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Lovaza's Effect on the Activation of Platelets (LEAP)
This study is currently recruiting participants.
Verified by Invitrox, April 2008
Sponsors and Collaborators: Invitrox
Reliant Pharmaceuticals
Information provided by: Invitrox
ClinicalTrials.gov Identifier: NCT00515541
  Purpose

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


Condition Intervention Phase
Cardiovascular Disease
Bleeding
Drug: Lovaza
Phase II

Drug Information available for: Omacor Fish oil Lipids
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Effect of the Omega n3 Fatty on Human Platelet Function

Further study details as provided by Invitrox:

Primary Outcome Measures:
  • Platelet response to escalating doses of Lovaza. [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Patient weight and Lipid profile response [ Time Frame: 24 Weeks ]
  • The Occurence of any type of Bleeding [ Time Frame: 23 weeks ]

Estimated Enrollment: 40
Study Start Date: September 2007
Estimated Study Completion Date: December 2008
Arms Assigned Interventions
A: Active Comparator
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
B: Active Comparator
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
C: Active Comparator
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
D: Active Comparator
Patient is regularly taking Warfarin daily and is not taking Aspirin or 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515541

Contacts
Contact: Jennifer A Garbarino, MA 919-843-5212 ext XXXX jennifer_garbarino@med.unc.edu
Contact: Carl Schuler, RN 919-843-4597 ext XXXX carl_schuler@med.unc.edu

Locations
United States, North Carolina
The University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Jennifer A Garbarino, MA     919-843-5215 ext XXXX     jennifer_garbarino@med.unc.edu    
Contact: Carl Schuler, RN     919-843-4597 ext XXXX     carl_schuler@med.unc.edu    
Principal Investigator: Mauricio Cohen, MD            
Sponsors and Collaborators
Invitrox
Reliant Pharmaceuticals
Investigators
Principal Investigator: Mauricio Cohen, MD The University of North Carolina at Chapel Hill
  More Information

Study ID Numbers: 07-1068
Study First Received: August 10, 2007
Last Updated: April 23, 2008
ClinicalTrials.gov Identifier: NCT00515541  
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

Study placed in the following topic categories:
Body Weight
Hemorrhage

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009