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Lovaza's Effect on Clopidogrel in a Neuro Population

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Millard Fillmore Gates Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Kaleida Health
Information provided by (Responsible Party):
Melissa Baxter, Millard Fillmore Gates Hospital
ClinicalTrials.gov Identifier:
NCT01526824
First received: January 31, 2012
Last updated: February 1, 2012
Last verified: February 2012
  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)
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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 Millard Fillmore Gates Hospital:

Primary Outcome Measures:
  • PRU and % inhibition of P2Y12 Assay [ Time Frame: 20-30 days after initiation of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurologic events in each study [ Time Frame: 20-30 days after initiation of study ] [ Designated as safety issue: Yes ]
  • HDL, triglycerides, LDL, or total cholesterol [ Time Frame: 20-30 days after initiation of the study ] [ Designated as safety issue: No ]
  • 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

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Melissa Baxter, Neuroscience Clinical Pharmacy Coordinator, Millard Fillmore Gates Hospital
ClinicalTrials.gov Identifier: NCT01526824     History of Changes
Other Study ID Numbers: PHP1061010A
Study First Received: January 31, 2012
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ischemia
Ischemic Attack, Transient
Stroke
Brain Diseases
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Clopidogrel
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014