Effects of Omacor and Aspirin on Platelet Function
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00688961 |
Recruitment Status :
Completed
First Posted : June 3, 2008
Last Update Posted : June 3, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Aspirin Drug: omega-3 acid ethyl esters | Early Phase 1 |

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 |
Actual Primary Completion Date : | August 2007 |
Actual Study Completion Date : | August 2007 |

Arm | Intervention/treatment |
---|---|
No Intervention: 1
Baseline
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Experimental: 2
Aspirin (1 day after a single, 625 mg dose)
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Drug: Aspirin
generic aspirin |
Experimental: 3
Omacor
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Drug: omega-3 acid ethyl esters
4, 1 g capsules q.d.
Other Names:
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Experimental: 4
Omacor plus aspirin
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Drug: Aspirin
generic aspirin Drug: omega-3 acid ethyl esters 4, 1 g capsules q.d.
Other Names:
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- Whole blood aggregometry in response to 4 agonists [ Time Frame: Day 1, 2, 29, and 30 ]

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

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
United States, South Dakota | |
Sanford Research/USD | |
Sioux Falls, South Dakota, United States, 57105 |
Responsible Party: | William S. Harris, Sanford Research/USD |
ClinicalTrials.gov Identifier: | NCT00688961 |
Other Study ID Numbers: |
WSH-001 |
First Posted: | June 3, 2008 Key Record Dates |
Last Update Posted: | June 3, 2008 |
Last Verified: | May 2008 |
omega-3 fatty acids aspirin platelet aggregation Healthy volunteers; no disease |
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 |