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Effects of Omacor and Aspirin on Platelet Function
This study has been completed.
Sponsor:
Sanford Research
Information provided by:
Sanford Research
ClinicalTrials.gov Identifier:
NCT00688961
First received: May 30, 2008
Last updated: June 2, 2008
Last verified: May 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Healthy | Drug: Aspirin Drug: omega-3 acid ethyl esters | Early Phase 1 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Sanford Research:
Primary Outcome Measures:
- Whole blood aggregometry in response to 4 agonists [ Time Frame: Day 1, 2, 29, and 30 ]
| Enrollment: | 10 |
| Study Start Date: | June 2007 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
|
|
Experimental: 4
Omacor plus aspirin
|
Drug: Aspirin
generic aspirin
Drug: omega-3 acid ethyl esters
4, 1 g capsules q.d.
Other Names:
|
Show Detailed Description
Eligibility| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688961
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | May 30, 2008 |
| Last Updated: | June 2, 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 |
ClinicalTrials.gov processed this record on September 21, 2017