The Effects of Omega-3 Fatty Acids on Aspirin Resistance
Information source: University of Rochester
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Increased Drug Resistance
Intervention: Aspirin (Drug); Lovaza (Drug); Both Aspirin and Lovaza (Drug); Placebo (Other)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: University of Rochester Official(s) and/or principal investigator(s): Robert C Block, MD, MPH, Principal Investigator, Affiliation: University of Rochester School of Medicine and Dentistry
Summary
The purpose of this study is to determine if omega-3 fatty acids enhance the antiplatelet
effects of aspirin.
Clinical Details
Official title: The Effects of Omega-3 Fatty Acids on Aspirin Resistance
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: the Difference Between the Time to Clot Formation in Seconds at Baseline and After Each Treatment
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University of Rochester School of Medicine and Dentistry, Rochester, New York 14642, United States
Additional Information
Starting date: November 2008
Last updated: October 31, 2012
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