The Effects of Omega-3 Fatty Acids on Aspirin Resistance
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| ClinicalTrials.gov Identifier: NCT00771914 |
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Recruitment Status :
Completed
First Posted : October 15, 2008
Results First Posted : June 29, 2012
Last Update Posted : November 6, 2012
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Increased Drug Resistance | Drug: Aspirin Drug: Lovaza Drug: Both Aspirin and Lovaza Other: Placebo | Phase 1 Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 27 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | The Effects of Omega-3 Fatty Acids on Aspirin Resistance |
| Study Start Date : | November 2008 |
| Actual Primary Completion Date : | January 2009 |
| Actual Study Completion Date : | January 2009 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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
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Drug: Aspirin
Aspirin 81mg tablet Drug: Lovaza Lovaza 4 grams
Other Name: ethyl EPA + DHA; fish oil Drug: Both Aspirin and Lovaza Lovaza 4 grams plus aspirin 81 mg
Other Name: Lovaza and aspirin Other: Placebo Capsule resembling fish oil and a tablet resembling aspirin |
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Experimental: 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
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Drug: Aspirin
Aspirin 81mg tablet Drug: Lovaza Lovaza 4 grams
Other Name: ethyl EPA + DHA; fish oil Drug: Both Aspirin and Lovaza Lovaza 4 grams plus aspirin 81 mg
Other Name: Lovaza and aspirin Other: Placebo Capsule resembling fish oil and a tablet resembling aspirin |
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Experimental: 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
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Drug: Aspirin
Aspirin 81mg tablet Drug: Lovaza Lovaza 4 grams
Other Name: ethyl EPA + DHA; fish oil Drug: Both Aspirin and Lovaza Lovaza 4 grams plus aspirin 81 mg
Other Name: Lovaza and aspirin Other: Placebo Capsule resembling fish oil and a tablet resembling aspirin |
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Experimental: 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
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Drug: Aspirin
Aspirin 81mg tablet Drug: Lovaza Lovaza 4 grams
Other Name: ethyl EPA + DHA; fish oil Drug: Both Aspirin and Lovaza Lovaza 4 grams plus aspirin 81 mg
Other Name: Lovaza and aspirin Other: Placebo Capsule resembling fish oil and a tablet resembling aspirin |
- the Difference Between the Time to Clot Formation in Seconds at Baseline and After Each Treatment [ Time Frame: 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.
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| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 >20 000.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00771914
| United States, New York | |
| University of Rochester School of Medicine and Dentistry | |
| Rochester, New York, United States, 14642 | |
| Principal Investigator: | Robert C Block, MD, MPH | University of Rochester School of Medicine and Dentistry |
| Responsible Party: | Robert Block, Principal Investigator, University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00771914 History of Changes |
| Other Study ID Numbers: |
Study Protocol 112421 |
| First Posted: | October 15, 2008 Key Record Dates |
| Results First Posted: | June 29, 2012 |
| Last Update Posted: | November 6, 2012 |
| Last Verified: | October 2012 |
Keywords provided by Robert Block, University of Rochester:
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aspirin omega 3 fatty acids Lovaza |
myocardial infarction aspirin resistance cardiovascular disease |
Additional relevant MeSH terms:
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Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents |
Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |