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

Sponsors and Collaborators:	University of Rochester 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

Drug Information available for: Omacor Acetylsalicylic acid

U.S. FDA Resources

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

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
Rochester, New York, United States, 14642

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

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 14, 2008
ClinicalTrials.gov Identifier:	NCT00771914
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

Study placed in the following topic categories:

Aspirin
Infarction
Myocardial Infarction

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

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 January 16, 2009