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Effects of Omacor and Aspirin on Platelet Function

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ClinicalTrials.gov Identifier: NCT00688961
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : June 3, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
Omacor (now Lovaza) is a pharmaceutical omega-3 fatty acid product. Omega-3 fatty acids can affect blood clotting by altering the function of the blood platelets. Aspirin can do the same. The purpose of this study is to determine the individual and combined effects of these two agents on platelet function using a whole blood method.

Condition or disease Intervention/treatment Phase
Healthy Drug: Aspirin Drug: omega-3 acid ethyl esters Early Phase 1

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Effects of Omacor (Alone and With Aspirin) on Platelet Function in Healthy Subjects
Study Start Date : June 2007
Primary Completion Date : August 2007
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: 1
Baseline
Experimental: 2
Aspirin (1 day after a single, 625 mg dose)
Drug: Aspirin
generic aspirin
Experimental: 3
Omacor
Drug: omega-3 acid ethyl esters
4, 1 g capsules q.d.
Other Names:
  • Omacor
  • Lovaza
Experimental: 4
Omacor plus aspirin
Drug: Aspirin
generic aspirin
Drug: omega-3 acid ethyl esters
4, 1 g capsules q.d.
Other Names:
  • Omacor
  • Lovaza


Outcome Measures

Primary Outcome Measures :
  1. Whole blood aggregometry in response to 4 agonists [ Time Frame: Day 1, 2, 29, and 30 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects may be male or female and between the ages of 21 and 60,
  • Non-smokers,
  • Taking no medications, vitamin pills, nutritional supplements or herbal preparations.

Exclusion Criteria:

  • Subjects may not have a history of allergic reactions to aspirin, fish or fish oils.
  • Birth control pills are not allowed.
  • Subject cannot have an allergy to aspirin or to non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil, others), naproxen (Aleve, Naprosyn, Anaprox, others), indomethacin (Indocin), or ketoprofen (Orudis KT, Orudis, Oruvail), nabumetone (Relafen), oxaprozin (Daypro), or tartrazine.
  • Drinking more than three alcoholic beverages a day
  • 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,
    • heart disease,
    • high blood pressure,
    • gout,
    • asthma,
    • arthritis, or
    • nasal polyps.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688961


Locations
United States, South Dakota
Sanford Research/USD
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Sanford Research
More Information

Responsible Party: William S. Harris, Sanford Research/USD
ClinicalTrials.gov Identifier: NCT00688961     History of Changes
Other Study ID Numbers: WSH-001
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: June 3, 2008
Last Verified: May 2008

Keywords provided by Sanford Research:
omega-3 fatty acids
aspirin
platelet aggregation
Healthy volunteers; no 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
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics