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Increased Drug ResistancePhase 1/2NCT00771914

The Effects of Omega-3 Fatty Acids on Aspirin Resistance

A Phase 1/2 study testing Aspirin, Lovaza and Both Aspirin and Lovaza in people with Increased Drug Resistance, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine if omega-3 fatty acids enhance the antiplatelet effects of aspirin. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Increased Drug Resistance
What is being tested?
Aspirin, Lovaza and Both Aspirin and Lovaza
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
27 participants
Where
1 siteUnited States
Study dates
Nov 2008to Jan 2009
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • History of alcohol abuse
  • Pregnancy by history or urine/serum pregnancy test
  • History of intestinal malabsorption syndrome including gastric bypass surgery

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Rochester School of Medicine and Dentistry

    Rochester, New York, 14642

Other trials in United States

About this study

The purpose of this study is to determine if omega-3 fatty acids enhance the antiplatelet effects of aspirin.

Read the 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.

Being tested
Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo
Keywords
aspirin, omega 3 fatty acids, Lovaza, myocardial infarction, aspirin resistance, cardiovascular disease
Medical subject headings
Myocardial Infarction, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AspirinDrug

    Aspirin 81mg tablet

  • LovazaDrug

    Also called ethyl EPA + DHA; fish oil

    Lovaza 4 grams

  • Both Aspirin and LovazaDrug

    Also called Lovaza and aspirin

    Lovaza 4 grams plus aspirin 81 mg

  • PlaceboOther

    Capsule resembling fish oil and a tablet resembling aspirin

Study groups in NCT00771914
Study groupRoleWhat they receive
Placebo, Lovaza, Aspirin, Both Aspirin and LovazaExperimentalFirst Placebo, then 4 grams of Lovaza, then 81mg of Aspirin, then both 4 grams of Lovaza and 81 mg of Aspirin
Receives: Drug: Aspirin; Drug: Lovaza; Drug: Both Aspirin and Lovaza; Other: Placebo
Aspirin, Lovaza, Both Aspirin and Lovaza, PlaceboExperimentalFirst 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo
Receives: Drug: Aspirin; Drug: Lovaza; Drug: Both Aspirin and Lovaza; Other: Placebo
Lovaza, Both Aspirin and Lovaza, Placebo, AspirinExperimentalFirst 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 81mg of Aspirin
Receives: Drug: Aspirin; Drug: Lovaza; Drug: Both Aspirin and Lovaza; Other: Placebo
Both Aspirin and Lovaza, Placebo, Lovaza, AspirinExperimentalFirst both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 4 grams of Lovaza, then 81mg of Aspirin
Receives: Drug: Aspirin; Drug: Lovaza; Drug: Both Aspirin and Lovaza; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the Difference Between the Time to Clot Formation in Seconds at Baseline and After Each Treatment

    The PFA-100 test measures platelet function as the time that it takes for a clot to form in a collagen-lined cartridge.

    Measured: 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionJan 2009
  4. Study completionJan 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00771914
Sponsor's protocol ID
Study Protocol 112421
Status last verified
Oct 2012
First submitted
14 Oct 2008
Last updated
6 Nov 2012
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Aspirin, Lovaza and Both Aspirin and Lovaza in people with Increased Drug Resistance, run by University of Rochester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the Difference Between the Time to Clot Formation in Seconds at Baseline and After Each Treatment (time frame: 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2012.

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