Lovaza's Effect on the Activation of Platelets (LEAP)

This study has been completed.
Sponsor:
Collaborator:
Reliant Pharmaceuticals
Information provided by (Responsible Party):
Invitrox
ClinicalTrials.gov Identifier:
NCT00515541
First received: August 10, 2007
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

This study is to determine the effects of Lovaza in platelet function studies


Condition Intervention Phase
Cardiovascular Disease
Bleeding
Drug: Lovaza
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of the Omega n3 Fatty on Human Platelet Function

Resource links provided by NLM:


Further study details as provided by Invitrox:

Primary Outcome Measures:
  • Platelet Aggegation (Arachiodonic Acid)Using a PAP-8E (BioData Corp.) [ Time Frame: up to and including closeout at 24 weeks ] [ Designated as safety issue: No ]
    The PAP-8E measures platelet aggregation in platelet rich plasma (PRP). Platelet responses to a series of common agonists cause changes in optical density that are measured. The instrument is blanked (100% baseline (optimal transmission)) by inserting a platelet poor plasma (PPP) specimen into the appropriate channel. The PRP is then inserted into the same well. The difference in optical density between the PPP and the PRP 0% baseline (optical transmission) is recorded for several minutes when the agonist reagent is added to the PRP.

  • Bleeding Time [ Time Frame: up to and including closeout at 24 weeks ] [ Designated as safety issue: No ]
    Bleeding time is a measure of how well platelets interact with blood vessel walls to form a clot. A manual blood pressure cuff is placed 2 inches above the antecubital fossa and inflated to 40mmHg. Using a standard Surgicutt device, a small incision is made and a stopwatch is started. The incision edge is blotted at 30 second intervals with standard filter paper until the bleeding has stopped. The time to hemostasis is noted.

  • EQELS (Electrophoretic Quasi Elastic Light Scattering: Change in Mobility After the Addition of Arachidonic Acid [ Time Frame: up to and including closeout at 24 weeks ] [ Designated as safety issue: No ]
    Measurements were made using a modified device (EQELS) to specifications of constant current, high electric field and a scattering angle of 30 degrees. EQELS provides a sensitive assessment of subtle changes in the cell surface that occurs with activation, ligand binding or apoptosis. These changes are the result of different distributions of charged groups that define a surface charge finger print for the current state of activation of the cell. Resting state platelets have a negative surface charge, whereas fully activated platelets have a positive surface charge.


Secondary Outcome Measures:
  • The Occurence of Any Type of Bleeding [ Time Frame: up to and including closeout at 24 weeks ] [ Designated as safety issue: Yes ]
    was there any bleeding occurance during the accessed interval


Enrollment: 43
Study Start Date: September 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Patient is not on Aspirin, Clopidogrel, or Warfarin and is taking escalating doses of study drug.
Drug: Lovaza
First 6 weeks period take 1 gram Lovaza capsule daily 2nd 6 weeks period take 2 grams of Lovaza (2 1 gram capsules) daily 3rd 6 weeks period take 4 grams of Lovaza (4 1 gram capsules) daily 4th 6 weeks period take 8 grams of Lovaza (8 1 gram capsules) daily
Active Comparator: B
Patient is on regular dose of Aspirin ( < or = 325mg). Patient is not taking Clopidogrel or Warfarin and is taking the escalating doses of Lovaza
Drug: Lovaza
First 6 weeks period take 1 gram Lovaza capsule daily 2nd 6 weeks period take 2 grams of Lovaza (2 1 gram capsules) daily 3rd 6 weeks period take 4 grams of Lovaza (4 1 gram capsules) daily 4th 6 weeks period take 8 grams of Lovaza (8 1 gram capsules) daily
Active Comparator: C
Patient is taking regularly 75mg of clopidogrel daily and Aspirin (< or = 325mg) and not taking Warfarin and is taking the escalating doses of Lovaza
Drug: Lovaza
First 6 weeks period take 1 gram Lovaza capsule daily 2nd 6 weeks period take 2 grams of Lovaza (2 1 gram capsules) daily 3rd 6 weeks period take 4 grams of Lovaza (4 1 gram capsules) daily 4th 6 weeks period take 8 grams of Lovaza (8 1 gram capsules) daily
Active Comparator: D
Patient is regularly taking Warfarin daily and Aspirin (< or = 325mg)and is not taking Clopidogrel and is taking the escalating doses of Lovaza
Drug: Lovaza
First 6 weeks period take 1 gram Lovaza capsule daily 2nd 6 weeks period take 2 grams of Lovaza (2 1 gram capsules) daily 3rd 6 weeks period take 4 grams of Lovaza (4 1 gram capsules) daily 4th 6 weeks period take 8 grams of Lovaza (8 1 gram capsules) daily

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males or females older than 18 years old who are able to ingest omega n3 fatty acids are eligible for this trial and are:
  • On no antiplatelet and anticoagulation therapy, OR
  • On chronic therapy with warfarin or aspirin alone (< or =325 mg/day)or combination therapy with clopidogrel and aspirin (< or =325 mg/day).
  • The subject must be able to read, understand, and sign an informed consent form and follow protocol.
  • To be enrolled in the study, subjects must be clinically stable on stable medical therapy throughout the duration of the study and meet the following criteria:
  • Healthy volunteers
  • Volunteers with stable coronary artery disease are those with:
  • Prior MI (>1 month) OR
  • Prior revascularization: angioplasty ± stenting (> 1 month) OR
  • Coronary artery bypass grafting (>3 months) OR
  • Documented disease on coronary angiography.
  • No planned no planned procedures or changes in medical therapies over the 24-week duration of the study
  • Volunteers with stable atrial fibrillation are those with:
  • Rate-controlled or paroxysmal atrial fibrillation on stable antiarrhythmic therapy.
  • On a stable dose of warfarin and regular follow-up in an anticoagulation ("coumadin") clinic.
  • No planned changes in antiarrhythmic therapies or cardioversion during the duration of the study.
  • No recent admissions for atrial fibrillation (> 3 months)
  • Subjects may not ingest other drugs known to cause a significant platelet abnormality while participating in this trial. (See list of prohibited medications, as outlined in Section 9)
  • Patients must be assessable to the investigator for scheduled clinic visits during the duration of the trial.
  • All female subjects of child bearing potential must have a negative serum pregnancy test prior to randomization and not plan on getting pregnant for the duration of the study.

Exclusion Criteria:

  • Any medical condition that would preclude ingestion of omega n3 fatty acids (Lovaza®).
  • Subjects taking nutritional supplements of fish oil or flaxseed oil. These patients may become eligible if they are willing to discontinue these nutritional supplements for a 2-week washout period.
  • Any other medical condition that would adversely affect the study objectives.
  • Chronic medical conditions known to be associated with abnormal platelet function including:
  • Liver dysfunction including abnormal liver function tests (AST, ALT, or alkaline phosphatase > upper limit of normal), known cirrhosis or chronic hepatitis.
  • Chronic kidney disease with a calculated creatinine clearance < 60 ml/min (MDRD) and/or a serum creatinine > 2.0 mg/dl.
  • History of significant anemia, or baseline hemoglobin < 11.0 g/dl.
  • Baseline PT>ULN, INR>1.3, and aPTT>ULN in subjects who are not on chronic warfarin therapy.
  • History of thrombocytopenia, or baseline platelet count of < 100,000
  • History of thrombocytosis, or baseline platelet count of > 600,000
  • Known bleeding diathesis and/or congenital hemostasis disorder and/or congenital platelet abnormalities.
  • Any history of stroke in the past 12 months.
  • History of peptic ulcer disease in the past year or gastrointestinal bleeding in the last 3 months.
  • Genitourinary bleeding in the last 3 months.
  • HIV or other infectious diseases that would expose laboratory personnel to unacceptable risks.
  • Treatment within 30 days with an antiplatelet agent other than aspirin or clopidogrel such as eptifibatide, tirofiban or abciximab.
  • Treatment within the past 7 days with unfractionated or low-molecular- weight heparin.
  • Allergy to iodine, fish, or other components of the study drug.
  • Alcohol or substance abuse.
  • Emotionally or psychiatrically unstable.
  • Use of any investigational drug or device within the past 30 days
  • Any other factor that the investigator feels would put the patient at increased risk if participating in the study.
  • Any Terminal illness or illness that may cause mortality that could obscure the results of the test in any way for them to appear inaccurate.
  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: NCT00515541

Sponsors and Collaborators
Invitrox
Reliant Pharmaceuticals
Investigators
Principal Investigator: Mauricio Cohen, MD University of North Carolina, Chapel Hill
  More Information

Publications:
Responsible Party: Invitrox
ClinicalTrials.gov Identifier: NCT00515541     History of Changes
Other Study ID Numbers: 07-1068
Study First Received: August 10, 2007
Results First Received: June 27, 2013
Last Updated: June 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Invitrox:
Platelet
Cardiovascular
Lipid
Fish Oil
Omega 3
DHA
EPA
Bleeding
Clotting
platelet function
Lipid profile
Weight and Bleeding risk

Additional relevant MeSH terms:
Cardiovascular Diseases
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014