The Effects of Omega-3 Fatty Acids on Aspirin Resistance - Full Text View

Sponsor:	University of Rochester
Collaborators:	GlaxoSmithKline American College of Clinical Pharmacy Cornell University
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00771914

Purpose

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

Condition	Intervention	Phase
Aspirin Resistance	Drug: ethyl EPA + DHA	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	The Effects of Omega-3 Fatty Acids on Aspirin Resistance

Resource links provided by NLM:

Drug Information available for: Acetylsalicylic acid Docosahexaenoic acids Eicosapentaenoic acid Omacor

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

Platelet Function Analyzer 100 and Thromboxane A2 as measures of platelet aggregation [ Time Frame: 4 hours after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	November 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental All subjects will be randomized to Lovaza, aspirin, Lovaza and aspirin, and placebo, in a cross-over design	Drug: ethyl EPA + DHA Lovaza 4g, aspirin 81mg, Lovaza 4g plus 81mg, and placebo

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771914

Contacts

Contact: Robert C Block, MD, MPH	585 275-3356	robert_block@urmc.rochester.edu
Contact: Lisa Kakinami	585 273-5227	lisa_kakinami@urmc.rochester.edu

Locations

United States, New York
University of Rochester School of Medicine and Dentistry	Recruiting
Rochester, New York, United States, 14642
Contact: Robert C Block, MD, MPH 585-275-3356 robert_block@urmc.rochester.edu
Contact: Lisa Kakinami 585 273-5227 lisa_kakinami@urmc.rochester.edu

Sponsors and Collaborators

University of Rochester

GlaxoSmithKline

American College of Clinical Pharmacy

Cornell University

Investigators

Principal Investigator:

Robert C Block, MD, MPH

University of Rochester School of Medicine and Dentistry

More Information

No publications provided

Responsible Party:	University of Rochester School of Medicine and Dentistry ( Robert C Block, MD, MPH, FACP. Assistant Professor, Department of Community and Preventive Medicine and Consulting Lipidologist )
Study ID Numbers:	Study Protocol 112421
Study First Received:	October 14, 2008
Last Updated:	October 11, 2009
ClinicalTrials.gov Identifier:	NCT00771914 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Rochester:

aspirin
omega 3 fatty acids
Lovaza

myocardial infarction
aspirin resistance
cardiovascular disease

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents

Aspirin
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010