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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 ]

Enrollment:	26
Study Start Date:	November 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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 Other Name: Lovaza

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

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

No publications provided

Responsible Party:	Robert C Block, MD, MPH, FACP. Assistant Professor, Department of Community and Preventive Medicine and Consulting Lipidologist, University of Rochester School of Medicine and Dentistry
ClinicalTrials.gov Identifier:	NCT00771914 History of Changes
Other Study ID Numbers:	Study Protocol 112421
Study First Received:	October 14, 2008
Last Updated:	February 18, 2010
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:

Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents

Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012