Phase 2
N=27
The Effects of Omega-3 Fatty Acids on Aspirin Resistance
Increased Drug Resistance
Bottom Line
View on ClinicalTrials.gov: NCT00771914 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: Primary: the Difference Between the Time to Clot Formation in Seconds at Baseline and After Each Treatment — 0.0; 10.9; -6.5; 30.5 seconds — p=0.00
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Aspirin (Drug); Lovaza (Drug); Both Aspirin and Lovaza (Drug); Placebo (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Difference Between the Time to Clot Formation in Seconds at Baseline and After Each Treatment |
0.0; 10.9; -6.5; 30.5 | 0.00 sig |
Summary
The purpose of this study is to determine if omega-3 fatty acids enhance the antiplatelet effects of aspirin.
Eligibility 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 500 000, hematocrit 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
Data sourced from ClinicalTrials.gov (NCT00771914). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.