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Lovaza's Effect on Clopidogrel in a Neuro Population

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Melissa Baxter, Millard Fillmore Gates Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01526824
First Posted: February 6, 2012
Last Update Posted: February 6, 2012
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.
Collaborator:
Kaleida Health
Information provided by (Responsible Party):
Melissa Baxter, Millard Fillmore Gates Hospital
  Purpose
In patients who have suffered an ischemic stroke or TIA (mini-stroke), as well as in patients who are candidates for neuroendovascular stenting, it is standard of care to treat these patients with antiplatelet therapy, or "blood-thinners", the most common of which is clopidogrel (Plavix) with or without the addition of aspirin. A relatively common problem encountered with these patients is non-responsiveness to clopidogrel therapy. A prior study in cardiac patients showed that the addition of omega-3 polyunsaturated fatty acids (Lovaza, or "fish oil") can increase a patient's response to therapy with clopidogrel, but there have been no studies in neuro patients. In this study, patients will be divided into one of two groups: in the study arm, patients will receive clopidogrel +/- aspirin as well as Lovaza. In the control arm, patients will only receive clopidogrel +/- aspirin. Assays will be done to measure responsiveness to clopdiogrel on days 0, 12-24 hours after loading dose, day 3-5 if still inpatient, and at a follow-up visit 20-30 days after the start of the study. The investigators believe that this study will show an increase in platelet aggregation in patients receiving both clopidogrel and Lovaza.

Condition Intervention Phase
Ischemic Stroke Transient Ischemic Attack Dietary Supplement: omega-3 polyunsaturated fatty acids (Lovaza) Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Polyunsaturated Omega-3 Fatty Acids (Lovaza) on Patients Taking Clopidogrel +/- Aspirin Who Have Suffered an Ischemic Stroke/TIA and/or Are Candidates for Neuroendovascular Stenting.

Resource links provided by NLM:


Further study details as provided by Melissa Baxter, Millard Fillmore Gates Hospital:

Primary Outcome Measures:
  • PRU and % inhibition of P2Y12 Assay [ Time Frame: 20-30 days after initiation of the study ]

Secondary Outcome Measures:
  • Neurologic events in each study [ Time Frame: 20-30 days after initiation of study ]
  • HDL, triglycerides, LDL, or total cholesterol [ Time Frame: 20-30 days after initiation of the study ]
  • Bleeding [ Time Frame: 20-30 days ]

Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control arm, clopidogrel without Lovaza
These patients will be receiving standard of care therapy with either standard dose (75mg daily) or high dose (150mg daily) clopidogrel +/- aspirin based on physician discretion.
Experimental: Clopidogrel plus Lovaza
This is the study arm of the trial, in which patients will be receiving either a standard dose (75mg daily) or high dose (150mg daily) clopidogrel with or without aspirin as well as therapy with daily Lovaza.
Dietary Supplement: omega-3 polyunsaturated fatty acids (Lovaza)
Lovaza, 1 gram orally daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gender: Male and female
  • Age range: 25 - 80 years of age
  • Study population: Patients who require antiplatelet therapy with clopidogrel +/- aspirin who are candidates for neuroendovascular stenting or have had an ischemic stroke/TIA.
  • Eligible females will be: Non-pregnant nor lactating/breastfeeding; Be surgically sterile for at least 6 months, postmenopausal, or if heterosexually active and of childbearing potential, agree to continue to use an accepted method of birth control throughout the study.

Exclusion Criteria:

  • Any clinically significant abnormal finding uncovered during the physical examination and/or clinically significant abnormal laboratory result at screening according to the clinical judgment of the Investigators
  • Current alcohol abuse
  • Smokers unable to refrain from smoking during the clinical trial
  • Patients who are already taking anticoagulants or other antiplatelets (ticlopidine, prasugrel, dipyridamole, cilostazol), or patients already taking PUFAs
  • Patients taking medications known to interact with clopidogrel that cannot be held or changed due to increased risk of adverse health events.

    • Cytochrome P450 3A4 and 2C19 (CYP3A4, CYP2C19) inhibitors or substrates known to cause competitive inhibition
    • Proton pump inhibitors (PPIs)
    • NSAIDs
  • Pregnant women or lactating/breastfeeding women.
  • Active or recent major bleeding (within 14 days) using TIMI score (minor severity will be acceptable based on clinical examination/patient history)

    • Major severity-
  • Intracranial hemorrhage
  • Cardiac tamponade
  • Overt bleeding with a decrease in hemoglobin ≥ 5 g/dl or a decrease in hematocrit ≥ 15% (with or without an identifiable site)

    • Minor severity-
  • Spontaneous gross hematuria
  • Spontaneous hematemesis
  • Spontaneous hemoptysis
  • Observed bleeding with decrease in hemoglobin ≥ 3 g/dl but ≤ 5 g/dl (with an identifiable site)
  • History of gastric or duodenal ulcer
  • Platelet count < 100 x 109/L
  • Serum creatinine > 2 mg/dL
  • Liver injury (alanine transaminase level > 1.5 times upper limit of normal)
  • Recent surgery (within 14 days of study screening)
  • Known bleeding diathesis including but not limited to

    • Hemophilia
    • Von Willebrand disease
    • Leukemia
    • Clotting factor deficiencies
  • Uncontrolled hypertension

    • Sustained systolic blood pressure > 185 mmHg, despite treatment
    • Sustained diastolic blood pressure > 110 mmHg, despite treatment
  • Hypersensitivity or intolerance to clopidogrel, aspirin, PUFAs and/or documented fish allergy
  • Patients who are currently enrolled in a different study or who have taken an investigational medication 30 days prior to starting this study.
  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): NCT01526824


Contacts
Contact: Melissa Baxter, PharmD 716-887-4401 MBaxter@kaleidahealth.org

Locations
United States, New York
Millmore Fillmore Gates Hospital Recruiting
Buffalo, New York, United States, 14209
Contact: Melissa Baxter, PharmD       MBaxter@kaleidahealth.org   
Sub-Investigator: Robert Sawyer, MD         
Sub-Investigator: Adnan H Siddiqui, MD, PhD         
Sub-Investigator: Elad I Levy, MD, FACS, FAHA         
Sub-Investigator: L N Hopkins, MD         
Sub-Investigator: Ken Snyder, MD, PhD         
Sub-Investigator: Travis Dumont, MD         
Sub-Investigator: Shannon O'Brien, MD         
Sub-Investigator: Naveen Sajja, MD         
Sponsors and Collaborators
Millard Fillmore Gates Hospital
Kaleida Health
Investigators
Principal Investigator: Melissa Baxter, PharmD Millmore Fillmore Gates Hospital
  More Information

Responsible Party: Melissa Baxter, Neuroscience Clinical Pharmacy Coordinator, Millard Fillmore Gates Hospital
ClinicalTrials.gov Identifier: NCT01526824     History of Changes
Other Study ID Numbers: PHP1061010A
First Submitted: January 31, 2012
First Posted: February 6, 2012
Last Update Posted: February 6, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Stroke
Ischemia
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia
Aspirin
Ticlopidine
Clopidogrel
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
Purinergic P2Y Receptor Antagonists