The Effects of Omega-3 Fatty Acids on Aspirin Resistance

NCT00771914 | Completed Phase 1 Results DMC

• 1 other identifier: Study Protocol 112421
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Increased Drug Resistance

Keywords

aspirin; omega 3 fatty acids; Lovaza; myocardial infarction; aspirin resistance; cardiovascular disease

Outcome Measures

Primary Outcomes (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.

  4 hours

Study Arms (4)

Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza

EXPERIMENTAL

First Placebo, then 4 grams of Lovaza, then 81mg of Aspirin, then both 4 grams of Lovaza and 81 mg of Aspirin

Drug: Aspirin; Drug: Lovaza; Drug: Both Aspirin and Lovaza; Other: Placebo

Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo

EXPERIMENTAL

First 81mg of Aspirin, then 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo

Drug: Aspirin; Drug: Lovaza; Drug: Both Aspirin and Lovaza; Other: Placebo

Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin

EXPERIMENTAL

First 4 grams of Lovaza, then both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 81mg of Aspirin

Drug: Aspirin; Drug: Lovaza; Drug: Both Aspirin and Lovaza; Other: Placebo

Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin

EXPERIMENTAL

First both 81mg of Aspirin and 4 grams of Lovaza, then placebo, then 4 grams of Lovaza, then 81mg of Aspirin

Drug: Aspirin; Drug: Lovaza; Drug: Both Aspirin and Lovaza; Other: Placebo

Interventions

Aspirin DRUG

Aspirin 81mg tablet

Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo; Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin; Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin; Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza

Lovaza DRUG

Lovaza 4 grams

Also known as: ethyl EPA + DHA; fish oil

Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo; Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin; Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin; Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza

Both Aspirin and Lovaza DRUG

Lovaza 4 grams plus aspirin 81 mg

Also known as: Lovaza and aspirin

Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo; Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin; Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin; Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza

Placebo OTHER

Capsule resembling fish oil and a tablet resembling aspirin

Aspirin, Lovaza, Both Aspirin and Lovaza, Placebo; Both Aspirin and Lovaza, Placebo, Lovaza, Aspirin; Lovaza, Both Aspirin and Lovaza, Placebo, Aspirin; Placebo, Lovaza, Aspirin, Both Aspirin and Lovaza

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• GlaxoSmithKline: collaborator
• American College of Clinical Pharmacy: collaborator
• Cornell University: collaborator

Study Sites (1)

University of Rochester School of Medicine and Dentistry

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Myocardial Infarction; Cardiovascular Diseases

Interventions

Aspirin; Omacor; Docosahexaenoic Acids; Fish Oils

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Oils

Results Point of Contact

• Title: Robert Block, MD, MPH, FACP
• Organization: University of Rochester Division of Epidemiology, Department of Community and Preventive Medicine

robert_block@urmc.rochester.edu

585-275-3356

Study Officials

• Robert C Block, MD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2008
• First Posted: October 15, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: November 6, 2012
• Results First Posted: June 29, 2012

Record last verified: 2012-10

Locations

US (1)