
Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza
First Placebo, then 4 grams of Lovaza, then 81mg of Aspirin, then both 4 grams of Lovaza and 81 mg of Aspirin
干预措施: Lovaza (Drug)
Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza
First Placebo, then 4 grams of Lovaza, then 81mg of Aspirin, then both 4 grams of Lovaza and 81 mg of Aspirin
干预措施: Both Aspirin and Lovaza (Drug)
Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza
First Placebo, then 4 grams of Lovaza, then 81mg of Aspirin, then both 4 grams of Lovaza and 81 mg of Aspirin
干预措施: Placebo (Other)
Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo
First 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo
干预措施: Aspirin (Drug)
Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo
First 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo
干预措施: Lovaza (Drug)
Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo
First 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo
干预措施: Both Aspirin and Lovaza (Drug)
Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo
First 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo
干预措施: Placebo (Other)
Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin
First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 81mg of Aspirin
干预措施: Aspirin (Drug)
Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin
First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 81mg of Aspirin
干预措施: Lovaza (Drug)
Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin
First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 81mg of Aspirin
干预措施: Both Aspirin and Lovaza (Drug)
Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin
First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 81mg of Aspirin
干预措施: Placebo (Other)
Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin
First both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 4 grams of Lovaza, then 81mg of Aspirin
干预措施: Aspirin (Drug)
Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin
First both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 4 grams of Lovaza, then 81mg of Aspirin
干预措施: Lovaza (Drug)
Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin
First both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 4 grams of Lovaza, then 81mg of Aspirin
干预措施: Both Aspirin and Lovaza (Drug)
Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin
First both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 4 grams of Lovaza, then 81mg of Aspirin
干预措施: Placebo (Other)
结局指标
主要结局
the Difference Between the Time to Clot Formation in Seconds at Baseline and After Each Treatment
时间窗: 4 hours
The PFA-100 test measures platelet function as the time that it takes for a clot to form in a collagen-lined cartridge.
次要结局
未报告次要终点
研究者
Robert Block
Principal Investigator
University of Rochester
